Outlook Therapeutics announced the completion of patient enrollment in its NORSE 2 clinical trial for ONS-5010/Lytenava (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for use in retinal indications.
“We are extremely grateful to the patients and medical staff who continue to take part in this study, even amidst the effects of the COVID-19 pandemic. The hard work and dedication shown by these individuals have made it possible for us to achieve this important milestone, which now starts the clock to the completion of the study and to our reporting of pivotal data, expected in the third calendar quarter of 2021,” Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics, said in a company news release.
The NORSE 2 clinical trial commenced patient enrollment in July 2019. Due to the number of patients in screening at the time of achieving the trial’s stated goal of enrolling 220 patients in the study, Outlook Therapeutics has enrolled 227 patients at 39 clinical trial sites in the United States. 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 the best corrected visual acuity (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 in the third calendar quarter of 2021.
“Within the retina community, the use of anti-VEGF therapy continues to be the standard of care for many ophthalmic diseases. Given the high cost of the present FDA-approved anti-VEGF therapies, many physicians have turned to off-label repackaged bevacizumab supplied by compounding pharmacists,” Mark Humayun, MD, Medical Advisor for Outlook Therapeutics, said in a company news release. “There is significant unmet patient need for an FDA-approved bevacizumab for use in treating retinal diseases. I believe that Lytenava, if approved, will offer clinicians an important new safe and effective, on-label anti-VEGF therapy option across the spectrum of retinal care.”
Outlook Therapeutics intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD and also has plans to submit for regulatory approvals in Europe and Japan, as well as other countries.
If approved, ONS-5010 will be the first and only on-label ophthalmic formulation of bevacizumab for treating retinal diseases and has the potential to address a $9.1 billion anti-VEGF market.