A 1% formulation of loteprednol etabonate, under the brand name Inveltys, was just approved by the FDA with an indication for treatment of inflammation and pain following ocular surgery. Inveltys is manufactured by Kala Pharmaceuticals. The company says this is the first twice-daily topical corticosteroid approved for this indication, as others are dosed QID. That distinction “may improve compliance and prove less burdensome for patients,” according to a company press release.
The drug uses what Kala calls ‘mucus-penetrating particle’ technology to enhance penetration, an advantage the company says was demonstrated in preclinical studies. Inveltys successfully completed two Phase III clinical trials and achieved statistical significance for both primary efficacy endpoints in both, with no treatment-related serious adverse events, according to the release.