pSivida surges on Medidur data

Psivida (NSDQ:PSDV) shares surged today after the company said its Medidur drug-device combination met the primary endpoints in a Phase III clinical trial for treating posterior uveitis. Medidur uses the same injectable implant and drug as the Iluvien drug-device combo pSivida licensed to Alimera Sciences (NSDQ:ALIM) for treating diabetic macular degeneration. Iluvien won FDA approval in September 2014. Like Iluvien, Medidur is designed to release the corticosteroid flucinolone acetonide over3 years after being implanted in the back of the eye. Watertown, Mass.-based pSivida said the 129-patient, randomized and double-blinded trial met the primary efficacy endpoint, prevention of recurrence of disease, after 6 months. Patients in the Medidur arm showed an 18.4% recurrence rate, compared with 78.6% of the sham arm. The treatment arm also showed a 27.6% rate of increased intraocular pressure above 21 mmHg for at least 1 observation, 10.9% more than the 16.7% rate for the control group. That difference was reduced to 6.1% after the most recent follow-up visits, some of which were as long as 24 months out, pSivida said. Through 6 months, 2.3% of Medidur-treated eyes needed an incisional procedure to reduce IOP, compared with no control eyes. Through the most recent follow-up, 3.4% of Medidur-treated eyes compared to 2.4% of control eyes required an incisional procedure to reduce IOP, the company said. “The results of this Phase III trial are extraordinary. With ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Optical/Ophthalmic Drug-Device Combinations Clinical Trials pSivida Corp. Source Type: news