Outlook Therapeutics announced positive 12-week results from its NORSE EIGHT trial for ONS-5010, an ophthalmic bevacizumab formulation for wet age-related macular degeneration (wet AMD). The treatment demonstrated non-inferiority to ranibizumab (Lucentis) at 12 weeks, paving the way for a Biologics License Application (BLA) resubmission in Q1 2025. The company also secured funding of up to $20.4 million through a warrant inducement transaction.
These 12-week results are crucial as they follow an earlier setback at the 8-week mark, where ONS-5010 did not meet the pre-specified non-inferiority endpoint. The continued improvement in visual acuity up to 12 weeks strengthens the argument for ONS-5010’s efficacy and provides more robust data for the upcoming BLA resubmission. A potential FDA approval for ONS-5010 offers a significant opportunity to address the current reliance on off-label, repackaged bevacizumab for wet AMD treatment, providing a regulated and potentially more cost-effective alternative. This could disrupt the existing market by offering a readily available, approved formulation, potentially impacting both patient access and the market share of current treatments.
In NORSE EIGHT, ONS-5010 achieved a mean improvement of 5.5 letters in best corrected visual acuity (BCVA) at 12 weeks compared to 6.5 letters with ranibizumab. The change in central retinal thickness, a key anatomical indicator, was also comparable between the two treatment groups. Furthermore, ONS-5010 exhibited a positive safety profile, with ocular adverse event rates similar to ranibizumab and no reported cases of retinal vasculitis. The $20.4 million raised from the warrant transaction will support the BLA resubmission, the European launch of LYTENAVA™ (the approved name for ONS-5010 in the EU and UK), ongoing clinical programs, and general corporate operations. The European launch, anticipated in the first half of 2025, positions Outlook Therapeutics to establish a market presence while awaiting US regulatory decisions.
The positive 12-week data and planned BLA resubmission represent a pivotal moment for Outlook Therapeutics. A successful FDA approval would validate ONS-5010 as a viable treatment option for wet AMD, offering a standardized and approved alternative to current off-label bevacizumab use. This would not only benefit patients but also potentially reshape the treatment landscape for this prevalent retinal disease. The combined momentum of the upcoming BLA resubmission and the European launch sets the stage for significant growth and market penetration, pending regulatory outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
