ThromboGenics Announces EMA Acceptance for Review of Marketing Authorisation Application for Ocriplasmin

20-Oct-2011 - Belgium

ThromboGenics NV announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for ocriplasmin (2.5 mg/ml, solution for injection) for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.

The ocriplasmin MAA will be evaluated through the EMA’s Centralised Procedure with an official start date of October 19, 2011. If approved, ocriplasmin will gain marketing authorisation for all EU Member States simultaneously.

Symptomatic VMA is a progressive condition that if left untreated generally leads to retinal distortion, further decrease in vision and has potential for irreversible damage and complications. Market surveys conducted by ThromboGenics suggest that there are approximately 500,000 patients annually in the major markets of the EU and the US who could potentially benefit from ocriplasmin.

Dr Patrik De Haes, ThromboGenics’ CEO, said: “The global ThromboGenics team is proud to have achieved the successful acceptance for review of the European MAA for ocriplasmin, a major corporate milestone. Ocriplasmin is also expected to be filed with the FDA in the U.S. by the end of the year. If approved, ocriplasmin will be the first pharmacological treatment for a condition that is currently only treated via surgery, and only after the patient’s vision has significantly deteriorated.

“We are continuing to make excellent progress in building our commercial organisation in order to educate and support the retina specialist community, with the aim of ensuring ocriplasmin achieves its full therapeutic potential and delivers maximum benefit to patients.”

https://www.bionity.com/en/news/134912/thrombogenics-announces-ema-acceptance-for-review-of-marketing-authorisation-application-for-ocriplasmin.html