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Outlook Therapeutics Provides Update on Progress Towards First Approved Ophthalmic Formulation of Bevacizumab-vikg for Advanced Macular Degeneration
MONMOUTH JUNCTION, N.J., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a late clinical-stage biopharmaceutical company
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"MONMOUTH JUNCTION, N.J., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a late clinical-stage biopharmaceutical company developing the first FDA-approved ophthalmic formulation of bevacizumab-vikg (LYTENAVA™) for use in retinal indications (known as ONS-5010). Outlook Therapeutics is advancing on multiple fronts, including: progress on its Phase 3 clinical program, manufacturing and regulatory activities, and global strategic partnering negotiations, all leading to the planned commercial launch of ONS-5010 anticipated in 2022. In addition, Outlook Therapeutics recently completed a strategic partnership for commercialization in Greater China and is in discussions with other strategic partners for commercial launches in the United States, Asia and Europe.\n Clinical Progress Drives ONS-5010 Towards U.S. and EU Filings in 2021Outlook Therapeutics has already demonstrated both safety and efficacy through a recently reported clinical experience trial and, separately, has also completed enrollment of 227 patients in its U.S.-based Phase 3 pivotal trial. The clinical experience trial gives Outlook Therapeutics a high level of confidence in the outcome of the ongoing fully-enrolled pivotal trial. Pivotal data are expected mid-2021 followed by submission of a U.S. Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). If the BLA is approved, it will result in 12 years of marketing exclusivity. Outlook Therapeutics is on track for both U.S. BLA filing and EU Marketing Authorization Application (MAA) filings in 2021. ONS-5010 Addresses Significant Unmet Medical NeedAlthough unapproved repackaged IV Avastin® from compounding pharmacists is widely used by retinal specialists, extensive marketing research has indicated that there is a significant unmet medical need for an approved ophthalmic formulation of bevacizumab that removes both the product liability and safety concerns of a repackaged product. Once approved, Outlook Therapeutics’ ONS-5010 will reduce the need for use of unapproved repackaged IV Avastin® from compounding pharmacists. Upon approval, ONS-5010 will be the first ophthalmic formulation of bevacizumab-vikg approved as an anti-VEGF therapy addressing vision loss from wet age-related macular degeneration (wet AMD). Outlook Therapeutics also intends to seek approval ...