Ocriplasmin (ThromboGenics) should be approved for the treatment of symptomatic vitreomacular adhesion (VMA), according to a unanimous recommendation to the FDA by its Dermatologic and Ophthalmic Drugs Advisory Committee.
Silver Spring, MD-Ocriplasmin (ThromboGenics) should be approved for the treatment of symptomatic vitreomacular adhesion (VMA), according to a unanimous recommendation to the FDA by its Dermatologic and Ophthalmic Drugs Advisory Committee.
The agency is expected to make a decision regarding the biologics license application (BLA) for the drug by Oct. 17.
“We will continue to work with the FDA as it completes its assessment of the ocriplasmin BLA,” said Patrik De Haes, MD, chief executive officer of ThromboGenics. “Symptomatic VMA is an area of unmet medical need, and ThromboGenics is looking forward to making this novel treatment option available to the many patients in the United States who could benefit.”
If approved, ocriplasmin will be the first pharmacologic treatment for symptomatic VMA. Annually, about 500,000 patients in the United States and the major markets of the European Union could potentially use ocriplasmin, according to the company’s market research.
Ocriplasmin (microplasmin) is a truncated form of the human serine protease plasmin that retains its enzymatic properties, according to information posted on the company’s Web site. The small molecule is designed specifically for use in the eye and is believed primarily to target the fibronectin, laminin, and type IV collagen fibers that adhere the vitreous to the retina. Ocriplasmin is delivered via an intravitreal injection.
In March, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for several vitreoretinal indications. ThromboGenics retains all U.S. rights.
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