Outlook Therapeutics reports topline results and positive proof-of-concept for ONS 5010 / Lytenava from NORSE 1 trial to treat wet AMD.

Outlook Therapeutics, Inc. announced topline results demonstrating anticipated safety and efficacy and positive proof-of-concept of ONS 5010 / LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD) from its NORSE 1 clinical study , the first of two registration clinical trials. ONS 5010 is the first injectable ophthalmic formulation of bevacizumab-vikg seeking FDA approval for the treatment of wet AMD under a new Biologics License Application (BLA). In NORSE 1 , there were no statistical differences between Lucentis (ranibizumab) and ONS 5010 in the study. Overall, 2 of 25 (8%) patients on the ONS 5010 arm achieved > 15 letters best corrected visual acuity (BCVA) at Month 11 compared to 5 of 23 (22%) patients on the ranibizumab arm. In the subgroup analysis of treatment-naïve subjects, 2 of 6 (33%) patients on the ONS 5010 arm achieved > 15 letters at Month 11 compared to 4 of 13 (31%) patients in the ranibizumab arm. Additionally, the subgroup analysis of patients who had a baseline visual acuity of < 67 letters (20/50 or worse) at study entry included 2 of 4 (50%) patients in the ONS-5010 arm and 4 of 9 (44%) patients in the ranibizumab arm achieving > 15 letters at Month 11. These key subgroups represent the enrollment criteria for patients in the fully enrolled, pivotal NORSE 2 clinical trial. The results from NORSE 1 indicate that the observed safety profile of ONS 5010 in this study is consistent with that of previously reported bevacizumab ophthalmology studies. There were no statistical differences in safety between Lucentis (ranibizumab) and ONS 5010 in the study and zero cases of ocular inflammation. The results from NORSE 1 provide support for the established design and protocol for the ongoing pivotal NORSE 2 clinical trial, the second of two registration clinical trials evaluating ONS 5010 for treatment of wet AMD; NORSE 2 excludes patients with vision better than 20/50 at baseline, as well as patients who have received prior treatment for wet AMD. NORSE 2 is powered for statistical significance, and by excluding such patients, Outlook Therapeutics believes that NORSE 2 has enrolled the optimal patients for meeting the endpoint of the study. Outlook Therapeutics recently completed patient enrollment in NORSE 2, its 227-patient Phase III registration clinical trial evaluating ONS 5010 for the treatment of patients with wet AMD. Patients in the trial are being treated for 12 months. The primary endpoint for NORSE 2 is the difference in proportion of patients who gain at least 15 letters in BCVA at 11 months for ONS 5010 dosed on a monthly basis, compared to Lucentis, which is being dosed quarterly per the PIER regimen. Outlook Therapeutics expects to report pivotal safety and efficacy data from NORSE 2 in the third calendar quarter of 2021.. Comment: Outlok shares closed y down 36% to $0.82 following news data from the Phase III NORSE 1 trial of ONS 5010, for the treatment of wet age-related macular degeneration (wet AMD) which showed no statistical improvement when compared with Lucentis (ranibizumab).