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Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones
Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) ISELIN, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced recent corporate highlights and financial results for its fiscal third quarter ended June 30, 2023. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, “We continue to be focused on our pre-launch activities and positioning for Outlook Therapeutics as an innovative leader in the anti-VEGF space. By meeting strict FDA requirements for an ophthalmic approved formulation of bevacizumab, we believe we can enhance the standard of care. If we achieve FDA approval, it will be the catalyst to transform Outlook Therapeutics into a commercial-stage company.” Upcoming Anticipated Milestones PDUFA goal date of August 29, 2023;Evaluation of ONS-5010 in a pre-filled syringe in the NORSE SEVEN clinical trial expected to be complete in 2024; andMAA decision date from the EMA’s CHMP in the EU for ONS-5010 expected in first half of 2024. Commercial Planning Underway to Support Potential Approval of the First Ophthalmic Formulation of Bevacizumab for Use in Retinal Indications According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States alone. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases. Because patients, physicians and payors rely heavily on bevacizumab as an important option for treating wet AMD, ONS-5010 has been developed to address the concerns for not meeting standards required for ophthalmic approval, including potential potency and safety issues that have been reported to be associated with using off-label, repackaged bevacizumab from compounding pharmacies, such as: Study reports published in JAMA indicating 81% of...