Where all of ophthalmology meets
AAO 2014
October 18–21
Subspecialty Day
FINAL
AAO 2014 Highlights...ix
2014 Board of Trustees ... xv
2014 Committe of Secretaries ... xvii
The Council... xxiii
AAO 2014 Overview ...xxvii
Meeting Directory ...xxxv
Shuttle Schedule ...xxxix
Awards
Laureate Recognition Award ...1
Special Awards ...4
Secretariat Award ...16
Achievement Award Program ...18
International Awards ...30
Visionary Society, Corporate and Organizational Donors ...31
Courses and Breakfasts
Selection Committees ...33
Programs-by-Day ...35
Breakfast With the Experts ...51
Instruction Course Progam ...58
Skills Transfer Program
Skills Transfer Program General Information ...101
Skills Transfer Course Contributors ...102
Skills Transfer Programs-by-Day ...103
Papers / Posters, Videos
Original Papers ...145
Scientific Posters...164
Video Program ...241
Special Meetings and Events
Special Meetings & Events...249
Learning Lounge ...253
Technology Pavilion ...258
Informational Posters ...262
AAOE Program / Practice Management
AAOE Program...265
AAOE Coding Sessions ...266
AAOE Instruction Courses ...267
Practice Management Master Classes...280
Exhibition, Indexes
Exhibitors...281
Product Index...285
Participant Index ...296
Participant Financial Disclosure Index ...307
CME & CE Credit ...325
Future Meeting Dates & Locations ...328
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INDICATIONS AND USAGE: For the treatment of superficial ocular infections involving the
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CONTRAINDICATIONS: This product should not be used in patients with a history of
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PRECAUTIONS: Bacitracin ophthalmic ointment should not be used in deep-seated ocular
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DOSAGE AND ADMINISTRATION: The ointment should be applied directly into the conjunctival
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AAO 2014
Join Us at the Opening Session
Sunday, Oct. 19, 8:30 - 10 AM
North, Hall B
Officially launch AAO 2014, in conjunction with the European Society of Ophthalmology (SOE).
• Congratulate award winners including the recipient of the 2014 Laureate Award: Jerry A. Shields, MD.
• Hear the 2014 Jackson Memorial Lecture, Retinoblastoma: 50 Years of Progress, by Hans E. Grossniklau,s MD, director
of the L.F. Montgomery Laboratory and the founding director of the Ocular Oncology and Pathology service of Emory Eye
Center. Dr. Grossniklaus is also Professor of Ophthalmology and Pathology, Oculo-Pathology, at the Emory University
School of Medicine.
• Listen to a distinguished panel discuss: Can We Better Prepare the Residents of 2015 for the Practice of 2020?
moder-ated by Thomas A. Oetting, MD. Panelists include: Nicholas J. Volpe, MD, Tara A. Uhler, MD, Paul Sternberg, Jr., MD
and Anthony C. Arnold, MD.
Three AAO-SOE Joint Sessions
Don’t miss the three AAO-SOE joint “View Across the Pond” symposia examining
differences between the United States and Europe in the areas of IOLs, cornea
and retina.
A View Across the Pond: Current Cataract and
IOL Practices in Europe and the United States
AAO
Virtual Meeting
The AAO Virtual Meeting allows you to
see live-streaming presentations or click
on recorded content throughout the
meet-HIGHLIGHTS
AAO 2014
Michael F Marmor MD Lecture in
Ophthalmology and the Arts
SYM09; Sunday, Oct. 19, 12:45 to 1:45PM
S406a
“Architecture, Ophthalmology and the Seeing of Space” will be
given by Mark Foster Gage, a recognized innovator in the fields of
architecture and design. In addition to being the principal of Mark
Foster Gage Architects (MFGA llc), in New York City, he also holds
the positions of Assistant Dean and tenured professor at the Yale
School of Architecture, where he has been on the faculty since
2001. His pioneering designs have received numerous awards,
been exhibited in museums and featured in the press.
The Bruce E. Spivey, MD Lecture in Risk
Management and Patient Safety
SPE15; Sunday, Oct. 19, 2:00 - 4:00 PM
S406b
Come hear Ajit K. Sachdeva, MD, FRSC, FACS, founding director
of the Division of Education at the American College of Surgeons,
lecture on education and training programs that enhance patient
safety and minimize risk of adverse outcomes. The lecture is
fol-lowed by the OMIC Forum.
NEW! Jones/Smolin Lecture
SYM26; Monday, Oct. 20, 10:15 - 11:45 AM
Grand Ballroom S100ab
“Changing Times in the Diagnosis and Management of Ocular
Infectious Diseases,” will be given by Russell N. Van Gelder, MD,
PhD, the Boyd K. Bucey Memorial Endowed Chair in
Ophthalmol-ogy and Professor in the Department of OphthalmolOphthalmol-ogy at the
University of Washington. The lecture will take place during the
Clinical Pearls in the Diagnosis of Masquerades in Infectious and
Inflammatory Disease of the Eye symposium.
Combined meeting with the Ocular Microbiology and Immunology
Group (OMIG)
NEW! Dr. Allan Jensen and Claire Jensen
Lecture in Professionalism and Ethics
SYM33; Monday, Oct. 20, 12:45 - 1:45 PM
S406a
“Promoting Ethics and Professionalism,” will be given by Gerald
B. Hickson, MD, Senior Vice President for Quality, Safety and
Risk Prevention, Assistant Vice Chancellor for Health Affairs, and
Joseph C. Ross Chair in Medical Education and Administration, at
Vanderbilt University Medical Center.
More Interactive Sessions
Dynamic experts lead discussions in informal settings throughout AAO 2014:
Learning Lounge
Saturday - Tuesday, Oct. 18 - 21
Booth 107
Float among the lounge’s theaters – new topics begin every 15
minutes.
Breakfast With the Experts
Sunday – Tuesday, Oct. 19 – 21, 7:30 - 8:30 AM
Scientific Poster Tours
Sunday, Oct. 19 and Monday, Oct. 20, 12:30-1:30 PM
The “Meeting Point” near Scientific Posters Online/
Videos on Demand, Booth 65.
Explore posters with your peers led by subject matter experts.
Ophthalmic Premier League:
A Team Video Competition on Managing
JOIN US!
October 18 – 20, 2014 | AAO Booth 1174 | McCormick Place
Monday, Oct 20
11:00 am – 11:30 am Pravin Dugel, MD 1:00 pm – 1:30 pm Peter Kaiser, MD 3:00 pm – 3:30 pm Peter Kaiser, MDSaturday, Oct 18
11:00 am – 11:30 am Pravin Dugel, MD 1:00 pm – 1:30 pm Baruch Kuppermann, MD 3:00 pm – 3:30 pm Baruch Kuppermann, MDSunday, Oct 19
11:00 am – 11:30 am Jay Duker, MD 1:00 pm – 1:30 pm Jay Duker, MD 3:00 pm – 3:30 pm Carl Regillo, MDPeter Kaiser, MD Carl Regillo, MD
Pravin Dugel, MD Jay Duker, MD Baruch Kuppermann, MD
Indication
JETREA (ocriplasmin) Intravitreal Injection, 2.5 mg/mL, is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion (VMA).
Important Safety Information
Warnings and Precautions• A decrease of ≥ 3 lines of best-corrected visual acuity (BCVA) was experienced by 5.6% of patients treated with JETREA and 3.2% of patients treated with vehicle in the controlled trials. The majority of these decreases in vision were due to progression of the condition with traction and many required surgical intervention. Patients should be monitored appropriately.
• Intravitreal injections are associated with intraocular inflammation/infection, intraocular hemorrhage and increased intraocular pressure (IOP). Patients should be monitored and instructed to report any symptoms without delay. In the controlled trials, intraocular inflammation occurred in 7.1% of patients injected with JETREA vs 3.7% of patients injected with vehicle. Most of the post-injection intraocular inflammation events were mild and transient. If the contralateral eye requires treatment with JETREA, it is not recommended within 7 days of the initial injection in order to monitor the post-injection course in the injected eye. • Potential for lens subluxation.
• In the controlled trials, the incidence of retinal detachment was 0.9% in the JETREA group and 1.6% in the vehicle group, while the incidence of retinal tear (without detachment) was 1.1% in the JETREA group and 2.7% in the vehicle group. Most of these events occurred during or after vitrectomy in both groups.
An overview of visual function and macular adverse events,
and OCT and ERG changes, as presented by leaders in the field.
Understanding JETREA® (ocriplasmin)
Intravitreal Injection, 2.5 mg/mL
Key Safety Topics
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
Please see the JETREA® package insert for full
Prescribing Information. 1 INDICATIONS AND USAGE
JETREA is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion.
2 DOSAGE AND ADMINISTRATION 2.1 General Dosing Information
Must be diluted before use. For single-use ophthalmic intravitreal injection only. JETREA must only be administered by a qualified physician.
2.2 Dosing
The recommended dose is 0.125 mg (0.1 mL of the diluted solution) administered by intravitreal injection to the affected eye once as a single dose.
2.3 Preparation for Administration
Remove the vial (2.5 mg/mL corresponding to 0.5 mg ocriplasmin) from the freezer and allow to thaw at room temperature (within a few minutes). Once completely thawed, remove the protective polypropylene flip-off cap from the vial. The top of the vial should be disinfected with an alcohol wipe. Using aseptic technique, add 0.2 mL of 0.9% w/v Sodium Chloride Injection, USP (sterile, preservative-free) into the JETREA vial and gently swirl the vial until the solutions are mixed.
Visually inspect the vial for particulate matter. Only a clear, colorless solution without visible particles should be used. Using aseptic technique, withdraw all of the diluted solution using a sterile #19 gauge needle (slightly tilt the vial to ease withdrawal) and discard the needle after withdrawal of the vial contents. Do not use this needle for the intravitreal injection.
Replace the needle with a sterile #30 gauge needle, carefully expel the air bubbles and excess drug from the syringe and adjust the dose to the 0.1 mL mark on the syringe (corresponding to 0.125 mg ocriplasmin). THE SOLUTION SHOULD BE USED IMMEDIATELY AS IT CONTAINS NO PRESERVATIVES. Discard the vial and any unused portion of the diluted solution after single use.
2.4 Administration and Monitoring
The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad spectrum microbiocide should be administered according to standard medical practice.
The injection needle should be inserted 3.5 - 4.0 mm posterior to the limbus aiming towards the center of the vitreous cavity, avoiding the horizontal meridian. The injection volume of 0.1 mL is then delivered into the mid-vitreous.
Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available. Following intravitreal injection, patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurred or decreased vision) without delay [see Patient Counseling Information]. Each vial should only be used to provide a single injection for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, and injection needles should be changed before JETREA is administered to the other eye, however, treatment with JETREA in the other eye is not recommended within 7 days of the initial injection in order to monitor the post-injection
5 WARNINGS AND PRECAUTIONS 5.1 Decreased Vision
A decrease of ≥ 3 line of best corrected visual acuity (BCVA) was experienced by 5.6% of patients treated with JETREA and 3.2% of patients treated with vehicle in the controlled trials [see Clinical Studies].
The majority of these decreases in vision were due to progression of the condition with traction and many required surgical intervention. Patients should be monitored appropriately [see Dosage and Administration].
5.2 Intravitreal Injection Procedure Associated Effects
Intravitreal injections are associated with intraocular inflammation / infection, intraocular hemorrhage and increased intraocular pressure (IOP). In the controlled trials, intraocular inflammation occurred in 7.1% of patients injected with JETREA vs. 3.7% of patients injected with vehicle. Most of the post-injection intraocular inflammation events were mild and transient. Intraocular hemorrhage occurred in 2.4% vs. 3.7% of patients injected with JETREA vs. vehicle, respectively. Increased intraocular pressure occurred in 4.1% vs. 5.3% of patients injected with JETREA vs. vehicle, respectively.
5.3 Potential for Lens Subluxation
One case of lens subluxation was reported in a patient who received an intravitreal injection of 0.175 mg (1.4 times higher than the recommended dose). Lens subluxation was observed in three animal species (monkey, rabbit, minipig) following a single intravitreal injection that achieved vitreous concentrations of ocriplasmin 1.4 times higher than achieved with the recommended treatment dose. Administration of a second intravitreal dose in monkeys, 28 days apart, produced lens subluxation in 100% of the treated eyes [see Nonclinical Toxicology].
5.4 Retinal Breaks
In the controlled trials, the incidence of retinal detachment was 0.9% in the JETREA group and 1.6% in the vehicle group, while the incidence of retinal tear (without detachment) was 1.1% in the JETREA group and 2.7% in the vehicle group. Most of these events occurred during or after vitrectomy in both groups. The incidence of retinal detachment that occurred pre-vitrectomy was 0.4% in the JETREA group and none in the vehicle group, while the incidence of retinal tear (without detachment) that occurred pre-vitrectomy was none in the JETREA group and 0.5% in the vehicle group.
5.5 Dyschromatopsia
Dyschromatopsia (generally described as yellowish vision) was reported in 2% of all patients injected with JETREA. In approximately half of these dyschromatopsia cases there were also electroretinographic (ERG) changes reported (a- and b-wave amplitude decrease).
6 ADVERSE REACTIONS
The following adverse reactions are described below and elsewhere in the labeling:
• Decreased Vision [see Warnings and Precautions]
• Intravitreal Injection Procedure Associated Effects
[see Warnings and Precautions and Dosage and Administration]
• Potential for Lens Subluxation [see Warnings
and Precautions]
• Retinal Breaks [see Warnings and Precautions and
Dosage and Administration]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
Approximately 800 patients have been treated with an intravitreal injection of JETREA. Of these, 465 patients received an intravitreal injection of ocriplasmin 0.125 mg (187 patients received vehicle) in the 2 vehicle-controlled studies (Study 1 and Study 2).
The most common adverse reactions (incidence 5% - 20%
half of these dyschromatopsia cases there were also electroretinographic (ERG) changes reported (a- and b-wave amplitude decrease).
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. Immunogenicity for this product has not been evaluated.
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted with ocriplasmin. There are no adequate and well-controlled studies of ocriplasmin in pregnant women. It is not known whether ocriplasmin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The systemic exposure to ocriplasmin is expected to be low after intravitreal injection of a single 0.125 mg dose. Assuming 100% systemic absorption (and a plasma volume of 2700 mL), the estimated plasma concentration is 46 ng/mL. JETREA should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mothers
It is not known whether ocriplasmin is excreted in human milk. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when JETREA is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
In the clinical studies, 384 and 145 patients were ≥ 65 years and of these 192 and 73 patients were ≥ 75 years in the JETREA and vehicle groups respectively. No significant differences in efficacy or safety were seen with increasing age in these studies.
10 OVERDOSAGE
The clinical data on the effects of JETREA overdose are limited. One case of accidental overdose of 0.250 mg ocriplasmin (twice the recommended dose) was reported to be associated with inflammation and a decrease in visual acuity.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity, mutagenicity or reproductive and developmental toxicity studies were conducted with ocriplasmin.
13.2 Animal Toxicology and/or Pharmacology
The ocular toxicity of ocriplasmin after a single intravitreal dose has been evaluated in rabbits, monkeys and minipigs. Ocriplasmin induced an inflammatory response and transient ERG changes in rabbits and monkeys, which tended to resolve over time. Lens subluxation was observed in the 3 species at ocriplasmin concentrations in the vitreous at or above 41 mcg/mL, a concentration 1.4-fold above the intended clinical concentration in the vitreous of 29 mcg/mL. Intraocular hemorrhage was observed in rabbits and monkeys.
A second intravitreal administration of ocriplasmin (28 days apart) in monkeys at doses of 75 mcg/eye (41 mcg/mL vitreous) or 125 mcg/eye (68 mcg/mL vitreous) was associated with lens subluxation in all ocriplasmin treated eyes. Sustained increases in IOP occurred in two animals with lens subluxation. Microscopic findings in the eye included vitreous liquefaction, degeneration/disruption of the hyaloideo- capsular ligament (with loss of ciliary zonular fibers), lens degeneration, mononuclear cell infiltration of the vitreous, and vacuolation of the retinal inner nuclear cell layer. These doses are 1.4-fold and 2.3-fold the intended clinical concentration in the vitreous of 29 mcg/mL, respectively.
14 CLINICAL STUDIES
The efficacy and safety of JETREA was demonstrated
The number of patients with at least 3 lines increase in visual acuity was numerically higher in the ocriplasmin group compared to vehicle in both trials, however, the number of patients with at least a 3 lines decrease in visual acuity was also higher in the ocriplasmin group in one of the studies (Table 1 and Figure 1).
Table 1: Categorical Change from Baseline in BCVA at Month 6, Irrespective of Vitrectomy (Study 1 and Study 2)
Figure 1: Percentage of Patients with Gain or Loss of ≥ 3 Lines of BCVA at Protocol-Specified Visits
16 HOW SUPPLIED/STORAGE AND HANDLING
Each vial of JETREA contains 0.5 mg ocriplasmin in 0.2 mL citric-buffered solution (2.5 mg/mL). JETREA is supplied in a 2 mL glass vial with a latex free rubber stopper. Vials are for single use only.
Storage
Store frozen at or below -4˚F ( -20˚C). Protect the vials from light by storing in the original package until time of use.
17 PATIENT COUNSELING INFORMATION
In the days following JETREA administration, patients are at risk of developing intraocular inflammation/ infection. Advise patients to seek immediate care from an ophthalmologist if the eye becomes red, sensitive to light, painful, or develops a change in vision [see Warnings and
Precautions].
Patients may experience temporary visual impairment after receiving an intravitreal injection of JETREA [see Warnings
and Precautions]. Advise patients to not drive or operate
heavy machinery until this visual impairment has resolved. If visual impairment persists or decreases further, advise patients to seek care from an ophthalmologist.
-15% -10% -5% 0% 5% 10% 15% Study 2 JETREA Study 2Vehicle
7 Days 14 28 90 180 Study 1 Vehicle Study 1 JETREA Study 1
JETREA Vehicle Difference
N=219 N=107 (95% CI)
≥ 3 line Improvement in BCVA Month 6 28 (12.8%) 9 (8.4%) 4.4 (-2.5, 11.2)
> 3 line Worsening in BCVA Month 6 16 (7.3%) 2 (1.9%) 5.4 (1.1, 9.7)
Study 2
JETREA Vehicle Difference
N=245 N=81 (95% CI)
≥ 3 line Improvement in BCVA Month 6 29 (11.8%) 3 (3.8%) 8.1 (2.3, 13.9)
> 3 line Worsening in BCVA Month 6 10 (4.1%) 4 (5.0%) -0.9 (-6.3, 4.5)
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AAO 2014
BOARD OF TRUSTEES
Gregory L Skuta MD
President
Russell N Van Gelder MD PhD
President-Elect
David W Parke II MD
Executive Vice President/CEO
Paul Sternberg Jr MD
Past President
George B Bartley MD
Editor, Ophthalmology
Cynthia A Bradford MD
Senior Secretary for Advocacy
Louis B Cantor MD
Senior Secretary for Clinical Education
Jane C Edmond MD
Trustee-at-Large
Alaa ElDanasoury MD
International Trustee-at-Large
Paul B Ginsburg MD
Public Trustee
Mathew W MacCumber MD PhD
Vice Chair, The Council
Frank J Martin MD
International Trustee-at-Large
Christie L Morse MD
Chair, FAAO Advisory Board
Thomas A Oetting MD
Trustee-at-Large
Mildred M G Olivier MD
Trustee-at-Large
Jonathan B Rubenstein MD
Secretary for Annual Meeting
John R Stechschulte MD
Trustee-at-Large
Humphrey J F Taylor
Public Trustee
Linda M Tsai MD
Trustee-at-Large
Ann A Warn MD MBA
Chair, The Council
Robert E Wiggins Jr MD MHA
Senior Secretary for Ophthalmic Practice
S E E YO U I N V I E N NA !
www.soe2015.org
AAO 2014
COMMITTEE
OF SECRETARIES
The Committee of Secretaries is directly involved in the development and management of program activities and services. This committee
plays an important role in program planning as well as providing recommendations to the board on the relative priority of major programs
within the Academy.
David W Parke II MD*
Chair
Richard L Abbott MD
Secretary for Global Alliances
George B Bartley MD*
Editor, Ophthalmology
Cynthia A Bradford MD*
Senior Secretary for Advocacy
Daniel J Briceland MD
Secretary for State Affairs
Louis B Cantor MD*
Senior Secretary for Clinical Education
Anne L Coleman MD PhD
Secretary for Quality of Care
Tamara R Fountain MD
Secretary for Member Services
Robert F Melendez MD MBA
Editor-in-Chief, the ONE Network
Secretary for Online Education/eLearning
Richard P Mills MD MPH
Chief Medical Editor, EyeNet Magazine
Jeffrey A Nerad MD
Secretary for Knowledge Base Development
Christopher J Rapuano MD
Secretary for Ophthalmic Knowledge
Michael X Repka MD
Academy Medical Director for Governmental Affairs
William L Rich III MD
Academy Medical Director of Health Policy
Philip R Rizzuto MD
Secretary for Communications
Jonathan B Rubenstein MD*
Secretary for Annual Meeting
Robert E Wiggins Jr MD MHA*
Senior Secretary for Ophthalmic Practice
George A Williams MD
Secretary for Federal Affairs
International Society of Refractive Surgery
A Partner of the American Academy of Ophthalmology
ISRS Chicago Schedule
REFRACTIVE SURGERY
SUBSPECIALTY DAY 2014: MISSION 20/20
The ISRS Annual Meeting
Friday, 17 October | 08:00 to 17:30
Saturday, 18 October | 08:00 to 17:30
Arie Crown Theater
Don’t miss the ISRS Award presentation
at 10:15 AM on Friday!
ISRS Member Lunch
Friday, 17 October | 12:30 to 13:30
E354, Lakeside Center
ISRS SPECIAL SESSIONS
Introduction to Corneal and Lens-Based
Refractive Surgery for Residents (SYM02)
Sunday, 19 October | 08:00 to 11:00
E450
Best of the Anterior Segment Specialty
Meetings 2014 (SYM41)
Monday, 20 October | 10:15 to 11:30
S406A
Decision Making in Contemporary Refractive
Surgery (SYM48)
Tuesday, 21 October | 10:15 to 11:45
S406A
ISRS ROUNTABLES*
Sunday, 19 October through Tuesday, 21 October
07:30 to 08:30
Hall A
ISRS INSTRUCTION COURSES*
Surgical Management of Astigmatism in
Cataract and Refractive Surgery (198)
Sunday, 19 October | 14:00 to 15:00
S103BC
Danger Zone: Refractive Surgery Nightmares
and Worst-Case Scenarios: A Video-Based
Course (314)
Monday, 20, October | 09:00 to 11:15
N140
ISRS Laser Refractive Surgery Course (131)
Monday, 20 October | 09:00 to 11:15
N138
Laser Refractive Surgery (LAB131A)
Monday | 15:30 to 17:30 | N227B
Laser Refractive Surgery (LAB131B)
Tuesday | 08:00 to 10:00 | N227B
A Step-by-Step Primer to Starting LASIK in
2014 (380)
Monday, 20 October | 14:00 to 16:15
S103BC
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This information pertains to all WaveLight® Excimer Laser Systems, including the WaveLight® ALLEGRETTO WAVE®, the ALLEGRETTO WAVE® Eye-Q , and the WaveLight® EX500.
Caution: Federal (U.S.) law restricts the WaveLight® Excimer Laser
Systems to sale by or on the order of a physician. Only practitioners who are experienced in the medical mangement and surgical treatment of the cornea, who have been trained in laser refractive surgery (including laser calibration and operation) should use a WaveLight® Excimer Laser System.
Indications: FDA has approved the WaveLight® Excimer Laser for use in
laser-assisted in situ keratomileusis (LASIK) treatments for: • the reduction or elimination of myopia of up to - 12.0 DS and up to
6.0 D of astigmatism at the spectacle plane;
• the reduction or elimination of hyperopia up to + 6.0 DS with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent of + 6.0 D; • the reduction or elimination of naturally occurring mixed astigmatism
of up to 6.0 D at the spectacle plane; and
• the wavefront-guided reduction or elimination of myopia of up to -7.0 DS and up to 3.0 D of astigmatism at the spectacle plane. In addition, FDA has approved the WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser System, when used with the WaveLight® ALLEGRO Topolyzer® and guided treatment planning software for topography-guided LASIK treatments for the reduction or elimination of up to -9.00 D of myopia, or for the reduction or elimination of myopia with astigmatism, with up to -8.00 D of myopia and up to 3.00 D of astigmatism. The WaveLight® Excimer Laser Systems are only indicated for use in patients who are 18 years of age or older (21 years of age or older for mixed astigmatism) with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.
Contraindications: The WaveLight® Excimer Laser Systems are
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• have a diagnosed collagen vascular, autoimmune or immunodeficiency disease;
• have been diagnosed keratoconus or if there are any clinical pictures suggestive of keratoconus; or
• are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*).
Warnings: The WaveLight® Excimer Laser Systems are not recommended
for use with patients who have:
• systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status;
• a history of Herpes simplex or Herpes zoster keratitis; • significant dry eye that is unresponsive to treatment; • severe allergies; or
• an unreliable preoperative wavefront examination that precludes wavefront-guided treatment.
• a poor quality preoperative topography map that precludes topography-guided LASIK treatment.
The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment. Topography-guided LASIK requires preoperative topography maps of sufficient quality to use for planning a topography-guided LASIK treatment. Poor quality topography maps may affect the accuracy of the topography-guided LASIK treatment and may result in poor vision after topography-guided LASIK.
Precautions: The safety and effectiveness of the WaveLight® Excimer Laser
• taking the medication sumatriptan succinate (Imitrex*); • corneal, lens and/or vitreous opacities including, but not limited
to cataract;
• iris problems including , but not limited to, coloboma and previous iris surgery compromising proper eye tracking; or
• taking medications likely to affect wound healing including (but not limited to) antimetabolites.
In addition, safety and effectiveness of the WaveLight® Excimer Laser Systems have not been established for:
• treatments with an optical zone < 6.0 mm or > 6.5 mm in diameter, or an ablation zone > 9.0 mm in diameter; or
• wavefront-guided treatment targets different from emmetropia (plano) in which the wavefront calculated defocus (spherical term) has been adjusted;
In the WaveLight® Excimer Laser System clinical studies, there were few subjects with cylinder amounts > 4 D and ≤ 6 D. Not all complications, adverse events, and levels of effectiveness may have been determined for this population.
Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatment on vision under poor illumination cannot be predicted prior to surgery.
Adverse Events and Complications
Myopia: In the myopia clinical study, 0.2% (2/876) of the eyes had a lost, misplaced, or misaligned flap reported at the 1 month examination. The following complications were reported 6 months after LASIK: 0.9% (7/818) had ghosting or double images in the operative eye; 0.1% (1/818) of the eyes had a corneal epithelial defect.
Hyperopia: In the hyperopia clinical study, 0.4% (1/276) of the eyes had a retinal detachment or retinal vascular accident reported at the 3 month examination.
The following complications were reported 6 months after LASIK: 0.8% (2/262) of the eyes had a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.
Mixed Astigmatism: In the mixed astigmatism clinical study, two adverse events were reported. The first event involved a patient who postoperatively was subject to blunt trauma to the treatment eye 6 days after surgery. The patient was found to have an intact globe with no rupture, inflammation or any dislodgement of the flap. UCVA was decreased due to this event. The second event involved the treatment of an incorrect axis of astigmatism. The axis was treated at 60 degrees instead of 160 degrees.
The following complications were reported 6 months after LASIK: 1.8% (2/111) of the eyes had ghosting or double images in the operative eye. Wavefront-Guided Myopia: No adverse events occurred during the postoperative period of the wavefront-guided LASIK procedures. In the Control Cohort (traditional LASIK treatment) one subject undergoing traditional LASIK had the axis of astigmatism programmed as 115 degrees instead of the actual 155 degree axis. This led to cylinder in the left eye. The following complications were reported 6 months after wavefront-guided LASIK in the Study Cohort: 1.2% (2/166) of the eyes had a corneal epithelial defect; 1.2% (2/166) had foreign body sensation; and 0.6% (1/166) had pain. No complications were reported in the Control Cohort. Topography-Guided Myopia: There were six adverse events reported in the topography-guided myopia study. Four of the eyes experienced transient or temporary decreases in vision prior to the final 12 month follow-up visit, all of which were resolved by the final follow-up visit. One subject suffered from decreased vision in the treated eye, following blunt force trauma 4 days after surgery. One subject experienced retinal detachment, which was concluded to be unrelated to the surgical procedure.
Clinical Data
Myopia: The myopia clinical study included 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%. Of the 782 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 98.3% were corrected to 20/40 or better, and 87.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: visual fluctuations (28.6% vs. 12.8% at baseline).
Long term risks of LASIK for hyperopia with and without astigmatism have not been studied beyond 12 months.
Mixed Astigmatism: The mixed astigmatism clinical study included 162 eyes treated, of which 111 were eligible to be followed for 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%. Of the 142 eyes eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 97.3% achieved acuity of 20/40 or better, and 69.4% achieved acuity of 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: sensitivity to light (52.9% vs. 43.3% at baseline); visual fluctuations (43.0% vs. 32.1% at baseline); and halos (42.3% vs. 37.0% at baseline). Long term risks of LASIK for mixed astigmatism have not been studied beyond 6 months.
Wavefront-Guided Myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized® LASIK (Control Cohort). 166 of the Study Cohort and 166 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.
Of the 166 eyes in the Study Cohort that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better. Of the 166 eyes in the Control Cohort eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20.
In the Study Cohort, subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: light sensitivity (47.8% vs. 37.2% at baseline) and visual fluctuations (20.0% vs. 13.8% at baseline). In the Control Cohort, the following visual symptoms were reported at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: halos (45.4% vs. 36.6% at baseline) and visual fluctuations (21.9% vs. 18.3% at baseline).
Long term risks of wavefront-guided LASIK for myopia with and without astigmatism have not been studied beyond 6 months.
Topography-Guided Myopia: The topography-guided myopia clinical study included 249 eyes treated, of which 230 eyes were followed for 12 months. Accountability at 3 months was 99.2%, at 6 months was 98.0%, and at 12 months was 92.4%. Of the 247 eyes that were eligible for the UCVA analysis at the 3-month stability time point, 99.2% were corrected to 20/40 or better, and 92.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms as “marked” or “severe” at an incidence greater than 5% at 1 month after surgery: dryness (7% vs. 4% at baseline) and light sensitivity (7% vs. 5% at baseline). Visual symptoms continued to improve with time, and none of the visual symptoms were rated as being “marked” or “severe” with an incidence of at least 5% at 3 months or later after surgery.
Long term risks of topography-guided LASIK for myopia with and without astigmatism have not been studied beyond 12 months.
Information for Patients: Prior to undergoing LASIK surgery with a
WaveLight® Excimer Laser System, prospective patients must receive a copy of the relevant Patient Information Booklet, and must be informed of the alternatives for correcting their vision, including (but not limited to) eyeglasses, contact lenses, photorefractive keratectomy, and other refractive surgeries.
Attention: Please refer to a current WaveLight® Excimer Laser System
Procedure Manual for a complete listing of the indications, complications, warnings, precautions, and side effects.
LOOK WHO’S DROPPING
INTO CHICAGO
Save the Date!
There’s strength in numbers. Lobby on Capitol Hill for
ophthalmology’s top legislative issues including advocating
for fair Medicare physician payment, reducing regulatory
burdens and vision research. Meet face-to-face with your
Members of Congress and show the might of our members at
this important event. It’s the most effective way to protect the
interests of our profession and our patients.
“Be an advocate for our patients and our
profession! Participate in Congressional
Advocacy Day and play a vital role
in communicating with our national
legislators about issues of importance
to ophthalmology during these critical
times. Join hundreds of your colleagues
and me in Washington, DC in 2015!”
Gregory L. Skuta, MD
Academy President
Registration opens in January 2015.
Congressional Advocacy Day is open to all
CONGRESSIONAL
ADVOCACY DAy
April 15 – 16, 2015
Washington, DC
The Council
The Council
Ann A Warn MD MBA – Chair
Mathew W MacCumber MD PhD – Vice
Chair
Councilors representing State Societies
Alabama Academy of Ophthalmology
Stephen J Kelly MD
Alaska Society of Eye Physicians and Surgeons
Scott A Limstrom MD
Arizona Ophthalmological Society
Thomas J McPhee MD
Arkansas Ophthalmological Society
Justine W Charton MD
California Academy of Eye Physicians and Surgeons
JoAnn A Giaconi MD Lynn K Gordon MD PhD Asa Dan Morton III MD Frank A Scotti MD
Colorado Society of Eye Physicians and Surgeons
Alan E Kimura MD MPH
Connecticut Society of Eye Physicians
Jeffrey R Sandler MD
Delaware Academy of Ophthalmology
Edward S A Jaoude MD
Florida Society of Ophthalmology
David B Cano MD
Stephen G Schwartz MD MBA Charles B Slonim MD FACS
Georgia Society of Ophthalmology
James Gerard Brooks Jr MD
Hawaii Ophthalmological Society
George Nardin MD
Kansas Society of Eye Physicians and Surgeons
William S Clifford MD
Kentucky Academy of Eye Physicians and Surgeons
David E Jones MD
Louisiana Ophthalmology Association
George S Ellis Jr MD FAAO FACS
Maine Society of Eye Physicians and Surgeons
Cynthia A Self MD
Maryland Society of Eye Physicians and Surgeons
Sanjay D Goel MD John T Thompson MD
Massachusetts Society of Eye Physicians and Surgeons
Michael H Goldstein MD Michael J Price MD
Michigan Society of Eye Physicians and Surgeons
Arezo Amirikia MD Anne M Nachazel MD
Minnesota Academy of Ophthalmology
Geoffrey G Emerson MD PhD
Mississippi Academy of Eye Physicians and Surgeons
Curtis D Whittington Jr MD
Missouri Society of Eye Physicians and Surgeons
P Kumar Rao MD
Montana Academy of Ophthalmology Brian D Sippy MD PhD
Nebraska Academy of Eye Physicians and Surgeons
David D Ingvoldstad MD
New York State Ophthalmological Society
Gary S Hirshfield MD James A Kinsey MD Martin E Lederman MD Stephen G Spitzer MD
North Carolina Society of Eye Physicians and Surgeons
J Stuart McCracken MD
North Dakota Society of Eye Physicians and Surgeons
Lance K Bergstrom MD
Ohio Ophthalmological Society
Anita Dash-Modi MD Bernard D Perla MD
Oklahoma Academy of Ophthalmology
Amalia Miranda MD
Oregon Academy of Ophthalmology
Mary P DeFrank MD
Pennsylvania Academy of Ophthalmology
James B Dickey MD Joanna M Fisher MD Karl R Olsen MD
Puerto Rican Society of Ophthalmology
Emilio A Arce-López MD
Rhode Island Society of Eye Physicians and Surgeons
Robert H Janigian Jr MD
South Carolina Society of Ophthalmology
Todd D Gwin MD
South Dakota Academy of Ophthalmology
Dustin L Dierks MD
Tennessee Academy of Ophthalmology
Ben B Mahan MD
Texas Ophthalmological Association The Council serves as the advisory body to the Board of Trustees. It was established in accordance with section 7.01 of the Bylaws of the American Academy of Ophthalmology.
The Council
The Council
Washington Academy of Eye Physicians and Surgeons
Brian E Bowe MD
Washington DC Metropolitan Ophthalmological Society
Reshma Katira MD
West Virginia Academy of Eye Physicians and Surgeons
Mark D Mayle MD
Wisconsin Academy of Ophthalmology
Deborah W Bernstein MD
Wyoming Ophthalmological Society
Anne Elizabeth Miller MD
Councilors representing Subspecialty and Specialized Interest Societies
American Academy of Pediatrics, Section on Ophthalmology
Gregg T Lueder MD
American Association for Pediatric Ophthalmology and Strabismus
David A Plager MD
American Association of Ophthalmic Oncologists and Pathologists
George Harocopos MD
American Board of Ophthalmology
John E Sutphin MD
American College of Surgeons, Advisory Council for Ophthalmic Surgery
Vikram D Durairaj MD Sarwat Salim MD
American Glaucoma Society
Thomas W Samuelson MD
American Ophthalmological Society
Thomas J Liesegang MD
American Osteopathic College of Ophthalmology
Kristin E Reidy DO
American Society of Cataract and Refractie
American Society of Retina Specialists
Peter K Kaiser MD Judy E Kim MD
American Uveitis Society
Justine R Smith MD
Association for Research in Vision and Ophthalmology
Emily Y Chew MD
Association of University Professors of Ophthalmology
Joel S Schuman MD
Association of Veterans Affairs Ophthalmologists
Mary Gilbert Lawrence MD MPH
Canadian Ophthalmological Society
Paul E Rafuse MD PhD
Contact Lens Association of Ophthalmologists
Bennie H Jeng MD
Cornea Society
Shahzad I Mian MD
Eye Bank Association of America
Woodford S Van Meter MD FACS
Macula Society
Michael J Elman MD
National Medical Association, Ophthalmology Section
Chasidy D Singleton MD
North American Neuro-Ophthalmology Society
Matthew Dean Kay MD
Ocular Microbiology and Immunology Group
Bradley Dean Fouraker MD
Outpatient Ophthalmic Surgery Society
Y Ralph Chu MD
Pan-American Association of Ophthalmology
Stephanie Jones Marioneaux MD
Retina Society
Jennifer I Lim MD
AAO 2014 Overview
AAO 2014 Overview
Thursday, Oct. 16
Event Time
Registration Attendees - onsite 4:00 - 6:00 pm
Attendees - satellite location 2:00 - 6:00 pm
Exhibitors 7:30 am - 6:00 pm
Ticket Sales 4:00 - 6:00 pm
Friday, Oct. 17
Event Time
Alumni & Related Group Functions All Day
Registration
Attendees - onsite 7:00 am - 5:00 pm
Attendees - satellite location 7:00 am - 5:00 pm
Exhibitors 7:00 am - 6:00 pm
Special Meetings & Events 7:30 am - 3:00 pm
Subspecialty Day Meetings Refractive Surgery 8:00 am - 5:15 pm
Refractive Surgery E-posters 7:00 am - 5:30 pm
Retina 8:00 am - 5:15 pm
Retina Exhibits 9:30 am - 5:30 pm
Ticket Sales 7:00 am - 5:00 pm
Saturday, Oct. 18
Event Time
AAOE/Practice Management: Introduction to Ophthalmic Coding and ICD-10-CM 8:00 - 11:00 am
AAOE/Practice Management: Coding Camp and Advanced ICD-10-CM 12:30 - 3:30 pm
AAOE/Practice Management Master Classes 8:00 am - 4:30 pm
Academy Café 1:15 - 4:30 pm
Alumni & Related Group Functions before 8:00 am &
after 5:30 pm Exhibition 9:00 am - 5:00 pm Learning Lounge 12:00 - 5:00 pm Registration Attendees 7:00 am - 5:00 pm Exhibitors 7:00 am - 5:00 pm Scientific Posters 9:00 am - 5:00 pm
AAO 2014 Overview
AAO 2014 Overview
Event Time
Subspecialty Day Meetings Cornea 8:00 am - 5:30 pm
Glaucoma 8:00 am - 5:00 pm
Ocular Oncology and Pathology 8:00 am - 5:15 pm
Oculofacial Plastic Surgery 8:00 am - 5:00 pm
Pediatric Ophthalmology 8:00 am - 5:00 pm
Refractive Surgery 8:00 am - 5:30 pm
Refractive Surgery E-posters 7:00 am - 5:00 pm
Retina 8:00 am - 5:30 pm Uveitus 7:30 am - 5:30 pm Symposia 2:00 - 5:30 pm Technology Pavilion 9:30 am - 5:00 pm Ticket Sales 7:00 am - 5:00 pm
Sunday, Oct. 19
Event TimeAAO 2014 Opening Session 8:30 - 10:00 am
AAO-SOE Joint Session, A View Across the Pond: Current Cataract and IOL Practices in Europe and the United States 2:00 - 3:30 pm
AAOE/Practice Management Courses 2:00 pm - 5:30 pm
AAOE/Practice Management General Session 10:00 am - 12:00 pm
Academy Business Meeting 10:00 - 10:30 am
Academy Café 10:30 am - 3:45 pm
Alumni & Related Group Functions before 8:00 am &
after 5:30 pm
Breakfast With the Experts 7:30 - 8:30 am
Exhibition 9:00 am - 5:00 pm
Fall Council Meeting 11:30 am - 5:00 pm
Instruction Courses 9:00 am - 5:30 pm
Learning Lounge 10:30 am - 5:00 pm
Orbital Gala 6:00 - 10:00 pm
Original Paper Sessions 10:30 am - 5:30 pm
Registration Attendees 7:00 am - 5:00 pm
Exhibitors 7:00 am - 5:00 pm
Scientific Posters 7:00 am - 5:00 pm
AAO 2014 Overview
AAO 2014 Overview
Event Time
Technology Pavilion 9:30 am - 5:00 pm
Ticket Sales 7:00 am - 5:00 pm
Young Ophthalmologist (YO) Program 10:00 am - 2:00 pm
Monday, Oct. 20
Event Time
AAO-SOE Joint Session, A View Across the Pond: Retina 8:30 - 10:00 am
AAOE/Practice Management Courses 9:00 am - 5:30 pm
Academy Café 8:30 - 11:45 am
Alumni & Related Group Functions before 8:30 am &
after 5:30 pm
Breakfast With the Experts 7:30 - 8:30 am
Exhibition 9:00 am - 5:00 pm
Instruction Courses 9:00 am - 5:30 pm
Learning Lounge 9:00 am - 5:00 pm
Original Paper Sessions 8:30 am - 5:30 pm
Registration Attendees 7:00 am - 5:00 pm
Exhibitors 7:00 am - 5:00 pm
Scientific Posters 7:00 am - 5:00 pm
Scientific Posters Online/Videos on Demand - Booth 65 7:00 am - 5:00 pm
Scientific Posters Online/Videos on Demand - Lakeside Center 8:00 am - 5:00 pm
Scientific Poster Tours 12:30 - 1:30 pm
Senior Ophthalmologist (SO) Program 2:30 - 5:00 pm
Skills Transfer Program 7:30 am - 4:30 pm
Special Meetings & Events 12:30 - 5:00 pm
Symposia and Spotlight Sessions 8:15 am - 5:15 pm
Technology Pavilion 9:30 am - 5:00 pm
Ticket Sales 7:00 am - 5:00 pm
Tuesday, Oct. 21
Event Time
AAO 2014 Overview
AAO 2014 Overview
Event Time
Original Paper Sessions 8:30 am - 12:45 pm
Registration Attendees 7:00 am - 1:00 pm
Exhibitors 7:00 am - 1:00 pm
Scientific Posters 7:00 am - 1:00 pm
Scientific Posters Online/Videos on Demand - Booth 65 7:00 am - 1:00 pm
Scientific Posters Online/Videos on Demand - Lakeside Center 8:00 am - 5:00 pm
Skills Transfer Program 8:00 am - 4:00 pm
Symposia 8:30 am - 12:15 pm
Technology Pavilion 9:30 am - 12:30 pm
Ticket Sales 7:00 am - 1:00 pm
Wednesday, Oct. 22
Event Time
28° Lo Mejor de la Academia en Español 2014 (The Best of the Academy in Spanish 2014) 8:00 am - 5:30 pm
For the treatment of elevated IOP
UNLOCK TREATMENT POSSIBILITIES
SIMBRINZA
™Suspension provided additional
1-3 mm Hg IOP lowering compared to
the individual components
1■ IOP measured at 8 AM, 10 AM, 3 PM, and 5 PM was reduced by
21-35%
at Month 32-4■ Effi cacy proven in two pivotal Phase 3 randomized, multicenter, double-masked, parallel-group, 3-month, 3-arm, contribution-of-elements studies2,3
■ The most frequently reported adverse reactions (3-7%) in a six month clinical trial were eye irritation, eye allergy, conjunctivitis, blurred vision, dysgeusia (bad taste), conjunctivitis allergic, eye pruritus, and dry mouth5
■ Only available beta-blocker-free fi xed combination2,3
Learn more at myalcon.com/simbrinza
INDICATIONS AND USAGE
SIMBRINZA™ (brinzolamide/brimonidine tartrate ophthalmic suspension)
1%/0.2% is a fi xed combination indicated in the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Dosage and Administration
The recommended dose is one drop of SIMBRINZA™ Suspension
in the affected eye(s) three times daily. Shake well before use. SIMBRINZA™ Suspension may be used concomitantly with other topical
ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least fi ve (5) minutes apart.
IMPORTANT SAFETY INFORMATION Contraindications
SIMBRINZA™ Suspension is contraindicated in patients who are
hypersensitive to any component of this product and neonates and infants under the age of 2 years.
Warnings and Precautions
Sulfonamide Hypersensitivity Reactions —Brinzolamide is a sulfonamide,
and although administered topically, is absorbed systemically. Sulfonamide attributable adverse reactions may occur. Fatalities have occurred due to severe reactions to sulfonamides. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
Corneal Endothelium—There is an increased potential for developing
corneal edema in patients with low endothelial cell counts.
Severe Hepatic or Renal Impairment (CrCl <30 mL/min)—SIMBRINZA™
Suspension has not been specifi cally studied in these patients and is not recommended.
Adverse Reactions
In two clinical trials of 3 months’ duration with SIMBRINZA™ Suspension,
the most frequent reactions associated with its use occurring in approximately 3-5% of patients in descending order of incidence included: blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy. Adverse reaction rates with SIMBRINZA™ Suspension were comparable to
those of the individual components. Treatment discontinuation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA™ Suspension patients.
Drug Interactions—Consider the following when prescribing SIMBRINZA™ Suspension:
Concomitant administration with oral carbonic anhydrase inhibitors is not recommended due to the potential additive effect. Use with high-dose salicylate may result in acid-base and electrolyte alterations. Use with CNS depressants may result in an additive or potentiating effect. Use with antihypertensives/cardiac glycosides may result in additive or potentiating effect on lowering blood pressure. Use with tricyclic antidepressants may blunt the hypotensive effect of systemic clonidine and it is unknown if use with this class of drugs interferes with IOP lowering. Use with monoamine oxidase inhibitors may result in increased hypotension.
For additional information about SIMBRINZA™ Suspension,
please see Brief Summary of full Prescribing Information on adjacent page.
