Eyeing Solo U.S. Debut, EU Biotech ThromboGenics Preps Ocriplasmin For Launch
Small European biotechs usually build their business in their home region first, and later look to the US for growth. Belgium's ThromboGenics is doing the opposite; it aims to launch its lead product initially in the US, and will tackle Europe after partner and market leader Alcon paves the way.
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FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 10-0 that the risk-benefit ratio of ocriplasmin for vitreomacular adhesions is positive, and 6-3 that no additional pre-approval studies are needed.
ThromboGenics will seek to convince the Dermatologic and Ophthalmic Drugs Advisory Committee that further safety studies should not be made a condition of approval of its ocriplasmin for symptomatic vitreomacular adhesion, including macular hole.
Novartis' ophthalmic unit Alcon will collaborate with Belgium's ThromboGenics on the marketing and future development of the vitreomacular adhesion therapy, ocriplasmin.