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Reiterates Positive 36-Month Results From the Completed Phase 3 FAME™ Study of ILUVIEN® in Patients With Diabetic Macular Edema
Cash, Cash Equivalents and Investments at December 31, 2010 Totaled $54.8 Million
ATLANTA, Feb. 10, 2011 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc., (Nasdaq:ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced financial results for the fourth quarter and year ended December 31, 2010.
"Our recently released 36-month data showed a consistent response rate of patients whose best corrected visual acuity improved by 15 or more letters from baseline at month 24 and month 36, with a peak rate of 31.4% in month 30. We believe these data demonstrate that ILUVIEN® can provide a long-term option for the treatment of diabetic macular edema (DME), for up to three years, and we look forward to continuing to work with the FDA toward the approval of ILUVIEN for the treatment of DME," said Dan Myers, president and chief executive officer of Alimera. "During the fourth quarter of 2010, we increased our pre-marketing budget in preparation for the commercial launch of ILUVIEN previously expected in the first half of 2011. Our team has many years of experience launching new pharmaceutical products and we are confident in our go-to-market strategy for a potential introduction later this year."
Alimera received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in the latter half of December 2010. The FDA issued the CRL to communicate its decision that the New Drug Application (NDA) for the investigational drug ILUVIEN could not be approved in its present form.
The NDA included data through month 24 of the study. No new clinical studies were requested by the FDA in the CRL. However, the FDA asked for analyses of the safety and efficacy data through the end of the FAME™ Study to further assess the relative benefits and risks of ILUVIEN. Alimera is currently preparing the analyses the FDA requested having completed the FAME Study and publicly released data on February 3, 2011. The FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN, which Alimera is in the process of compiling.