FDA knocks back Outlook Therapeutics' ophthalmic formulation of bevacizumab

2023-08-30

临床结果

The FDA issued a complete response letter to Outlook Therapeutics' application seeking approval of ONS-5010, an ophthalmic formulation of the anti-VEGF monoclonal antibody bevacizumab, the company said Wednesday. The agency indicated that it would need further confirmatory clinical evidence before approving ONS-5010, and also raised manufacturing issues, sending Outlook's shares down as much as 78%.

While the FDA acknowledged the pivotal NORSE TWO trial met its safety and efficacy endpoints, it concluded that it could not approve ONS-5010 due to the outstanding issues. "We will request a formal meeting as soon as possible with the FDA to further understand the…deficiencies and how best to resolve them," remarked CEO Russell Trenary, adding that the company will then "be able to discuss next steps and the expected timing for resolution."

For the primary endpoint of the NORSE TWO study, results showed that a significantly higher 41.7% of patients treated with ONS-5010 achieved best-corrected visual acuity (BCVA) of ≥15 letters from baseline to 11 months, versus 23.1% for Novartis/Roche's Lucentis (ranibizumab). Meanwhile, patients receiving ONS-5010 also demonstrated a statistically significant mean change in BCVA of 11.2 letters compared to 5.8 letters in the control arm – a key secondary endpoint of the study.

Second filing setback

Outlook initially sought FDA approval of ONS-5010 last year, but withdrew its filing after the regulator asked for additional undisclosed information. The agency accepted the company's resubmitted application in October last year. A filing for the drug, which if approved would be marketed as Lytenava, is also under review in the EU, with the Committee for Medicinal Products for Human Use expected to issue a decision in the first half of 2024.

ONS-5010 is under development as an intravitreal injection to treat wet age-related macular degeneration, a condition that is currently treated with repackaged intravenous bevacizumab provided by compounding pharmacies. Outlook recently indicated that it had cash and cash equivalents of $33.7 million, which would be sufficient to fund its operations through the third quarter of 2023, and potentially the remainder of the year.

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