Kala Pharmaceuticals announced that it has submitted a new drug application (NDA) to the FDA for Inveltys (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery. If approved, Kala expects Inveltys would be the first twice-daily ocular corticosteroid indicated for the treatment of postoperative ocular inflammation and pain. The brand name for KPI-121 1%, Inveltys, has been conditionally approved by the FDA.
Inveltys utilizes Kala’s proprietary Mucus Penetrating Particle (MPP) technology. MPPs are selectively-sized nanoparticles with proprietary coatings that significantly enhance drug penetration and distribution in ocular tissues. In pre-clinical studies, MPPs increased delivery into ocular tissues more than three-fold by facilitating penetration through the tear film mucus.
“Inveltys administered twice-a-day to patients following cataract surgery demonstrated statistically significant resolution of both inflammation and pain in each of two phase 3 clinical trials,” Kim Brazzell, PhD, Chief Medical Officer of Kala Pharmaceuticals, said in a company news release. “Based on these results, as well as its safety profile and twice-daily dosing, we believe that Inveltys would be a valuable treatment option for doctors and patients.”
The NDA filing is supported by positive data from two phase 3 trials. The first phase 3 clinical trial was designed to evaluate Inveltys administered twice-a-day and KPI-121 0.25% administered four times a day for 14 days following cataract surgery. Statistical significance was achieved for the primary efficacy endpoints of complete resolution of inflammation at day 8 maintained through day 15 with no need for rescue medication compared to placebo and complete resolution of pain at day 8 maintained through day 15 with no need for rescue medications compared to placebo with both Inveltys and KPI-121 0.25%. In May 2017, Kala announced topline results from the second, confirmatory phase 3 clinical trial with Inveltys. Compared to placebo, administration of Inveltys twice-a-day for 14 days achieved statistical significance for both primary efficacy endpoints of complete resolution of inflammation at day 8 maintained through day 15 with no need for rescue medication compared to placebo and complete resolution of pain at day 8 maintained through day 15 with no need for rescue medications and all secondary endpoints. Inveltys was found to be well tolerated with no treatment-related serious adverse events observed during the course of either trial.
“The filing of the NDA for Inveltys marks a major milestone for Kala in advancing our mission of developing treatments for eye conditions using our MPP technology,” Mark Iwicki, Chairman and Chief Executive Officer of Kala Pharmaceuticals, said in the news release. “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.”