Outlook Therapeutics announced the initiation and enrollment of the first patients in its planned supplemental open-label safety study evaluating ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD) (NORSE THREE).
The open-label safety study is being conducted to ensure that an adequate number of safety exposures to ONS-5010/Lytenava (bevacizumab-vikg) are available to support Outlook Therapeutics’ initial biologics license application (BLA) filing for wet AMD with the FDA. In total, approximately 180 patients with a wide range of different retinal diseases for which an anti-VEGF drug can be used as a therapeutic option, including wet AMD, diabetic macular edema (DME), and branch retinal vein occlusion (BRVO), are expected to be enrolled. Patients in the safety study will receive three doses of ONS-5010 over a 3-month period.
“The initiation of this open-label safety study, the third clinical trial in our wet AMD program, is an important step in our overall development plan for ONS-5010. This study is intended to ensure that enough patients have been treated with ONS-5010 in our streamlined clinical program to support submission for a new BLA,” Lawrence Kenyon, President, CEO and CFO of Outlook Therapeutics, said in a company news release. “With both this supplemental safety study and our fully enrolled pivotal phase 3 trial moving towards completion in the first half of 2021, we remain on track to report the full complement of data needed for our new BLA filing for wet AMD in the third quarter of 2021.”
The data from this supplemental safety study, the results from a previously completed clinical experience trial, which demonstrated anticipated safety and efficacy as well as positive proof-of-concept, and the data from the ongoing, fully enrolled pivotal phase 3 trial will form the complete data set required for a potential new BLA filing for the treatment of wet AMD in the second half of 2021.
While unapproved repackaged IV bevacizumab from compounding pharmacies is already widely used in treating retinal diseases, ONS-5010, if approved, will be the first on-label injectable ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD and other retinal diseases. It will offer a new approved anti-VEGF treatment option across the spectrum of retinal care, currently estimated to be over $13 billion globally for anti-VEGF therapies.
In addition to working towards a new BLA filing under the 351(a) PHSA regulatory pathway, Outlook Therapeutics is also engaged with regulatory authorities in Europe and other major markets for anticipated approvals in those markets. In addition to seeking regulatory approval for treating wet AMD, Outlook Therapeutics intends to initiate registration clinical trials for ONS-5010 for DME and BRVO.
Commercial launch planning for ONS-5010 is ongoing, including distribution, physician and patient outreach, key opinion leader support and payor community engagement. With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010 to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retinal indications. Outlook Therapeutics is also engaged with several life sciences companies that could result in a strategic partnership and definitive agreement for ONS-5010 as soon as the end of 2020.