NORSE TWO Phase III trial of ONS 5010 meets primary and secondary endpoints in wet age-related macular degeneration.- Outlook Therapeutics
The NORSE TWO Phase III pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. NORSE TWO was a superiority trial comparing the safety and efficacy of ONS-5010 ophthalmic bevacizumab dosed monthly against Lucentis (ranibizumab) dosed according to the PIER regimen in the Lucentis labeling.
Participants in the trial were treated for 12 months, with the primary endpoint at Month 11 being the difference in proportion of patients who gained at least 15 letters (3 lines) in best corrected visual acuity (BCVA). The key secondary endpoint was the mean change in BCVA from baseline to Month 11. NORSE TWO data showed a strong safety profile, results consistent with previously reported safety data for ONS-5010, and similar to safety levels reported in prior research for bevacizumab used off-label in ophthalmology. The NORSE TWO pivotal data met both primary and secondary endpoints with statistically significant and clinically relevant results: 41.7% (p = 0.0052) ONS-5010 subjects gained at least 15 letters of vision. 56.5% (p = 0.0016) ONS-5010 subjects gained at least 10 letters of vision. 68.5% (p = 0.0116) ONS-5010 subjects gained at least 5 letters of vision. ONS-5010 subjects gained 11.2 letters (p = 0.0043) in BCVA.
Results from NORSE TWO also demonstrated that ONS 5010 has a strong safety profile. In findings that are consistent with historical bevacizumab data reported in prior research, in all three ONS-5010 registration trials there was only one ocular inflammatory adverse event, which was treated topically and resolved without sequelae. The safety findings continue to support minimal ocular inflammation and safety signals consistent with what was previously reported in the 2011 CATT trial (National Eye Institute) and other large bevacizumab-controlled ophthalmic studies. Data were presented at the Retinal Subspecialty Day, AAO 2021 Annual Conference.
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