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June 7, 2012 /PRNewswire/ --
Meeting scheduled for
26 July 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.
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.
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. More information is available at
Important information about forward-looking statements