• Member Login
• Sitemap
• Contact
• RSS feed

ThromboGenics Receives Notice from FDA of Advisory Committee Meeting for Ocriplasmin

07/06/2012

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) has notified the Company that its new biologic license application (BLA) for ocriplasmin intravitreal injection will be discussed at the Dermatologic and Ophthalmic Drugs Advisory Committee scheduled for July 26, 2012.

Ocriplasmin is an investigational biological drug candidate intended for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.

ThromboGenics resubmitted its BLA for ocriplasmin in April 2012 in anticipation of it being granted Priority Review by the FDA.

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The company’s lead product, ocriplasmin, has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole. The MAA for ocriplasmin has been accepted for review in Europe and the BLA has been re-submitted in the U.S. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.

In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments, plus an attractive level of royalties on Alcon’s net sales of ocriplasmin. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for a number of new vitreoretinal indications.

ThromboGenics is also developing TB-403, a novel antibody therapeutic, in collaboration with BioInvent International, for cancer and non-cancer, including ophthalmology, indications.

ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR.

Source: ThromboGenics