Outlook Therapeutics completes enrollment in ONS-5010/Lytenava safety study
Outlook Therapeutics has completed patient enrollment in a planned open-label safety study of ONS-5010/Lytenava 3 months ahead of schedule, according to a press release.
One hundred ninety-five subjects with retinal diseases that can be treated with anti-VEGF options will receive three monthly intravitreal doses of ONS-5010/Lytenava (bevacizumab-vikg). The study data will be used to support a biologics license application for wet age-related macular degeneration in 2021, according to the release.
“The expedited manner in which enrollment was completed strengthens our confidence that an FDA-approved ophthalmic formulation of bevacizumab represents a significant unmet need in the ophthalmic community,” Mark Humayun, MD, PhD, medical advisor to Outlook Therapeutics, said in the release.
If approved, ONS-5010/Lytenava would be the first on-label ophthalmic bevacizumab-vikg formulation for wet AMD, the release said.
The company also plans clinical registration trials of the drug in diabetic macular edema and branch retinal vein occlusion.
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