ATLANTA, Aug. 12, 2010 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc., (Nasdaq:ALIM), ("Alimera"), today announced financial results for the second quarter ended June 30, 2010 and provided an update on progress toward achieving its 2010 goals.
"We are pleased that we successfully achieved our regulatory submission goals for our lead product candidate, Iluvien® for the treatment of diabetic macular edema (DME). On the 28 th of June, we submitted a New Drug Application to the U.S. Food and Drug Administration (FDA). We have requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of this year," said Dan Myers, President and Chief Executive Officer of Alimera. "Assuming a positive response from the FDA, we anticipate launching Iluvien® as early as the first quarter of 2011."
"We submitted Iluvien to European regulatory authorities for the treatment of DME during the week of July 5 th. A Marketing Authorization Application (MAA) was presented to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and applications have been submitted to Austria, France, Germany, Italy, Portugal and Spain," said Mr. Myers.There are currently no ophthalmic drug therapies approved in the United States for the treatment of DME. Alimera estimates that there are more than 300,000 new cases of DME annually and data shows that diabetic retinopathy causes 12,000 to 24,000 new cases of blindness each year in the United States alone. The Company estimates that the addressable market for Iluvien® could reach $1 billion per year. Financial Highlights Net loss for the quarter ended June 30, 2010 was $4.8 million, or $0.20 per common share, compared with a net loss of $8.1 million, or $5.46 per common share, for the quarter ended June 30, 2009. Included in Alimera's results for the second quarter of 2010 was a gain of $380,000 associated with the decrease in the fair value of the conversion feature of Alimera's preferred stock, compared with an expense of $1.1 million recognized in the second quarter of 2009 in connection with an increase in the fair value of the preferred stock conversion feature. The changes in fair value are primarily attributable to changes in the estimated fair value of Alimera's common stock. In connection with the Company's IPO in April 2010, all of its preferred stock was converted to common stock and the liability associated with the conversion feature of its preferred stock was eliminated.