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Outlook Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for ONS-5010 as a Treatment for Wet AMD
ONS-5010 / LYTENAVA™ (bevacizumab-vikg), if approved, expected to receive 12 years of marketing exclusivity ISELIN, N.J., March 31, 2022 (GLOBE NEWSWIRE) --
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"ONS-5010 / LYTENAVA™ (bevacizumab-vikg), if approved, expected to receive 12 years of marketing exclusivity ISELIN, N.J., March 31, 2022 (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 it has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD). If approved, LYTENAVA™ (bevacizumab-vikg) could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies for the treatment of wet AMD.“This BLA submission for our investigational ONS-5010 not only marks a very significant moment for Outlook Therapeutics, but represents a real step forward for potentially providing an on-label, FDA-approved alternative for the most frequently used anti-VEGF treatment in wet AMD patients in the United States,” said Russ Trenary, President and Chief Executive Officer, Outlook Therapeutics. “If approved for marketing, we hope to see our ophthalmic bevacizumab become a valuable on-label therapy offering clinicians and their patients a safe and effective ophthalmic formulation of a treatment whose value has been proven over many years of clinical practice. We are excited for the potential to offer an ophthalmic bevacizumab formulation that ships straight from our factory partners to distribution centers while avoiding the risks of using unapproved repackaged IV bevacizumab that is approved for intravenous use but not for intravitreal administration.” In anticipation of potential FDA marketing approval in late 2022 or early 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for finished drug product. The Company also is actively building out its distribution and commercial team structures. “The significant efficacy results we are submitting from our NORSE TWO Phase 3 pivotal trial demonstrated the one-, two- and three-line visual acuity responders...