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.