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Press Release

March 31, 2021
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Positive topline safety results reported for ONS-5010 in retinal disease treatment

Source:

Press Release

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Topline results from an open-label safety study investigating ONS-5010/Lytenava in the treatment of retinal diseases showed no unexpected safety results, according to a press release from Outlook Therapeutics.

The NORSE THREE study included 197 patients with varying retinal diseases in which anti-VEGF injections may be used as a treatment, the release said. Enrolled patients received three monthly intravitreal doses of ONS-5010 (bevacizumab-vikg).

Endpoints for the trial included frequency and incidence of treatment-emergent adverse events and an evaluation of changes in safety parameters, the release said.

Twenty patients experienced an adverse event related to the injection procedure, not the therapy itself, and there were no serious adverse events associated with treatment. There were no cases of ocular inflammation, the release said.

“The additional validation of the ONS-5010 safety profile seen in the results of this study, which match up favorably with historical data from prior studies of bevacizumab in ophthalmology, is very encouraging,” Mark Humayun, MD, PhD, medical advisor to Outlook Therapeutics, said in the release.

Outlook Therapeutics plans to submit a new biologics license application for ONS-5010 in the fourth quarter, after the release of efficacy and safety data from the phase 3 NORSE TWO study, the release said.