FDA Accepts Outlook Therapeutics' Resubmitted BLA For ONS-5010 In Wet AMD, Decision Due This Month

(RTTNews) - Shares of Outlook Therapeutics (OTLK) rose nearly 15% to $1.47 in after-hours trading, following a regulatory update related to its resubmitted Biologics License Application for ONS-5010.

ONS-5010 is an investigational ophthalmic formulation of bevacizumab proposed for the treatment of wet age-related macular degeneration.

The FDA has accepted the resubmitted Biologics License Application for ONS-5010 and has assigned a decision date of December 31, 2025.

ONS-5010, if approved, will be branded as LYTENAVA, and will be the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD.

ONS-5010 is recombinant humanized monoclonal antibody that binds with high affinity to all isoforms of vascular endothelial growth factor (VEGF). By blocking VEGF activity, it prevents abnormal blood vessel growth, vascular leakage, and neovascularization in the retina- key drivers of vision loss in wet AMD.

Wet AMD is a leading cause of vision loss in older adults, driven by abnormal blood vessel growth and leakage in the retina. Current treatment in the U.S. often relies on off label compounded bevacizumab, which lacks FDA approval.

The resubmission follows Outlook's efforts to address issues raised in the FDA's August 2025 Complete Response Letter. ONS-5010 has been evaluated in Phase 3 studies, where intravitreal administration demonstrated efficacy in reducing endothelial cell proliferation, vascular leakage, and abnormal vessel growth in the retina.

ONS-5010 has already received centralized Marketing Authorization in the European Union and approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for wet AMD. In the U.S., this represents the first indication Outlook is seeking approval for with ONS-5010.

If approved, Outlook anticipates a potential U.S. launch of LYTENAVA in early 2026 and will continue pursuing reimbursement approvals in Europe and the UK.

ARQT has traded in the range of $0.79- $5.53 over the past year. The stock closed yesterday's trading at $1.47.86, up 14.84%.