Managed Healthcare Executive

FDA issues third rejection of bevacizumab to treat wet AMD

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 ...
Seeking Alpha

4D Molecular Therapeutics Advances Wet AMD Treatment Paradigm

4D Molecular Therapeutics' gene therapy, 4D-150, shows potential to reduce the treatment burden for patients with severe wet AMD. Interim findings from a Phase 2 trial demonstrate up to an 89% ...
Pharmaceutical Technology on MSN

Outlook Therapeutics receives FDA response on ONS-5010 for wet AMD

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

FDA Denies Approval of Outlook Therapeutics' ONS-5010 BLA: Key Takeaways

A complete response letter is a formal communication from the FDA indicating that an application cannot be approved in its present form. In the case of Outlook Therapeutics, the FDA noted that while ...
GEN

Wet AMD Treatments Could Work Better If Both VEGF and ANGPTL4 Are Targeted

Researchers led by a team at the Wilmer Eye Institute, Johns Hopkins Medicine, have discovered why vision in some patients with neovascular (nv) or “wet” age-related macular degeneration (nvAMD, or ...
Seeking Alpha

Outlook Therapeutics: Poised To Jump With Wet AMD Treatment If It Can Overcome FDA Hurdles

Outlook Therapeutics faces liquidity issues and delays in FDA approval for its Wet AMD therapy, leading to a downgrade from Strong Buy to Buy. The potential blockbuster market for LYTENAVA in treating ...

Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of 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 ...
Nasdaq

Outlook Therapeutics Announces NICE Recommendation for LYTENAVA™ in Wet AMD Treatment

Outlook Therapeutics, Inc. has announced a key development in the treatment of wet age-related macular degeneration (wet AMD) with the National Institute for Health and Care Excellence (NICE) ...
Science Daily

Why some patients don't respond well to wet macular degeneration treatment

A new study explains not only why some patients with wet age-related macular degeneration (or 'wet' AMD) fail to have vision improvement with treatment, but also how an experimental drug could be used ...
Nasdaq

EyePoint Completes Enrollment in Pivotal Phase 3 LUGANO Trial of DURAVYU™ for Treatment of Wet Age-Related Macular Degeneration

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 ...
MM&M

EyePoint Pharmaceuticals’ wet AMD therapy hit primary endpoint in Phase 2 trial

EyePoint Pharmaceuticals’ investigational therapy for wet age-related macular degeneration (wet AMD) was effective in a Phase 2 trial, the company announced Monday. The announcement was welcome news ...