ThromboGenics' ocriplasmin misses in wet AMD trial

ThromboGenics N.V. (Euronext:THR) disclosed in a business update for the period ending April 30 that ocriplasmin missed the primary endpoint in the Phase IIa MIVI-5 trial to treat focal vitreomacular adhesion (VMA) associated with wet age-related macular degeneration (AMD). Specifically, a single injection of ocriplasmin plus anti-VEGF treatment missed the primary endpoint of a greater proportion of patients achieving complete resolution of their focal VMA at day 28 vs. sham control plus anti-VEGF treatment (24% vs. 12%, p=0.26). ThromboGenics said it is discussing future development plans for ocriplasmin in the indication with the Alcon Inc. ophthalmic unit of Novartis AG (NYSE:NVS; SIX:NOVN), which has ex-U.S. rights to commercialize the recombinant microplasmin, a truncated form of the natural human protein plasmin.

Ocriplasmin is approved in the EU to treat vitreomacular traction, including when associated with a macular hole of 400 µm or less in diameter; and in the U.S. to treat symptomatic VMA, which causes vitreomacular traction. ThromboGenics, which launched the drug in the U.S. in mid-January, also reported U.S. sales of over $10 million through the end of April for Jetrea. Novartis launched ocriplasmin in the EU this quarter. ...