Kala Pharma application for new drug INVELTYSTM set to be evaluated by FDA

Biopharmaceutical company Kala pharmaceuticals into development and commercialization of product candidates incorporating the usage of MPP technology declared that the New drug application for INVELTYSTM (KPI-121 1%) will be assessed by the FDA that will aid treatment of inflammation and pain in patients who have undergone ocular surgery. The FDA states that the application is complete enough to commence substantive review setting an action date as laid down in the Prescription Drug User Fee Act (PDUFA) of August 24, 2018. It is also noteworthy that the brand name has also been sanctioned.

Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. said “The FDA’s acceptance of the NDA filing for INVELTYS is another significant milestone for the company towards our mission of developing innovative treatments for ocular conditions using our MPP technology.”

The Mucus Penetrating Particle (MPP) technology will enable the development of INVELTYS. MPPs are selectively sized nanoparticles with proprietary coatings that Kala claims to remarkably enhance drug penetration and distribution in ocular tissues as testified in the pre-clinical studies where MPPs increased delivery into ocular tissues by surging penetration through the tear film mucus.

Two Phase 3 clinical trials revealed positive data for INVELTYS that was administered twice a day to patients having undergone cataract surgery. The trials attained immense 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 compared to placebo. It was also noticeable that administration of INVELTYS witnessed no adverse events thus marking high tolerance levels.