Food and Drug Administration Center for Drug Evaluation and Research

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Food and Drug Administration

Center for Drug Evaluation and Research

Summary Minutes of the Dermatologic and Ophthalmic Drugs Advisory Committee February 27, 2012

Topic: The committee was asked to comment on the appropriateness of marketing a single bottle of anti-inflammatory ophthalmic products for use in both eyes for post-surgical indications as it relates to the potential risk for infection. The FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.

These summary minutes for the February 27, 2012 Dermatologic and Ophthalmic Drugs Advisory Committee were approved on March 19, 2012.

I certify that I attended the February 27, 2012 Dermatologic and Ophthalmic Drugs Advisory Committee meeting and that these minutes accurately reflect what transpired.

______/s/_____________ ______/s/___________

Yvette Waples, Pharm.D. Michael Repka, M.D.

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The following is the final report of the Dermatologic and Ophthalmic Drugs Advisory Committee meeting held on February 27, 2012. A verbatim transcript will be available in approximately four weeks, sent to the Division of Transplant and Ophthalmology Products and posted on the FDA website at

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Dermatologicand OphthalmicDrugsAdvisoryCommittee/ucm280522.htm

All external requests for the meeting transcripts should be submitted to the CDER Freedom of Information Office.

______________________________________________________________________________ The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the Food and Drug Administration, Center for Drug Evaluation and Research, met on February 27, 2012 at the DoubleTree by Hilton Hotel Washington DC-Silver Spring, Silver Spring, Maryland. Prior to the meeting, the members and temporary voting members were provided the background

materials from the FDA. The meeting was called to order by Michael Repka, M.D. (Chair). The conflict of interest statement was read into the record by Yvette Waples, Pharm.D. (Designated Federal Officer). There were approximately 80 people in attendance. There was one Open Public Hearing speaker.

Issue: The committee was asked to comment on the appropriateness of marketing a single bottle of anti-inflammatory ophthalmic products for use in both eyes for post-surgical indications as it relates to the potential risk for infection. The FDA’s Center for Drug Evaluation and

Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate.

Attendance:

DODAC Members Present (Voting): Lynn K. Gordon, M.D., Ph.D.; Susan M. MacDonald, M.D.; Robert F. Melendez, M.D., M.B.A. (Consumer Representative); Michael X. Repka, M.D. (Chair)

DODAC Members Not Present (Voting): Jean L. Bolognia, M.D.; Lynn A. Drake, M.D; Sancy A. Leachman, M.D., Ph.D.; Paul F. Lizzul, M.D., Ph.D., M.P.H., M.B.A; Mary E. Maloney, M.D.; Ronald P. Rapini, M.D.; Allan R. Rutzen, M.D.; Peter Zloty, M.D.

Temporary Members (Voting): Natalie Afshari, M.D., FACS; Michael W. Belin, M.D., FACS; Marcia D. Carney, M.D.; Stephen S. Feman, M.D., M.P.H., FACS; Mona Johnson (Patient Representative); Joel S. Mindel, M.D., Ph.D.; M. Roy Wilson, M.D., M.S.

Acting Industry Representative to the Committee (Non-Voting): Ellen R. Strahlman, M.D., M.H.Sc. (Acting Industry Representative)

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February 27, 2012

Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee

FDA Participants (Non-Voting): Edward M. Cox, M.D., M.P.H.; Renata Albrecht, M.D.; Wiley Chambers, M.D.

Designated Federal Officer: Yvette Waples, Pharm.D.

Open Public Hearing Speaker: Mark Packer, M.D., FACS, CPI (The American Society of Cataract and Refractive Surgery)

The agenda proceeded as follows:

Call to Order and Introduction of Committee Michael Repka, M.D. Chair, DODAC

Conflict of Interest Statement Yvette Waples, Pharm.D.

Designated Federal Officer, DODAC FDA Opening Remarks Renata Albrecht, M.D.

Director, Division of Transplant and Ophthalmology Products (DTOP) Office of Antimicrobial Products (OAP) Office of New Drugs (OND), CDER, FDA

FDAPRESENTATION Wiley Chambers, M.D.

Deputy Director, DTOP, OAP, OND, CDER, FDA Clarifying Questions

BREAK

INDUSTRY PRESENTATION ISTA Pharmaceuticals, Inc.

Introduction Doral Fredericks, Pharm.D. Vice-President, Medical Affairs ISTA Pharmaceuticals, Inc. Overview of the Management and Care of

Cataract Surgery Patients

James Gow, M.D. Medical Director

ISTA Pharmaceuticals, Inc. Gordon Schooley, Ph.D. Consultant Biostatistician

Advanced Analytics and Informatics, LLC Conclusion Doral Fredericks, Pharm.D.

Vice-President, Medical Affairs ISTA Pharmaceuticals, Inc. Clarifying Questions

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LUNCH

Charge to the Committee

Questions to the Committee/Committee Discussion

ADJOURNMENT

Questions to the Committee:

1. Is it appropriate to use a single bottle of anti-inflammatory ophthalmic drops to treat both eyes post-operatively? (VOTE)

YES: 5 NO: 4 ABSTAIN: 2

Committee Discussion: The committee members who voted “Yes” expressed that for some ophthalmic surgeries, the use of a single bottle of anti-inflammatory ophthalmic drops to treat both eyes post-operatively is appropriate; however it should be at the discretion of the physician. In addition, from a patient’s point of view, the use of one bottle to treat both eyes would be more convenient and cost-effective.

The members who voted “No” expressed their concern with potential risk of cross

contamination and infection. These members noted that there is lack of evidence to support or not support whether it is safe to use a single bottle of anti-inflammatory ophthalmic drops to treat both eyes post-operatively.

The committee members who voted to “Abstain” felt the question was too vague and did not specify what type of ophthalmic surgery was being considered and/or the timing between surgeries.

Please see the transcript for details of the Committee discussion.

a. Based on the discussions that transpired, the following question was added during the meeting: Is it appropriate to label a single bottle of anti-inflammatory ophthalmic drops to treat both eyes post-operatively? (VOTE)

YES: 1 NO: 10 ABSTAIN: 0

Committee Discussion: The majority of the committee agreed that due to the lack of information, it is not appropriate to label a single bottle of anti-inflammatory ophthalmic drops to treat both eyes post-operatively. In addition, the committee commented that the decision should be left to the physician’s discretion.

Please see the transcript for details of the Committee discussion.

2. Should physician prescribing information for anti-inflammatory ophthalmic drops with post-operative indications be revised to further address infection risk? If so, please discuss what revisions would be appropriate. (DISCUSSION)

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February 27, 2012

Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee

Committee Discussion: In summary, the majority of the committee members

recommended the following revisions be made to the physician prescribing information for anti-inflammatory ophthalmic drops with post-operative indications:

Where appropriate, replace the words “eye(s)” and “sac(s)” with “affected eye”. State that the dropper or tip should not touch any surface including the eye and

adjacent tissue to prevent contamination.

State that the patient or person administering the drops wash their hands before administering.

State what to advise a patient when there is an event of possible contamination (i.e. tip touched eye).

State that single-dose containers should be opened, the drug used immediately, and the container with remaining drug discarded after use.

State that multiple dose containers should be discarded after completing the full course of treatment for the specific post-surgical indication.

If the term “sac(s)” is used, include a diagram labeling the different parts of the eye in the patient information materials.

Due to lack of conclusive evidence, the majority of the committee recommended not to include the following information in the physician prescribing information:

State that contamination could lead to infection, which could cause serious, permanent eye damage.

State that a single container should not be used to treat both eyes post-operatively (i.e., separate bottles should be used for each eye).

State that bottles with fill volumes greater than some threshold amount (e.g., approximately twice the amount of drops needed to complete the full treatment course for one eye for the post-operative indication of longest duration) should not be prescribed for patients in the post-operative setting.

Please see the transcript for details of the Committee discussion.

3. What information should be communicated to the patient to mitigate infection risk associated with post-operative use of anti-inflammatory ophthalmic drops?

(DISCUSSION)

Committee Discussion: In summary, the committee suggested the following information be communicated to the patient to mitigate infection risk associated with post-operative use of anti-inflammatory ophthalmic drops:

To avoid all contact with the tip of the bottle. To wash hands before opening the bottle.

The information communicated to the patient should be simple and succinct, include diagrams, and have large print.

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Please see the transcript for details of the Committee discussion.

4. Should carton and container labels of anti-inflammatory ophthalmic drops with post-operative indications be revised to further address infection risk? If so, how? (DISCUSSION)

Committee Discussion: The committee members suggested the following revisions to the carton and container labels of anti-inflammatory ophthalmic drops with post-operative indications:

Include “Do not touch eye or any surface with tip”

Designating “right eye” and “left eye” with markings on the bottle itself to allow the physician (or pharmacy) to check off which eye to administer the medication Please see the transcript for details of the Committee discussion.

5. Please comment on the appropriate fill volume for anti-inflammatory ophthalmic drops indicated for post-operative use. (DISCUSSION)

Committee Discussion: Overall, the committee members are in favor of increasing the fill volume for anti-inflammatory ophthalmic drops indicated for post-operative use. The committee acknowledged the importance of having a fill volume large enough to

account for spillage and to accommodate a physician’s flexibility to increase frequency and/or duration. In addition, some members recommended that the fill volume should be based on stability and what is marketable for the intended duration. The committee members also acknowledged the larger fill volume would ease the burden of patients having to purchase an additional bottle. Please see the transcript for details of the Committee discussion.

6. Please comment on the advantages and disadvantages of packaging anti-inflammatory ophthalmic products for post-operative use together in a twin pack or dual pack configuration. Please comment on what additions or revisions to packaging and

labeling would be appropriate to ensure that twin pack or dual pack products are safe for their intended use. (DISCUSSION)

Committee Discussion: The committee did not comment on the advantages and

disadvantages of packaging anti-inflammatory ophthalmic products for post-operative use together in a twin pack or dual pack configuration. However, one committee

member stated that there is no difference in prescribing a twin pack versus two separate bottles. It was also noted that packaging is often not sent home with the patient as only the actual bottle is provided.

The committee members suggested the following additions to the packaging and labeling of a twin pack or dual pack:

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February 27, 2012

Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee

Designating “right eye” and “left eye” markings on the bottle itself to allow the physician to check off which eye to administer the medication.

Standardization across all ophthalmic drops (proprietary and generic) to have the same color bottle cap indicating for use in the right eye and a different bottle cap color designated for use in the left eye.

Please see the transcript for details of the Committee discussion. The meeting was adjourned at approximately 2:30 p.m.

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