FDA Advisory Committee Recommends ThromboGenics? Ocriplasmin for the Treatment of Symptomatic Vitreomacular Adhesion (VMA)
- Category: Proteins and Peptides
- Published on Friday, 27 July 2012 14:45
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ThromboGenics to hold conference call to discuss the panel recommendation
LEUVEN, Belgium I July, 27, 2012 I ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion (VMA). The Committee voted 10 to 0 at its meeting held yesterday that the benefits of administering ocriplasmin for the treatment of vitreomacular adhesions outweigh the potential risks.
The recommendation of the Advisory Committee will form part of the FDA?s overall assessment of the ocriplasmin Biologics License Application (BLA). The FDA has assigned the ocriplasmin BLA a Prescription Drug User Fee Act (PDUFA) goal date of 17 October, 2012.
Dr Patrik De Haes, ThromboGenics? CEO, said: ?We are pleased that the Advisory Committee has made a positive recommendation supporting the approval of ocriplasmin for the treatment of symptomatic VMA. We will continue to work with the FDA as it completes its assessment of the ocriplasmin BLA. 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 U.S. who could benefit.?
Symptomatic VMA is a progressive condition that if left untreated frequently leads to retinal distortion, further deterioration in vision and has the potential to cause irreversible damage and complications. Market surveys conducted by ThromboGenics suggest that there are approximately 500,000 patients in the U.S. and the major markets of the EU who could potentially benefit from ocriplasmin annually. If approved, ocriplasmin will be the first pharmacological treatment for symptomatic VMA.
A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO of ThromboGenics, on Friday, 27 July at 15:00 CET (09:00 ET).