Outlook Therapeutics Secures FDA Agreement and Funding for ONS-5010 Clinical Trial

In a significant stride towards advancing its clinical development program for ONS-5010, Outlook Therapeutics has received written agreement from the FDA under a special protocol assessment (SPA) for the NORSE EIGHT clinical trial protocol.

This trial aims to evaluate the efficacy of ONS-5010 in subjects with wet age-related macular degeneration (AMD).

Simultaneously, the company announced it has entered into securities purchase agreements with institutional and accredited investors, securing up to $172 million in gross proceeds. This substantial funding infusion is earmarked to fuel the progression of ONS-5010 through its development pathway, from potential FDA approval to launch.

Russell Trenary, President, and Chief Executive Officer of Outlook Therapeutics, expressed confidence in the SPA, stating, “The SPA increases our confidence that ONS-5010, if approved, will more effectively meet the needs of retina surgeons, patients and payers in the $9.5 billion ophthalmic anti-VEGF market in the United States, and the financing represents a significant commitment by our new and existing stockholders to advance this important development program. We believe that the funds we expect to receive in this financing will position Outlook Therapeutics to support the ONS-5010 development pathway through potential FDA approval and launch.”

The FDA has reviewed and endorsed the NORSE EIGHT trial protocol as part of the SPA. The successful outcome of this trial would fulfill the FDA’s requirement for a second adequate and well-controlled clinical trial, addressing the clinical deficiency identified in the complete response letter (CRL).

NORSE EIGHT, a randomized, controlled, parallel-group study, will involve approximately 400 newly diagnosed, wet AMD subjects. Participants will be randomized to receive either 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections, with primary endpoints centered around the mean change in BCVA from baseline to week 8. Outlook Therapeutics anticipates topline results and the resubmission of the ONS-5010 Biologics License Application (BLA) by the end of calendar year 2024.

Furthermore, Outlook Therapeutics has outlined plans to address comments from the CRL, with expectations to resolve these issues before the completion of NORSE EIGHT.

In parallel, the company has also entered into definitive securities purchase agreements, including a private placement, aiming to generate up to $60 million in gross proceeds at closing. An additional $99 million in gross proceeds may be realized upon the full cash exercise of warrants issued in the private placement.

Outlook Therapeutics intends to utilize the net proceeds from these financial initiatives to fund its ONS-5010 clinical development programs, including the NORSE EIGHT trial, and for general corporate purposes.