Outlook Positive CHMP Opinion for ONS-5010 for Wet AMD

 

• Positive opinion serves as a basis for final decision for potential authorization from the European Commission (EC), expected within 67 days
  

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the authorization of ONS-5010/LYTENAVA™ (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) in the EU. Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

https://www.globenewswire.com/news-release/2024/03/22/2850893/0/en/Outlook-Therapeutics-Receives-European-Union-Positive-CHMP-Opinion-for-ONS-5010-as-a-Treatment-for-Wet-AMD.html