Outlook Therapeutics Shares Pop After Filing US Application For Its Lead Eye Disease Candidate

Outlook Therapeutics Inc OTLK has re-submitted its marketing application to the FDA, seeking approval for ONS-5010 for wet age-related macular degeneration (wet AMD).
In anticipation of potential FDA approval in 2023, Outlook Therapeutics has continued its commercial launch planning.
The company voluntarily withdrew its application in May after the FDA requested additional information to complete the filing.
The BLA re-submission is based on the totality of data from Outlook Therapeutics' wet AMD clinical program for ONS-5010, which consists of three trials.
Safety results across the first three NORSE trials demonstrated a strong benefit-to-risk safety profile. Across all three ONS-5010 registration trials, there was only one ocular inflammation adverse event.
As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplemental application for the product in a pre-filled syringe.
Outlook Therapeutics is conducting its NORSE SEVEN trial to compare the safety of ONS-5010 in vials versus ONS-5010 in pre-filled syringes.
NORSE SEVEN is expected to enroll approximately 120 subjects with visual impairment due to retinal disorders. Enrollment in the arm of the study receiving ONS-5010 in vials is complete.
Price Action: OTLK shares are up 9.82% at $1.23 on the last check Tuesday.