(RTTNews) - Outlook Therapeutics, Inc. (OTLK) announced that it has submitted a Type A meeting request to the U.S. FDA after receiving a Complete Response Letter dated December 30, 2025, regarding its Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration.
The CRL identified a single deficiency, citing a lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics stated that it intends to leverage data from its NORSE TWO and NORSE EIGHT clinical trials to address the FDA's concerns.
LYTENAVA has already been approved in Europe and the UK for wet AMD, where it became commercially available in Germany and the UK in June 2025.
During fiscal year 2025, Outlook Therapeutics reported $1.4 million in revenue, primarily from initial sales in these markets, with expanding adoption among clinicians and inclusion in the UK tender framework. In the U.S., however, ONS-5010/LYTENAVA remains investigational.
Wet AMD is a leading cause of vision loss in older adults, characterized by abnormal blood vessel growth and leakage under the retina. Anti-VEGF injection therapy, such as bevacizumab, is the current standard of care.
LYTENAVA is designed to provide a cost-effective, on-label ophthalmic formulation of bevacizumab specifically for intravitreal use.
OTLK has traded between $0.38 and $3.39 over the past year. The stock is currently trading at $0.42, up 1.35%.
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