Kala Gains FDA Approval of Inveltys for Treatment of Postsurgical Inflammation, Pain

August 24, 2018: By Joan McKenna

Kala PharmaceuticalsKala Pharmaceuticals announced Aug. 23 that the US FDA approved Inveltys for the treatment of inflammation and pain following ocular surgery.

Inveltys (loteprednol etabonate ophthalmic suspension) 1% is the first twice-daily ocular corticosteroid approved for this indication, while other ocular steroids are labeled for dosing four times a day, Kala said.

The Waltham, Massachusetts, company said it plans to hire a sales force that will focus on eye care professionals in the US, and it expects to launch Inveltys at the beginning of 2019.

Inveltys uses Kala’s proprietary mucus-penetrating particle (MPP) technology, selectively sized nanoparticles with proprietary coatings, to enhance penetration into target tissues of the eye.

Inveltys successfully completed two Phase III clinical trials and achieved statistical significance in resolution of pain and inflammation compared with placebo in both trials, Kala said. In each of these trials, Inveltys was well tolerated with no treatment-related serious adverse events observed.

Kala is also developing a dry eye candidate and expects to submit a new drug application to the FDA in 2018.

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