The FDA issued a third complete response letter for ONS-5010/Lytenava, requesting confirmatory efficacy evidence for wet AMD treatment. Lytenava is an ophthalmic bevacizumab formulation, potentially ...

The FDA said it cannot approve the application in its present form for the treatment of wet age-related macular degeneration.

The ONS-5010 BLA resubmission was supported by data from the NORSE programme, including NORSE TWO and other trials.

Please provide your email address to receive an email when new articles are posted on . Home OCT may help patients achieve extended dosing intervals through consistent fluid evaluation. Scans are ...

The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...

Please provide your email address to receive an email when new articles are posted on . One specialist argued that, in the future, gene therapy technologies will be the favored option for wet AMD.

In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab ...

Oraya Therapeutics, Newark, Calif.-based minimally invasive ophthalmic treatment company, has published the results of a study analyzing the effectiveness and safety of its wet age-related macular ...

Clearside Biomedical, Inc. announced on March 20, 2025, that it presented findings on its lead clinical program, CLS-AX, a suprachoroidal injectable suspension of axitinib, at the 2025 Wet AMD & ...

This is a quickly progressing field, according to Sarju Patel, MD, attending physician at Retinal Consultants of America. He has high expectations that advances from subtly tinted eyeglass lenses to ...

WATERTOWN, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of ...

Ocular Therapeutix Inc. (NASDAQ:OCUL) is a biopharmaceutical company that develops and commercializes therapies for retinal ...