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Ocular Therapeutix seeks expanded US FDA approval for eye insert Dextenza

Ocular Therapeutix Inc. is seeking approval from U.S. Food and Drug Administration to use Dextenza for ocular inflammation following eye surgery.

Dextenza, an insertable eye drug delivery system, is already approved by the FDA to treat eye pain following ophthalmic surgery.

The eye insert releases a 0.4-milligram dose of dexamethasone for up to 30 days after being placed inside each eyelid.

Bedford, Mass.-based Ocular Therapeutix expects the FDA review for its supplemental new drug application to be completed in the second half of 2019.

The application is supported by data from two late-stage trials, which enrolled cataract surgery patients to evaluate Dextenza against a vehicle control — just the neutral substance used to dissolve active ingredients. Ocular Therapeutix said Dextenza showed statistical significance over the vehicle control in terms of absence of ocular pain and inflammation.

Ocular Therapeutix develops and sells therapies for diseases and conditions of the eye.