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Alimera Announces Positive Results From the Two Phase 3 FAME(TM) Trials of Iluvien(R) in Patients With Diabetic Macular Edema
Date:12/23/2009

mera announced that it had closed an extension of its Series C financing in which it issued shares of its Series C preferred stock and warrants to purchase shares of its Series C preferred stock. By their terms, the warrants were to be exercised in full within 30 days of the delivery of top line data from the Company's Phase III trials for Iluvien. Today, Alimera announced that it had received written notice from its principal warrant holders of their election to exercise the warrants. This warrant exercise, which will result in $10 million in proceeds to Alimera, will close in January 2010.

About the FAME Study

The Phase 3 FAME Study consists of two multi-center, randomized, double-masked trials for Iluvien in sites across the United States, Canada, Europe and India. The two trials have identical protocols and enrolled 953 patients across 101 academic and private practice centers. Patients in each trial were randomly assigned to one of three groups in a 2:2:1 randomization, respectively. One group received a high dose of Iluvien (an approximate initial 0.45 micrograms per day dose), a second received a low dose of Iluvien (an approximate initial 0.23 micrograms per day dose) and the third group (control) received sham. The sham included all the steps involved in the insertion procedure with the exception that patients in this group had a blunt inserter without a needle to apply pressure to the anesthetized eye in order to simulate an insertion. This procedure mimics an intravitreal insertion and helps to maintain proper patient masking.

About DME

DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifest
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SOURCE Alimera Sciences, Inc.
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Related medicine technology :

1. Alimera Sciences Announces Presentation of Data From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study at ARVO 2009 Annual Meeting
2. Alimera Sciences Iluvien(TM) Phase 3 Studies for DME Pass Final DSMB Review Prior to October Readout
3. Alimera Reports Favorable Safety and Efficacy Results From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study
4. Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study
5. DSMB Again Supports Continuation of Alimera Sciences Phase 3 Clinical Trial of Iluvien(TM) for the Treatment of DME
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