"We believe the statistical significance observed in both trials at month 33 meets the criteria for replication of efficacy in the two studies," said Susan Caballa, senior vice president of regulatory affairs at Alimera. "We will provide this safety and efficacy data to the FDA so that it will have the opportunity to review it as part of our pending NDA for ILUVIEN for the treatment of DME."
Note to Investors
Alimera will host a conference call today, February 3, at 4:30 p.m. ET to discuss these results in greater detail. The conference call will be hosted by Dan Myers, president and chief executive officer, Ken Green, chief scientific officer, and Rick Eiswirth, chief operating officer and chief financial officer. To participate in the call, please dial (877) 369-6586 (U.S. and Canada) or (253) 237-1165 (international). A live webcast will be available on the Investor Relations section of the corporate website at http://www.alimerasciences.com .
A replay of the conference call will be available beginning February 4, 2011 at 11:30 a.m. ET and ending on February 18, 2011, and can be accessed by dialing (800) 642-1687 (U.S. and Canada) or (706) 645-9291 (international), Conference ID Number: 34501644.Slides from the conference call containing more detailed information with respect to the 36-month data are being furnished by Alimera to the Securities and Exchange Commission on Form 8-K. The information in this press release is qualified in its entirety by the more detailed information contained in those slides. Additional data and analysis of the FAME Study will be presented by Peter Campochiaro, M.D., on February 12, 2011, at 1:40 p.m. at the Angiogenesis, Exudation and Degeneration 2011 Meeting in the Mandarin Oriental Hotel, Miami, Fla. Dr. Campochiaro is a professor in the Department of Ophthalmology at The Wilmer Eye Institute, Retina Division at Johns Hopkins.