OTLK News & Events

Outlook Therapeutics provided an update following its recent Type A meeting with the FDA to discuss the December 30, 2025 complete response letter for the biologics license application, or BLA, for ONS-5010/Lytenava. The Type A meeting was conducted to clarify the outstanding issue identified in the CRL regarding substantial evidence of effectiveness and to discuss potential paths forward for regulatory approval. The company expects to continue engaging in discussions with the FDA to further clarify the Agency's views on confirmatory evidence and the appropriate path forward. Outlook Therapeutics is evaluating the available regulatory options to advance ONS-5010 toward potential U.S. approval. "We appreciate the FDA's engagement during the Type A meeting and remain committed to working constructively with the Agency," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "Our goal is to reach alignment on the confirmatory evidence supporting our application and to identify the most efficient pathway toward potential approval."

Outlook Therapeutics announced they have entered into an exclusive commercial distribution agreement for the sale and distribution of Lytenava in the Switzerland market. Under the terms of the agreement, Mediconsult will hold exclusive rights to market, import, distribute and commercialize Lytenava in Switzerland under Outlook Therapeutics' trademark. Mediconsult will also be responsible for regulatory activities in Switzerland, including seeking and maintaining Marketing Authorization, as well as leading other commercialization efforts in the country. Outlook Therapeutics will retain responsibility for manufacturing, product supply and the maintenance of all related intellectual property.

"Lytenava is demonstrating increasing adoption in Europe following our initial launches, with growing demand and quarter-over-quarter unit sales growth," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "Building on this momentum, we are actively working towards launching into additional EU markets in the near term, following our January launch into Austria, as part of a broader regional expansion strategy."

Outlook Therapeutics submitted a Type A meeting request to the U.S. Food and Drug Administration following receipt of a Complete Response Letter dated December 30, regarding the Company's Biologics License Application for ONS-5010/LYTENAVA for the treatment of wet age-related macular degeneration. The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Based on prior discussions with the FDA in September 2025, during which Outlook Therapeutics understood that it had aligned with FDA on the requirements for resubmission of the BLA, the issuance of an additional CRL was unexpected. Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL. The BLA for ONS-5010 is supported by clinically meaningful data, including results from NORSE TWO, a single adequate and well-controlled Phase 3 trial that demonstrated statistically significant and clinically relevant improvements in visual acuity at 12 months. NORSE TWO met its primary endpoint - patients gaining three lines of visual acuity - and a key secondary endpoint of mean change from baseline in visual acuity. Additional secondary endpoints, including gains of one line, two lines, and preservation of vision, further reinforce the robustness and consistency of the treatment effect. At FDA's request, Outlook Therapeutics also conducted NORSE EIGHT, a second adequate and well-controlled Phase 3 study. While NORSE EIGHT did not meet its primary endpoint at 8 weeks, the study demonstrated a positive trajectory consistent with NORSE TWO through 12 weeks of treatment and provided important functional and mechanistic/pharmacodynamic evidence of efficacy. Specifically, NORSE EIGHT showed consistent gains in best-corrected visual acuity across all measured timepoints, low variability, and results aligned with the established anti-VEGF mechanism of action. In addition to NORSE TWO and NORSE EIGHT, Outlook Therapeutics submitted a comprehensive package of confirmatory evidence, including mechanistic and pharmacodynamic data demonstrating VEGF inhibition and natural history data showing that the observed improvements with ONS-5010 represent a clear departure from the expected progression of untreated wet AMD. Outlook Therapeutics believes the resubmitted BLA fully satisfied the substantial evidence standard for demonstrating effectiveness, and intends to continue to work with the FDA on a path forward for resolving the FDA's request for additional confirmatory evidence. ONS-5010 also demonstrated a favorable safety profile, with ocular adverse reactions consistent with both the control arm and with intravitreal injections generally and the FDA has never expressed any safety concerns with ONS-5010. The availability of an FDA-approved bevacizumab product for wet AMD would provide patients and physicians with a consistent, high-quality, commercially manufactured option supported by FDA-approved labeling, standardized manufacturing, and robust pharmacovigilance.