Investor Alert

July 19, 2012, 9:42 a.m. EDT

FDA OKs pSivida uveitis drug for Phase III trials

By Chelsea Stevenson

pSivida Corp. received clearance from the U.S. Food and Drug Administration to move to Phase III trials for its investigational new drug that treats a blinding disease with the company's injectable micro-insert.

Shares soared 9.8% to $2.35 in premarket trading. The stock has surged 93% year to date.

pSivida's two clinical trials will treat 300 patients with posterior uveitis. The administration has allowed the company to bypass Phase I and Phase II trials. The administration also agreed the trials be recurred within 12 months so the company can reference as much data as possible. Additional clinical safety data pertinent to the drug were conducted by the company's partner Alimera Sciences Inc. (ALIM) for a drug which treats Diabetic Macular Edema.

Posterior uveitis is an inflammatory disease of one of the layers in the eye. In the U.S. approximately 75,000 people are affected by the disease. The micro-insert used to treat the disease is a tiny tube that releases steroid flucionlone acetoniade at a constant rate for about three years. The injection occurs during an office visit.

In May, the company saw improved results from its Iluvien drug for the treatment of diabetic macular edema. The drug began to receive international recognition.

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