Outlook Therapeutics, Inc. (OTLK), a clinical-stage biotechnology company, announced on Tuesday that the U.S. Food and Drug Administration FDA has accepted its Formal Dispute Resolution Request or FDRR and has granted a meeting with the deciding official to be conducted in April 2026 for its lead asset ONS-5010/LYTENAVA.
Notably, the formal dispute resolution request (FDRR) was submitted to the FDA as a follow-up to its recent Type A meeting on March 2, 2026, following receipt of the earlier Complete Response Letter.
ONS-5010/LYTENAVA is an investigational ophthalmic formulation of Bevacizumab for the treatment of age-related macular degeneration (AMD).
On December 30 2025, Outlook received a Complete Response Letter (CRL) from the FDA for the resubmitted ONS-5010/LYTENAVA (Bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (AMD), and the type A meeting was held regarding that.
In the CRL, the FDA indicated that it cannot approve the application in its current form for the treatment of wet age-related macular degeneration (wet AMD) and recommended that confirmatory efficacy data be submitted to support the application.
Outlook's submission includes existing clinical, functional, and pharmacodynamic data, as well as safety findings, that support the efficacy and safety of ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration.
In the NORSE TWO randomised, double-masked, active-controlled Phase 3 trial, ONS-5010/LYTENAVA demonstrated clinically meaningful improvements in visual acuity and met its key primary and secondary endpoints. In addition, the firm believes evidence from NORSE EIGHT and other data submitted in the BLA further support the efficacy and safety profile of ONS-5010, consistent with its anti-VEGF mechanism of action.
LYTENAVA has already been approved in Europe and the UK for wet AMD, and it became commercially available in Germany and the UK in June 2025. In the United States, it still remains investigational.
According to the firm, if approved in the US, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of Bevacizumab supported by standardised manufacturing, FDA-approved labelling, and robust pharmacovigilance.
OTLK has traded between $0.16 and $3.39 in the last year. The stock closed Tuesday's trade at $0.21, up 6.18%.
In the overnight market, OTLK is up 20.75%, at $0.25.
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