ONS-5010 for wet AMD shows positive 12-month safety data - Healio
September 28, 2021
1 min read
Full-year results from a pivotal phase 3 trial confirm previously reported data demonstrating ONS-5010 was well tolerated and had no unanticipated safety signals, according to a press release from Outlook Therapeutics.
NORSE TWO enrolled 228 patients with wet age-related macular degeneration at 39 sites across the U.S. to compare ONS-5010/Lytenava (bevacizumab-vikg) vs. Lucentis (ranibizumab, Genentech). The study's primary endpoint was the proportion of patients who gained at least 15 letters in best corrected visual acuity at 11 months. Topline data demonstrated ONS-5010 met its primary and secondary endpoints for efficacy.
At 12 months, safety data from the NORSE TWO trial were consistent with the NORSE ONE and NORSE THREE trials. In all three trials, only one patient had an adverse event of ocular inflammation.
In NORSE TWO, one patient in the ONS-5010 treatment arm had an ocular serious adverse event, but it resolved. There were no unanticipated safety signals, and the most common adverse event was intravitreal injection-related conjunctival hemorrhage.
Outlook Therapeutics plans to submit a biologics license application for ONS-5010 to the FDA in the first quarter of 2022.
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