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FDA grants priority review for ocriplasmin intravitreal injection

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ThromboGenics announced that the U.S. Food and Drug Administration has accepted its biologics licensing application for ocriplasmin intravitreal injection and granted it priority review, according to a news release.

The company has completed two phase 3 trials of ocriplasmin 2.5 mg/mL for the treatment of symptomatic vitreomacular adhesion including macular hole, the proposed indication in the biologics licensing application.

“The Company is happy that the FDA has granted ocriplasmin priority review,” Dr. Patrik De Haes, CEO of ThromboGenics, said in the release. “We are looking forward to our discussions with the FDA as we work to make ocriplasmin available to the many patients in the U.S. that could benefit from this novel treatment option.”

The ocriplasmin licensing application will be discussed at an FDA advisory committee meeting scheduled for July 26. The committee will also discuss a supplement to the biologics licensing application for Lucentis (ranibizumab, Genentech) at the meeting.