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FDA OKs Expanded Indication For Ocular Therapeutix Eye Pain Drug Months Ahead Of Schedule

Shanthi Rexaline

Micro-cap biotech Ocular Therapeutix Inc (NASDAQ: OCUL) announced Friday that it received FDA approval for an expanded indication for its eye pain drug.

What You Need to Know

Ocular said the FDA approved its sNDA to expand the usage of Dextenza to include the treatment of ocular inflammation following ophthalmic surgery.

With the approval for the additional indication, Dextenza is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.

The FDA had approved the drug for eye pain in November. 

Dextenza is a corticosteroid and is inserted into the lower lacrimal punctum in canaliculus by the physician following ophthalmic surgery.

A single dose of the drug releases 0.4mg of dexamethasone for up to 30 days following insertion.

The FDA communicated its acceptance of the sNDA on April 2, with the PDUFA date set for Nov. 10. The approval came about five months ahead of the scheduled date.

What Next

Ocular is also evaluating Dextenza in a Phase 3 trial for allergic conjunctivitis.

"With our C-Code and pass-through payment status effective on July 1, the expanded indication gives us tremendous momentum as we approach our commercial launch," CEO Antony Mattessich said in a statement. 

At last check, Ocular shares were up 5.65% at $4.36. 

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