Belgian drug-maker ThromboGenics NV announced last Friday that it and ex-U.S. partner Novartis (NYSE:NVS) received a nod of approval from an FDA advisory panel investigating its ocriplasmin treatment for symptomatic Vitreomacular Adhesion (VMA). The treatment, a single injection that would be the first of its kind, improves on the surgical standard of care in treating VMA. The FDA advisory panel said that the benefits of administering ocriplasmin outweigh the risks and advised for approval; ocriplasmin has a PDUFA date of October 17th. The EMA is also reviewing ocriplasmin for approval in the European Union.
Novartis owns licensing of ocriplasmin for all markets outside of the U.S., and ThromboGenics suggests a 500,000 patient market in the U.S. and EU alone. Expect a small run-up in share price into the PDUFA date for NVS with this positive news, however as ex-U.S. licensee, NVS may see less of the excitement than its Brussels-exchanged partner.