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Pharma & Biotech

US FDA to review Ocular Therapeutix’s resubmitted NDA for eye-pain drug Dextenza

The Massachusetts-based biotech’s Dextenza has completed Phase 3 evaluation for the treatment of pain, inflammation after eye surgery

Shares of Ocular Therapeutix Inc. (NASDAQ:OCUL) climbed Thursday after the drug maker announced that the US Food and Drug Administration (FDA) had accepted its new drug application for an eye-pain drug called Dextenza.

Ocular Therapeutix stock gained 2.3% to US$6.41.

The Bedford, Massachusetts-based biotech’s pain medication Dextenza is inserted through the eye lid and delivers a 0.4 mg dose of dexamethasone to the eye for up to 30 days without preservatives.

Dextenza has completed Phase 3 evaluation for the treatment of ocular pain and inflammation following eye surgery.

“We are pleased with the recent news that the FDA has formally accepted our resubmission of the Dextenza new drug application,” said Ocular Therapeutix CEO Antony Mattessich. “This marks one more important step towards our goal of bringing this important new treatment to the market.”

Dextenza is also in Phase 3 clinical development for allergic conjunctivitis.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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