Why Are Ocular Therapeutix Shares Trading Higher Today?

  • The FDA has approved Ocular Therapeutix Inc's OCUL supplemental application to broaden the Dextenza label.
  • The approval now adds an indication for ocular itching associated with allergic conjunctivitis. 
  • With the approval, Dextenza is the first FDA-approved, physician-administered intracanalicular insert to deliver a drug to treat ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days. 
  • Related content: Benzinga's Full FDA Calendar.
  • Dextenza originally received FDA approval in November 2018 for ocular pain following ophthalmic surgery, followed by an expansion of the label to include ocular inflammation in June 2019.
  • The efficacy of DEXTENZA for treating ocular itching associated with allergic conjunctivitis was based on three randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in subjects with a positive history of ocular oculars allergies and positive skin test reaction to perennial and seasonal allergens (n=255). 
  • Dextenza demonstrated lower mean ocular itching scores than the vehicle group at all time points throughout the study duration of up to 30 days. It was observed to have a favorable safety profile and be generally well-tolerated.
  • Related: Ocular Therapeutix, Regeneron Cull Aflibercept Agreement For Retinal Diseases
  • Price Action: OCUL shares are up 15% at $11.21 during the market session on the last check Monday.
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