Bevacizumab-vikg meets endpoints in phase 3 wet AMD trial
ONS-5010 demonstrated statistically significant results in the treatment of patients with wet age-related macular degeneration, according to a press release from Outlook Therapeutics.
The phase 3 NORSE TWO safety and efficacy trial, evaluating ONS-5010/Lytenava (bevacizumab-vikg) compared with Lucentis (ranibizumab, Genentech), enrolled 228 patients with wet AMD. The primary endpoint was the proportion of patients who gained at least 15 letters in best corrected visual acuity at 11 months, the release said, while the secondary endpoint was the mean change in BCVA through 11 months.
For the primary endpoint in the intent-to-treat primary data set, 41% of patients treated with bevacizumab-vikg gained at least 15 letters at 11 months compared with 23% of patients treated with ranibizumab (P = .0052). Regarding the secondary endpoint, patients treated with ranibizumab gained an average of 5.8 letters through 11 months, while patients treated with bevacizumab-vikg gained an average of 11.2 letters (P = .0043).
“We plan on bringing the first ophthalmic formulation of bevacizumab to market, if approved. Currently there are a vast number of off-label injections of bevacizumab to treat retinal disease in the United States, and we want to offer an alternative for patients and retinal surgeons that is approved and formulated and packaged specifically for wet AMD,” C. Russell Trenary III, president and CEO of Outlook Therapeutics, said in the release.
There was one serious adverse event in the bevacizumab-vikg study arm that resolved with no complications. The most common ocular adverse event was conjunctival hemorrhage, which resolved with no further complications.
Outlook Therapeutics plans to submit a biologics license application to the FDA in the first quarter of 2022, the release said.