Outlook Therapeutics (NASDAQ:OTLK) Inc said it has voluntarily withdrawn the biologics license application (BLA) for its ophthalmic formulation of bevacizumab (ONS-5010 or Lytenava) after the US Food and Drug Administration (FDA) requested additional information.
The company added that it is actively working to respond to the FDA’s request and plans to resubmit a revised BLA by September. A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce.
“We remain confident in ONS-5010 and its potential to be the first FDA-approved ophthalmic formulation of bevacizumab that avoids the public health risk to patients of off-label treatment of bevacizumab that was never approved for any ophthalmic indications,” Outlook CEO Russell Trenary said in a statement.
READ: Outlook Therapeutics ends fiscal 2Q with $58.4M in cash as it ramps up pre-commercial activities for wet AMD treatment Lytenava
“We are continuing to have productive discussions with the FDA and are committed to providing the additional information necessary to support the application,” he added. “We look forward to a successful resubmission and ultimately the potential approval of ONS-5010 for the treatment of wet AMD. We also look forward to a future where virtually all retina patients treated with bevacizumab are receiving an FDA-approved ophthalmic therapy.”
Outlook previously submitted its BLA to the FDA in March 2022, based on a compilation of the data from its previously completed clinical trials – NORSE ONE, NORSE TWO and NORSE THREE.
NORSE ONE was a proof-of-concept and clinical experience trial, which helped validate the protocols and approach for NORSE TWO, the pivotal safety and efficacy trial. NORSE TWO delivered statistically significant and clinically relevant data for the primary and all secondary endpoints. NORSE THREE was an open-label supplementary safety trial conducted to ensure that a sufficient number of patients had been dosed with ONS-5010 ophthalmic bevacizumab to support the regulatory submission, the company said.
Ultimately, Outlook is hoping to become the first and only company to commercialize an FDA-approved ophthalmic formulation of bevacizumab, otherwise known as the cancer drug Avastin, for use in the damaging retinal condition known as wet age-related macular degeneration, or wet AMD. The chronic eye disorder leaks fluid into the retina and causes blurred vision or blind spots, which can eventually lead to loss of sight.
Treatment options include anti-vascular endothelial growth factor (anti-VEGF) drugs that can cost up to $2,000 a sitting and cause painful side effects like intraocular inflammation, the company said.
That makes bevacizumab an attractive option at around $100 per shot, but there are risks to using if off label: potencies can vary, there are no physician standards on how to administer the drug, a syringe could malfunction, etc.
If the company can get ONS-5010 approved as the first ophthalmic formulation of bevacizumab, it is looking at a 12-year exclusivity period.
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