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Outlook Eyes Blockbuster-Sized Sales For An Old Eye Drug In Wet-AMD

 
• By Jessica Merrill

The company is seeking FDA approval for a first-time ophthalmic formulation of bevacizumab and also refiled its BLA.

eye
Outlook refiled a BLA for bevacizumab for wet-AMD • Source: Shutterstock

Outlook Therapeutics, Inc. believes it has a straightforward commercial opportunity on its hands if it can become the first to win US Food and Drug Administration approval for an ophthalmic formulation of bevacizumab, even though the VEGF inhibitor has long seen off-label use to treat wet age-related macular degeneration (AMD) and other retinal diseases, and the market is already highly competitive.

The company announced on 30 August that it has re-filed a biologics license application (BLA) for its bevacizumab formula ONS-5010,...

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• By Manas Mishra

Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 
• By Sushmita Panda

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 
• By Sushmita Panda

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
• By Kevin Grogan

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

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Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 
• By Alexandra Shimmings

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
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The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Sanofi’s Sarclisa Wins Another EU Multiple Myeloma Nod In Its Unequal Battle With J&J’s Darzalex

 
• By Sushmita Panda

The French drugmaker's anti-CD38 antibody has racked up another approval in first-line multiple myeloma, but it marks a small victory while the company develops a subcutaneous version to help level the field with J&J’s Darzalex.