Outlook Therapeutics completes Phase 3 NORSE TWO safety and efficacy trial for ONS-5010, an investigational ophthalmic formulation of bevacizumab for treatment of wet AMD.
On August 3, Outlook Therapeutics announced positive clinical results and statistically significant top-line data from its pivotal Phase 3 NORSE TWO safety and efficacy trial assessing ONS-5010 / LYTENAVA™ (bevacizumab) for treatment of neovascular age-related macular degeneration (wet AMD). The biopharmaceutical company is working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications.
NORSE TWO enrolled 228 participants in the wet AMD at 39 U.S. clinical trial sites. The study yielded high statistical significance across primary and secondary endpoints, and ONS-5010 was demonstrated to be safe and well tolerated.
“We are delighted with the compelling results observed in NORSE TWO, which represent a significant and potentially transformational milepost for patients suffering from wet AMD,” said C. Russell Trenary III, President and CEO of Outlook Therapeutics. “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.”
NORSE TWO is the final step needed in clinical evaluation of ONS-5010. From here, Outlook Therapeutics plans to file a Biologics License Application (BLA) to the U.S. FDA in early 2022, targeting Q1.
“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 to the FDA in the first calendar quarter of next year,” said Trenary. “I would like to thank the trial participants and investigators, our partners, and our employees for their contributions to NORSE TWO.”
If approved, ONS-5010 will likely receive 12 years of marketing exclusivity as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat retinal disease.
Outlook Therapeutics has tentatively been granted an ATC code for ophthalmic bevacizumab by the World Health Organization. Also, SME Entity Status has been granted by the EMA.
For additional information on the ONS-5010 pipeline, visit Outlook Therapeutic’s website.