Shares in the company climbed more than 30% premarket following the news of the study findings. The major reason is believed to be the performance of bevacizumab.
The performance of bevacizumab drug benefits the company at mass.
Topline results from Outlook Therapeutics’ pivotal Phase III NORSE TWO safety and efficacy trial show the biopharmaceutical company’s ONS-5010/LYTENAVA™ (bevacizumab) significantly improved outcomes in patients with neovascular age-related macular degeneration (wet AMD). Shares in the company climbed more than 30% premarket following the news of the study findings.
The late-stage trial, dubbed NORSE TWO, included 228 patients with wet AMD who were treated with ONS-5010 dosed monthly or LYTENAVA™ for 12 months. Investigational agent ONS-5010 is a humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody and ophthalmic bevacizumab formulation under development for intravitreal injection to treat wet AMD.
While the researchers dosed ONS-5010 monthly, LUCENTIS® was dosed according to the regimens in the LUCENTIS® label; as such, patients in the latter arm received the therapy each month for the first three months with less frequent dosing thereafter.
In the intention-to-treat (ITT) population, a significantly higher proportion of patients in the bevacizumab-vikg arm gained at least 15 letters compared with the ranibizumab arm (41% vs. 23%, respectively; p=0.0052). Similar significant and clinically relevant findings were also reported in the secondary per-protocol dataset (41% vs. 24%; p=0.04).
Additionally, in the primary ITT population, the key secondary endpoint of Best Corrected Visual Acuity (BCVA) score change from baseline to 11 months was also considered statistically significant and clinically relevant (p=0.0043). The mean change in BCVA was 11.2 letters for bevacizumab-vikg compared with 5.8 letters for ranibizumab. Similarly, the mean BCVA change in the per-protocol dataset was 11.1 letters for bevacizumab-vikg and 7.0 letters for ranibizumab (p=0.05).
Safety results in the Phase III trial were reportedly consistent with safety results from the company’s NORSE ONE and NORSE THREE trials. Only one participant experienced ocular inflammation after bevacizumab-vikg in all three clinical trials. The single related ocular serious adverse event in the bevacizumab-vikg in NORSE TWO was resolved. Intravitreal injection-related hemorrhage in the tissues on the eye’s surface was the most common ocular adverse event, but this was also resolved without sequela.
Outlook Therapeutics’ president and chief executive officer, C. Russell Trenary III, said in a statement on the study findings that the company plans to soon bring the bevacizumab ophthalmic formulation to market if ultimately 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,” said Trenary III. “The successful completion of this trial is the final step needed in our clinical evaluation of ONS-5010 to enable us to submit a Biologics License Application (BLA) to the FDA in the first calendar quarter of next year.”
The company’s chief operating officer, Terry Dagnon, added the NORSE TWO clinical trial results have helped Outlook Therapeutics achieve “the requirements agreed upon with the FDA, and when combined with our previously reported clinical trial results, this completes the clinical package necessary for the submission of our BLA.”
“Clearly, in this trial ONS-5010 appears to be a potential option as an ophthalmic bevacizumab,” said clinical trial investigators Firas Rahhal, M.D., who is a senior partner at Retina-Vitreous Associates Medical Group and associate clinical professor of ophthalmology at the UCLA School of Medicine. “As a clinician, I look forward to supporting the submission for FDA approval and including ONS-5010 as an important treatment option for wet AMD patients, if approved.”
