Outlook Therapeutics Inc ( OTLK ) shares are trading higher after the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion concerning the authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for wet age-related macular degeneration (wet AMD).

The shares are trading higher on a strong session volume of 4.485 million compared to an average volume of 160.790K, as per data from Benzinga Pro.

Outlook Therapeutics ( OTLK ) is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

Related: This Analyst Upgrades Vision Disorder-Focused Outlook Therapeutics’ Prospects After FDA Agreement Despite Investor Concerns.

The CHMP positive opinion was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO, and NORSE THREE. 

If approved, an initial ten years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA.

Last year, Outlook Therapeutics ( OTLK ) completed the requested Type A Meetings with the FDA to discuss the Complete Response Letter (CRL).

The company received the letter in August regarding the Biologics License Application (BLA) for ONS-5010.

The FDA informed Outlook Therapeutics ( OTLK ) that an additional adequate and well-controlled clinical trial would be required to approve ONS-5010 for wet AMD.

ONS-5010/LYTENAVA is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for wet AMD and other retinal diseases. 

Price Action: OTLK shares are up 36.40% at $9.61 on the last check Friday.