-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.

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.