Ophthalmic bevacizumab shows promising vision gain in wet AMD in phase 3 study
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NEW ORLEANS — An ophthalmic formulation of bevacizumab demonstrated good safety and efficacy results in a pivotal phase 3 study in patients with wet age-related macular degeneration.
Firas M. Rahhal, MD, said at Retina Subspecialty Day at the American Academy of Ophthalmology meeting that ONS-5010 (bevacizumab-vikg, Outlook Therapeutics) selectively binds with high affinity to all isoforms of factor VEGF-A. Investigators compared the investigational formulation with ranibizumab in the 12-month NORSE TWO superiority trial.
Patients who were treatment-naive and had best corrected visual acuity between 20/50 and 20/320 were divided into two groups, with 113 patients receiving monthly ONS-5010 injections for 12 months and 115 patients receiving ranibizumab injections for the first 3 months and then every 3 months after that.
The primary outcome of the study was the proportion of patients who gained at least 15 letters, or three lines of vision, in BCVA. The mean change in BCVA from baseline to month 11 and the frequency and incidence of adverse events were also evaluated.
In the ONS-5010 group, 41.7% of patients gained 15 or more letters of vision compared with 23.1% in the control group (P = .0052). Rahhal said the drug showed both rapid onset and sustained response over time.
Additionally, Rahhal said safety results in NORSE TWO were consistent with prior studies, and only one case of ocular inflammation was reported.
“The company will be planning to file for FDA approval in the first quarter of 2022 for this product,” Rahhal said.
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Rahhal FM, et al. Safety and efficacy results of ONS-5010, an ophthalmic bevacizumab: Phase 3 pivotal study of monthly intravitreal ONS-5010 in subjects with wet AMD (NORSE TWO). Presented at: American Academy of Ophthalmology meeting; Nov. 12-15, 2021; New Orleans.
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