Alimera Sciences Inc., which specializes in drug treatments for the eyes, said Friday it filed a new request for marketing approval of its drug candidate Iluvien, designed to treat an eye disease that affects diabetes patients.
Alimera said it filed its application on Thursday, and the Food and Drug Administration will take six months to review the submission. The new filing includes a third year of safety and effectiveness data on Iluvien, as well as information about manufacturing, packaging and sterilization.
Iluvien is intended to treat diabetic macular edema. The FDA declined to approve the drug in December, saying it wanted another year of data in addition to the two years' worth Alimera had provided. The agency also cited problems with third-party manufacturers. Alimera said it believes those issues have been resolved.
Iluvien was developed by pSivida Inc. of Watertown, Mass., and licensed to Alimera.
If the FDA approves the drug, Alimera will pay pSivida $25 million, and pSivida will receive 20 percent of the net profit on sales.
Shares of Alpharetta, Ga.-based Alimera fell 5 cents to $8.35 in afternoon trading.
Shares of pSivida remained around $3.88 in afternoon trading Friday.