FDA accepts new drug application for Kala Pharma's dry eye drug KPI-121 (0.25%)

dry eye disease (DED) is a chronic, intermittent, multifactorous disease that affects tear strains and eye watches and can lead to instability, inflammation, discomfort, visual impairment, and eye surface damage, Kala Pharma(http:// announcedthat the U.SFood andDrug(http://Administration (
FDA(http://) has accepted an application for theof the http://
of the drug KPI-121 (0.25%) for the dry eye disease drug KPI-121 (0.25%) for the temporary relief of symptoms and signs of dry eye diseaseThe FDA has designated the TARGET date for the NDA Prescription Drug User Charge (PDUFA) as August 15, 2019If approved, KPI-121 (0.25%) is expected to become the firstproduct(http://for temporary relief of symptoms and signs of dry eye disease, including the treatment of dry eye flaresKPI-121 (0.25%)KPI-121 (0.25%) used Kala's proprietary AMPPLIFY drug delivery technology to enhance penetration of eye target tissueIn preclinical studies, AMPPLIFY technology delivered three times more LE to eye tissues by facilitating the penetration of tear cell mucoproteins than the current market for le.biota (LE)AMPPLIFY technology has also been applied to Kala's other eye product, Inveltys (1%), the first 2-times-daily corticosteroid product, which was approved by the U.SFDA in August 2018 to treat inflammation and pain after ophthalmologyCurrently, all other eye steroid drugs on the market are approved only four times a day, and this more frequent dosing requirement may cause problems for doctors and patientsrelated studiesKPI-121 (0.25%) NDA submissions are based on data from a Phase II study and two Phase III Efficacy and Safety Studies (STRIDE-1, STRIDE-2)These studies were studied in more than 2,000 cases of dry eye diseaseOn FDA recommendations, Kala also launched Phase 3 Phase III clinical study STRIDE-3 in July 2018 to evaluate KPI-121 (0.25%) for temporary relief of dry eye signs and symptomsThe company expects to release data for Phase 3 Phase III in the fourth quarter of 2019Kala PharmaKala Pharma, a Massachusetts-based bio
Pharmaceutical(http:// company, focuses on developing and commercializing new drugs to treat eye diseases with its proprietary nanoparticle-based mucus penetration particles (MPP) drug delivery technology