Business
Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update
Upcoming Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Upcoming 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)Pre-launch commercial activities continue in preparation for potential approval and launch of ONS-5010 ISELIN, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2023. “We continue to make significant progress in our pre-launch activities as we approach our PDUFA goal date set for August 29, 2023, just three short months away. These initiatives are focused on positioning Outlook Therapeutics as an upcoming leader in the anti-VEGF space by meeting FDA requirements for an ophthalmic approval. The ONS-5010 Biologics License Application (BLA) was submitted and accepted for filing by the FDA as a 351(a) stand-alone BLA. We believe ONS-5010, if approved, has the potential to be the standard of care in the retinal anti-VEGF space and look forward to potentially bringing to market the first FDA-approved ophthalmic formulation of bevacizumab,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. Upcoming Anticipated Milestones Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023;PDUFA goal date of August 29, 2023;Continued evaluation of ONS-5010 in a pre-filled syringe in the NORSE SEVEN clinical trial; andEstimated decision date from the EMA’s CHMP on the Company’s submitted MAA in the EU for ONS-5010 expected in early 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...