2024-03-31 09:25:35 ET
Summary
- The positive CHMP opinion could mean possible European Approval; European Commission expected to decide upon approval for this in the next few months.
- Phase 3 NORSE EIGHT study underway using ONS-5010 for the treatment of patients with Wet-AMD; Data expected to be released in Q4 of 2024.
- Pending the primary endpoint of BCVA in NORSE EIGHT being met with statistical significance, BLA filing of ONS-5010 for Wet-AMD expected in 2024.
- The anti-VEGF market size is projected to reach $13.54 billion by 2030.
Outlook Therapeutics ( OTLK ) has made significant progress in advancing the use of its drug ONS-5010, which is being developed for the treatment of patients with wet age-related macular degeneration [Wet-AMD]. The use of this anti-VEGF drug is being explored in several studies, but the company is on the right track with de-risked events as it relates to the regulatory side of things, despite the fact that it had a major roadblock on the past with the FDA. Not only was it able to get to the FDA to agree to a Special Protocol Assessment [SPA] with the FDA to possibly file a Biologics Licensing Application [BLA] to the FDA for Wet-AMD, but it also received a positive opinion from the CHMP recommending approval of this drug for the treatment of this patient population....
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Outlook Therapeutics: De-Risked Regulatory Tracks Are Lining Up For Possible ONS-5010 Approval