Outlook Therapeutics Submits Type A Meeting Request Following FDA CRL On ONS-5010 For Wet AMD

Outlook Therapeutics, Inc. announced that it has submitted a Type A Meeting request to the U.S. Food and Drug Administration (FDA) regarding the complete response letter (CRL) received on August 27, 2025, for its biologics license application (BLA) resubmission of ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab being developed for the treatment of wet age-related macular degeneration (wet AMD).

In the CRL, the FDA acknowledged that the NORSE TWO pivotal trial met both its safety and efficacy endpoints but advised that additional confirmatory evidence of efficacy is required to support approval of ONS-5010. The requested Type A meeting will aim to clarify the scope and nature of the confirmatory evidence the FDA expects.

“We believe this Type A meeting will provide us with additional clarity on the FDA’s requirements to remedy the deficiency identified in the CRL. The Outlook Therapeutics team remains dedicated to our mission to provide patients in the U.S. with a safe and effective alternative to compounded bevacizumab, which has been used off-label as a first-line treatment for wet-AMD for years despite concerns around potency, sterility, consistency and regulatory oversight associated with the use of compounded products,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. 

ONS-5010, marketed in Europe and the UK under the trade name LYTENAVA™ (bevacizumab gamma), has already received centralized Marketing Authorization by the European Commission and approval by the UK’s MHRA for the treatment of wet AMD. In the U.S., ONS-5010 remains investigational. In certain EU member states, pricing and reimbursement approvals must still be secured before commercial sales can begin.