FDA News

FDA approves Dextenza for treatment of ocular inflammation

Dextenza, the first FDA-approved intracanalicular insert for the treatment of postoperative ocular pain, is now also approved for the treatment of ocular inflammation after ophthalmic surgery, Ocular Therapeutix announced in a press release.

The FDA approved a supplemental new drug application for Dextenza (dexamethasone ophthalmic insert 0.4 mg) to include the treatment of ocular inflammation after ophthalmic surgery as an additional indication. Dextenza received FDA approval for postoperative ocular pain in November 2018.

The approval was supported by three phase 3 randomized, vehicle-controlled trials comparing outcomes for patients who received Dextenza or vehicle upon completion of cataract surgery. A statistically significant level of patients receiving Dextenza were pain-free on postoperative day 8 compared with patients receiving vehicle. At day 14, in two of three studies, more Dextenza patients had an absence of anterior chamber cells compared with vehicle patients.

“We could not be more excited about both the approval and its earlier-than-expected timing,” Antony Mattessich, Ocular Therapeutix president and CEO, said in a press release. “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.”

Dextenza, the first FDA-approved intracanalicular insert for the treatment of postoperative ocular pain, is now also approved for the treatment of ocular inflammation after ophthalmic surgery, Ocular Therapeutix announced in a press release.

The FDA approved a supplemental new drug application for Dextenza (dexamethasone ophthalmic insert 0.4 mg) to include the treatment of ocular inflammation after ophthalmic surgery as an additional indication. Dextenza received FDA approval for postoperative ocular pain in November 2018.

The approval was supported by three phase 3 randomized, vehicle-controlled trials comparing outcomes for patients who received Dextenza or vehicle upon completion of cataract surgery. A statistically significant level of patients receiving Dextenza were pain-free on postoperative day 8 compared with patients receiving vehicle. At day 14, in two of three studies, more Dextenza patients had an absence of anterior chamber cells compared with vehicle patients.

“We could not be more excited about both the approval and its earlier-than-expected timing,” Antony Mattessich, Ocular Therapeutix president and CEO, said in a press release. “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.”