8:30 A.M. – 3:30 P.M.

Hilton Washington DC North/Gaithersburg

Salons A, B, and C

620 Perry Parkway

Gaithersburg, MD

8:30 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

8:45 - 9:15 OPEN PUBLIC HEARING

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

9:15 - 10:15 SPONSOR PRESENTATION

10:15 - 10:30 Panel Questions for the Sponsor

10:30 - 10:45 FDA PRESENTATION

James Saviola, O.D. – Introduction

Eleanor McGhee – Team Leader

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

10:45 - 11:00 Panel Questions for FDA

11:00 - 11:15 Additional Comments From the Sponsor

11: 15 - 11:45 COMMITTEE DELIBERATIONS

Primary Panel Reviewers: Timothy T. McMahon, O.D.

Timothy B. Edrington, O.D.

11:45 - 12:45 LUNCH

12:45 PM PANEL DISCUSSION OF P870024/S043

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

3:30 PM OPEN MEETING ADJOURNED