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Therapeutic perspectives (OTLK) – Get the Outlook Therapeutics, Inc. climbed Tuesday after the biopharmaceutical company reported positive results for its treatment of age-related neovascular macular degeneration, or wet AMD.
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Outlook Therapeutics said it has seen “positive and highly statistically significant clinical results” from its NORSE TWO Phase 3 safety and efficacy trial evaluating ONS-5010 / Lytenava, or bevacizumab.
C. Russell Trenary III, president and chief executive officer, said in a statement that successful completion of this trial was the last step necessary for the company’s clinical evaluation of ONS-5010 to enable it to submit an application. of Biologics License to the Food and Drug Administration. in the first quarter of next year.
In anticipation of a possible FDA market approval in 2022 for ONS-5010, Outlook Therapeutics said it has begun planning for the commercial launch. The company said it expects ONS-5010 “if approved, to be a safe and cost-effective choice for patients, payers and clinicians worldwide for retinal indications.”
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“Currently, there are a large number of off-label injections of bevacizumab to treat retinal disease in the United States, and we want to provide an alternative to patients and retinal surgeons that is approved, formulated and packaged specifically for wet AMD, ”Trenary said. .
The trial enrolled a total of 228 subjects with wet AMD at 39 clinical trial sites in the United States. The participants were treated for 12 months.
The primary endpoint of the study was the proportion of patients who gain at least 15 letters in best corrected visual acuity (BCVA) at 11 months. The key secondary endpoint was the 11-month mean change in BCVA.
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