On November 13 2025, the U.S. Food and Drug Administration accepted Outlook Therapeutics’ resubmission of the Biologics License Application for ONS‑5010, the ophthalmic formulation of bevacizumab that the company intends to market under the brand name LYTENAVA. The acceptance is a Class 1 response, meaning the agency expects a full review within 60 days and has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31 2025.
The agency’s decision follows a complete response letter issued on August 27 2025 that highlighted chemistry, manufacturing, and controls (CMC) deficiencies and requested additional data from the NORSE EIGHT clinical trial. Outlook addressed those concerns in a February 2025 resubmission, incorporating new CMC documentation and the trial’s week‑12 non‑inferiority results. The FDA’s Class 1 designation signals that the agency believes the resubmission fully resolves the prior deficiencies and de‑risks the approval pathway.
The approval of ONS‑5010 would make it the first FDA‑approved ophthalmic bevacizumab, a product that has been widely used off‑label for wet age‑related macular degeneration (wet‑AMD). The U.S. wet‑AMD market is estimated at roughly $10 billion annually, and a branded, on‑label product could capture a significant share by offering a standardized, sterile formulation that eliminates the variability and safety concerns associated with compounded bevacizumab. Competition will come from existing anti‑VEGF agents such as ranibizumab and aflibercept, but LYTENAVA’s lower cost and established manufacturing could provide a competitive edge.
Outlook’s financial position underscores the importance of this regulatory milestone. The company has reported negative operating margins and a high cash burn rate, with limited revenue streams outside of its development pipeline. Successful FDA approval would unlock a 12‑year exclusivity period and provide the first revenue source for the company, potentially transforming its balance sheet and enabling future clinical development and commercialization investments.
CEO Bob Jahr said, “We are pleased that the FDA has accepted our resubmission of the BLA for ONS‑5010, marking another important milestone in our effort to bring the first and only FDA‑approved ophthalmic formulation of bevacizumab to patients in the United States suffering from wet AMD. Our team has worked diligently to address the feedback from the agency, strengthen the resubmission, and resolve the outstanding issues highlighted in the August 2025 complete response letter.”
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