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.
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