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ISELIN, N.J. – Outlook Therapeutics, Inc. (NASDAQ:) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its investigational ophthalmic formulation of bevacizumab, known as ONS-5010/LYTENAVA™. This endorsement is a crucial step towards potential European Commission (EC) authorization for the treatment of wet age-related macular degeneration (wet AMD (NASDAQ:)).
The CHMP’s favorable opinion is based on data from three completed registration clinical trials – NORSE ONE, NORSE TWO, and NORSE THREE – as well as additional studies and supporting literature. If the EC grants approval, which is anticipated within 67 days from the CHMP’s recommendation, ONS-5010/LYTENAVA™ could enjoy ten years of market exclusivity in the EU for the treatment of wet AMD.
Russell Trenary, President and CEO of Outlook Therapeutics, expressed pride in the company’s progress, stating that the CHMP’s positive opinion brings them closer to offering the EU market the first and only on-label, ophthalmic bevacizumab for wet AMD treatment.
ONS-5010/LYTENAVA™ is designed as an intravitreal injection for wet AMD and other retinal diseases. Currently, no FDA or EC-approved ophthalmic formulations of bevacizumab are available, leading clinicians to rely on repackaged intravenous bevacizumab from compounding pharmacies, which carries risks of contamination and inconsistent potency. Approval of ONS-5010/LYTENAVA™ would provide a standardized treatment option.
Bevacizumab, the active ingredient in ONS-5010/LYTENAVA™, is a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), thereby reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina following intravitreal injection.
The EC’s decision, once made, will automatically apply to all 27 EU Member States and, within 30 days, to Iceland, Norway, and Liechtenstein.
Outlook Therapeutics aims to achieve approval for its ophthalmic formulation of bevacizumab in various markets, including the United States and Japan, besides the EU. The company is also exploring direct commercialization and partnership opportunities in Europe on a country-by-country basis.
This news report is based on a press release statement from Outlook Therapeutics, Inc.
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