Monitoring Board Gives Positive Recommendation On Ocugen's Eye Disease Gene Therapy Trial

  • The independent Data and Safety Monitoring Board (DSMB) for Ocugen Inc's OCGN Phase 1/2 trial of OCU400 has recommended that the study proceeds with enrolling additional subjects.
  • The recommendation follows the review of safety data based on dosing to date.
  • OCU400 is the Company's flagship modifier gene therapy candidate for Retinitis Pigmentosa (RP) treatment.
  • Last week, the FDA warned Ocugen to pay a $10,000 fine for failing to report the results from the Phase 3 study of brimonidine tartrate nanoemulsion eye drop to treat dry eye disease.
  • Also Read: Why Ocugen Shares Are Trading Higher Today.
  • The trial was completed in May 2019. The Company said in an SEC filing in November 2019 that the Phase III trial has been completed, "and although the study showed that OCU310 is well tolerated, as demonstrated by no adverse events regarding as 'severe,' it did not meet its co-primary endpoints for symptoms and signs."
  • The FDA is now giving Ocugen until May 15 to post the results from the trial.
  • Price Action: OCGN shares are up 3.96% at $2.50 during the market session on the last check Monday.
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