Outlook Therapeutics Inc. (NASDAQ: OTLK) has presented vital efficacy and safety data from the third phase NORSE Two ONS-5010 study. ONS-5010 is an experimental ophthalmic bevacizumab formulation for wet age-related macular denegation and other retinal indications treatment.
The outlook presents ONS-5010 study data
During the Retinal Subspecialty Day, AAO 2021 Annual Conference, the company presented the data. UCLA School of Medicine Clinical Professor of Ophthalmology Firas Rahhal presented the data during Section X: Late-Breaking Developments under a poster, “Safety and Efficacy Results of ONS-5010, as Ophthalmic Bevacizumab, Phase 3 Pivotal Study of Monthly Intravitreal OS-5010 in Subjects with Wet AMD (NORSE TWO).”
Rahhal said, “If approved by the FDA, ONS-5010 will become the first and only on-label ophthalmic bevacizumab, which is very significant for thousands of patients needing anti-VEGF treatments to control their wet AMD. It will be great for patients and their doctors to have more FDA-approved anti-VEGF options that are prepared specifically for intraocular use.”
One ocular adverse event reported
NORSE TWO findings also showed that ONS-5010 ophthalmic bevacizumab has a good safety profile. In all three ONS-5010 registration studies, there was just one ocular inflammatory adverse event, treated topically and resolved without sequelae. The findings were similar to historical bevacizumab data published in past research. The safety data indicate limited ocular inflammation and safety signs, as previously reported in the CATT study in 2011 and other bevacizumab-controlled ophthalmic investigations.
Outlook CEO C. Russell Trenary III said, “With the positive results from NORSE TWO, we are confident that, if approved, ONS-5010 has the potential to become a valuable new tool in the armamentarium of therapies for wet AMD. If approved as the first on-label ophthalmic formulation of bevacizumab, ONS-5010 will enable patients to benefit from wider access and provide an attractive alternative for anti-VEGF treatment of wet AMD. We are moving ahead with our plans to submit our BLA for wet AMD with the FDA in the first quarter of calendar 2022 and working with other global regulatory authorities to bring this important therapy to market.”
