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NDA for Inveltys to treat postoperative inflammation, pain accepted
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The FDA has accepted a new drug application for Inveltys, a product candidate for the treatment of inflammation and pain in ocular surgery patients, according to a press release from Kala Pharmaceuticals.
If approved, Inveltys (KPI-121 1%) would be the first twice-daily ocular corticosteroid indicated for the treatment of postoperative ocular inflammation and pain, as all other drugs currently on the market are indicated for four times a day, the release said.
It uses Kala’s mucus-penetrating particle technology to enhance drug penetration and distribution in ocular tissues.
In two phase 3 clinical trials, Inveltys showed statistical significance for its primary efficacy endpoints of complete resolution of inflammation and pain at day 8 through day 15 compared with placebo, according to the release.
Inveltys has a Prescription Drug User Fee Act date of Aug. 24.