ONS 5010 refiled with FDA for wet age-related macular degeneration
Outlook Therapeutic announced it has re-submitted its Biologics License Application (BLA) to the FDA for ONS 5010, an investigational ophthalmic therapy which, if approved, will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD)
The BLA re-submission is based on the totality of data from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE – as well as a Phase I pharmacokinetic clinical trial and the necessary pre-clinical testing.
NORSE ONE was a clinical experience trial involving 61 wet AMD participants at nine trial sites in Australia. It compared ONS 5010 to ranibizumab (LUCENTIS) as a treatment for wet AMD. NORSE ONE showed the first markers of efficacy and safety in humans for ONS 5010 ophthalmic bevacizumab. In the trial, ONS 5010 efficacy and safety data were consistent with historical published studies of bevacizumab in ophthalmology. NORSE ONE also supported the trial design and inclusion/exclusion criteria established for NORSE TWO, the pivotal Phase III registration clinical trial.
The NORSE TWO Phase III pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. It was designed as a superiority study comparing the safety and efficacy of ONS 5010 ophthalmic bevacizumab dosed monthly against ranibizumab (Lucentis) dosed according to the PIER dosing regimen described in the Lucentis label. The trial data met both their primary and secondary endpoints with high statistical significance and clinical relevance. For its primary endpoint, 41.7% (p = 0.0052) of patients gained at least 15 letters of vision, and for its secondary endpoints 56.5% (p = 0.0016) of subjects gained at least 10 letters of vision and 68.5% (p = 0.0116) gained at least 5 letters. The key secondary endpoint was met: mean change in BCVA from baseline to Month 11, which was 11.2 letters gained compared to 5.8 letters gained in the ranibizumab arm (p = 0.0043). The NORSE TWO data also showed that the drug was well-tolerated, consistent with previously reported data for ONS 5010 and prior research.
NORSE THREE was an open-label safety study of ONS 5010 in 197 patients conducted in the United States to provide the necessary number of retina patients dosed with ONS 5010 to complete the requirements for the BLA submission. Safety results across the first three NORSE trials demonstrated a strong benefit-to-risk safety profile. Across all three ONS 5010 registration trials, there was only one ocular inflammation adverse event.
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