Outlook Therapeutics (OTLK) - Get Outlook Therapeutics, Inc. Report climbed Tuesday after the biopharmaceutical company reported positive results for its treatment of neovascular age-related macular degeneration, or wet AMD.
Shares of the Iselin, N.J., company were surging 35% to $3.04.
Outlook Therapeutics said it saw "positive clinical and highly statistically significant top-line results" from its Phase 3 NORSE TWO safety and efficacy trial evaluating ONS-5010/Lytenava, or bevacizumab.
C. Russell Trenary III, president and CEO, said in a statement that the successful completion of this trial was the final step needed in the company's clinical evaluation of ONS-5010 to enable it to submit a Biologics License Application to the Food and Drug Administration in the first quarter of next year.
In anticipation of potential FDA marketing approval in 2022 for ONS-5010, Outlook Therapeutics said it has begun commercial launch planning. The company said it expects ONS-5010 "if approved, to be a safe and cost-effective choice for patients, payors and clinicians worldwide for retinal indications."
"Currently there are a vast number of off-label injections of bevacizumab to treat retinal disease in the United States, and we want to offer an alternative for patients and retinal surgeons that is approved and formulated and packaged specifically for wet AMD," Trenary said.
The trial enrolled a total of 228 subjects with wet AMD across 39 clinical trial sites in the United States. Participants were treated for 12 months.
The primary endpoint for the study was the proportion of patients who gain at least 15 letters in the best corrected visual acuity (BCVA) at 11 month. The key secondary endpoint was the mean change in the BCVA through 11 months.