Kala Pharmaceuticals submits NDA for Inveltys
Kala Pharmaceuticals has submitted a new drug application to the FDA for Inveltys, its inflammation and pain treatment candidate for those who have undergone ocular surgery, according to a company press release.
Inveltys (KPI-121 1%) is a twice-a-day topical ocular corticosteroid that utilizes the company’s proprietary mucus penetrating particle (MPP) technology, selectively sized nanoparticles with coatings that enhance drug penetration and distribution in ocular tissues, the release said.
Two phase 3 clinical trials, in which Inveltys achieved statistical significance over placebo in the resolution of inflammation and pain, support the NDA filings.
“We believe that our MPP technology has the potential to not only improve the postoperative care of patients undergoing ocular surgery, but also help advance care in other ophthalmic indications such as dry eye disease using our KPI-121 0.25% product candidate. We expect to receive topline results from the phase 3 clinical program for KPI-121 0.25% in patients with dry eye disease by the end of 2017,” Mark Iwicki, chairman and CEO of Kala Pharmaceuticals, said in the release.