Outlook Therapeutics Receives FDA Agreement for Special Protocol Assessments

Outlook Therapeutics (NASDAQ:OTLK) has announced it received an agreement from the US Food and Drug Administration (FDA) for three special protocol assessments for three more registration clinical trials in its ongoing Phase 3 program for ONS-5010.

As quoted in the press release:

The agreements reached with the FDA on these SPAs cover the protocols for NORSE 4, a registration clinical trial to treat BRVO, and NORSE 5 and NORSE 6, two registration clinical trials to treat DME. Outlook Therapeutics intends to initiate NORSE 4, 5 and 6 in 2020.

“We are very pleased to reach these agreements with the FDA so that we can continue to build clinical data for additional retinal indications beyond wet AMD for ONS-5010,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. “Anti-VEGF therapy has been the standard of care for years within the retinal community for wet AMD, DME and BRVO, and we hope that ONS-5010 will become the first FDA-approved bevacizumab indicated for these diseases. An on-label bevacizumab would enable clinicians to treat their retinal patients with a well-established therapy, and FDA approval would ensure sterility, potency and accurate, safe syringes for intravitreal injections.”

“The Outlook Therapeutics team truly cares about improving the clinical landscape for retinal patients, and I want to commend our clinical team for the tremendous dedication they have shown in advancing our Phase 3 program for ONS-5010,” added Terry J. Dagnon, Chief Operating Officer. “ONS-5010, if approved, has the potential to help address the unmet medical needs of patients for a responsibly priced, FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases.”

Click here to read the full press release.