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Ocular Therapeutix submits NDA for Dextenza to treat postop ocular pain

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Ocular Therapeutix submitted a new drug application to the FDA for Dextenza to treat ocular pain after ophthalmic surgery, according to a press release.

“This represents Ocular Therapeutix’s first NDA filing with the FDA and is an important development milestone as we advance our broad-based programs for the treatment of ocular diseases and conditions through clinical development and potential commercialization pending FDA approval,” Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix, said in the release.

The submission is based on data from one phase 2 and two phase 3 clinical trials.

Ocular Therapeutix plans to submit a supplement to the NDA for the treatment of post-surgical inflammation as part of its label expansion strategy for Dextenza (sustained-release dexamethasone 0.4 mg) pending results of a third phase 3 trial that is expected to start this year.

The company also recently completed enrollment in a phase 3 trial of Dextenza for the treatment of allergic conjunctivitis. Top-line efficacy data are expected in the fourth quarter, the release said.