9:30 A.M. – 5 P.M.

Hilton Washington DC North/Gaithersburg

Salons A, B, and C

620 Perry Parkway

Gaithersburg, MD

9:30 AM Call to Order Jayne S. Weiss, M.D. - Acting Chair

Introductory Remarks Sara M. Thornton - Executive Secretary

Conflict of Interest Statement

Appointment to Temporary Voting Status

9:45 - 10:15 OPEN PUBLIC HEARING

Jayne S. Weiss, M.D., Acting Chair

10:15 - 10:30 BRANCH UPDATES

Donna R. Lochner

Chief, Intraocular and Corneal Implants Branch

10:30 - 11:30 SPONSOR PRESENTATION

11:30 - 11:45 Panel Questions for the Sponsor

11:45 - 12 Noon FDA PRESENTATION

Donna Lochner – Introduction

Joel P. Glover – Team Leader

Bernard L. Lepri, O.D., M.S., M.Ed. - Clinical Reviewer

12 Noon – 12:15 PM Panel Questions for FDA

12:15 - 12:20 Additional Comments From the Sponsor

12:20 - 1:20 LUNCH

1:20 COMMITTEE DELIBERATIONS

Primary Panel Reviewers: Joel Sugar, M.D.

Woodford S. Van Meter, M.D.

PANEL DISCUSSION OF P010059

to include FDA questions to the Panel

30-MINUTE OPEN PUBLIC HEARING SESSION

FDA – CLOSING COMMENTS (5 minutes)

SPONSOR – CLOSING COMMENTS (5 minutes)

Voting Options Read

PANEL RECOMMENDATION TAKEN BY VOTE

POLLING OF PANEL VOTES

COMMENTS FROM CONSUMER AND INDUSTRY REPRESENTATIVES

FINAL PANEL COMMENTS