Outlook Therapeutics, Inc. (OTLK) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has given a positive opinion on the approval of a new ophthalmic formulation of bevacizumab called ONS-5010/Lytenava also known as 'bevacizumab gamma.'
This new formulation is specifically designed to treat wet age-related macular degeneration or wet AMD in the European Union.
The CHMP's positive opinion was influenced by the outcomes of Outlook Therapeutics' wet AMD clinical program for ONS-5010, which included three successful registration clinical trials.
If authorized, ONS-5010 is anticipated to receive ten years of exclusive market rights in the European Union.
The company stated that it is also exploring direct sales and partnerships in Europe.
A decision from the European Commission is expected around 67 days after the CHMP opinion.
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