FDA grants pSivida, Alimera expedited review for macular degeneration therapy

FDA grants pSivida, Alimera expedited review for macular degeneration therapy
August 31, 2010 by MassDevice staff

pSivida Corp. and Alimera Sciences win priority review status for their Iluvien drug/device combination, designed to treat diabetic macular degeneration.
PSDV, ALIM logos

The Food & Drug Administration put pSivida Corp. (NSDQ:PSDV) and Alimera Sciences Inc. (NSDQ:ALIM) on the fast track, granting an expedited review for their drug/device combination designed to treat diabetic macular edema.

Watertown, Mass.-based pSivida and Alpharetta, Ga.-based Alimera filed a new drug application with the FDA in June for Iluvien, a sustained release drug delivery system that delivers flucocinolone acetonide, a steroid, for the treatment of DME.

The federal watchdog agency granted priority review status to the application, moving the goal for finishing the review from 10 months back to six months.

That means a response could drop during the fourth quarter, pSivida president and CEO Dr. Paul Ashton said in prepared remarks, adding that FDA approval would trigger a $25 million milestone payment from Alimera.

The milestone payment wouldn't be the first time Alimera ponied up for pSivida. Its $72 million IPO in April triggered the repayment of a $15 million loan and $225,000 in interest. The companies are seeking European approval for Iluvien. If it makes it to market, pSivida will collect 20 percent of the net profits.

The FDA has already cleared a pair of pSivida products: Retisert, for the treatment of posterior uveitis, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc. The company is also developing other ophthalmic products with Pfizer Inc. (NYSE:PFE), its largest shareholder, and has products of its own in the pipeline outside of ophthalmology, according to a press release.

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