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Print Edition StoriesThursday, March 12, 2009
PSivida posts positive results from eye implant study
By Mass High Tech Staff
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Watertown-based biotech company pSivida Corp. reports good news at the 12-month point for both safety and effectiveness for Iluvien, its implantable treatment of diabetic macular edema.
Iluvien is an insert containing the corticosteroid, fluocinolone acetonide, that goes into the eye of someone with diabetic macular edema, a disease which causes progressive loss of sight.
According to pSivida (Nasdaq: PSDV), the 36-month, Phase 2 study had 20 patients on a low dose of Iluvien and 17 patients on a higher dose. No patients on the lower dose reported increased pressure in the eye, and 23.5 percent of those in the higher dose group reported some increased pressure, with one requiring surgery. pSivida points out that those figures compare to the insert using the same active compound from Bausch & Lomb Inc. which has even higher doses and resulted in 35 percent of patients feeling greater pressure in the eye. Baush & Lomb’s product, Retisert, is approved by the U.S. Food and Drug Administration for a different eye condition.
Among high dose patients, 27.3 percent had an improvement in visual acuity of 15 letters or greater over a baseline result, and 23.1 percent of the low dose patients had an improvement of 15 letters or greater, according to the company.
Last month, pSivida named board member Paul Ashton as its president and CEO. Ashton came to the company December 2005 after pSivida’s acquisition of his company Control Delivery Systems. He played a strong role in moving the company from Australia, where it was founded, to Watertown last year.
For fiscal 2008, pSivida posted a loss of $75.7 million on revenue of $3.5 million.
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