Biopharmaceutical company Outlook Therapeutics Inc (Nasdaq:OTLK) said on Friday that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for ONS-5010/LYTENAVA (bevacizumab gamma) as a treatment for wet age-related macular degeneration (wet AMD) in the European Union.
This opinion paves the way for potential authorisation from the European Commission (EC) within approximately 67 days.
The CHMP's decision was based on results from Outlook Therapeutics' wet AMD clinical programme, including the NORSE ONE, NORSE TWO and NORSE THREE trials, as well as supporting studies and literature.
Upon approval, ONS-5010 is expected to receive 10 years of market exclusivity in the EU. The EC's decision will automatically apply across all 27 EU Member States, and subsequently to Iceland, Norway and Liechtenstein within 30 days.
Outlook Therapeutics is evaluating options for both direct commercialisation and partnership opportunities in Europe on a country-specific basis.
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