Kala Pharmaceuticals, Inc. Announces New Drug Application for INVELTYSTM (KPI-121 1%) Accepted for Review by the U.S. Food and Drug Administration
January 05, 2018 at 11:50 am
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Kala Pharmaceuticals, Inc. announced that the New Drug Application (NDA) for INVELTYSTM (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery, has been accepted for review by the United States Food and Drug Administration (FDA). The FDA, in its 74-day letter, indicates that the application is sufficiently complete to permit a substantive review and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018. If approved, INVELTYS is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative 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 Kala believes 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. The NDA submission for INVELTYS was supported by positive data from two Phase 3 clinical trials, in each of which INVELTYS administered twice-a-day to patients following cataract surgery 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 compared to placebo. INVELTYS was found to be well tolerated with no treatment-related serious adverse events observed during the course of either trial. INVELTYS™ (KPI-121 1%) is a twice-a-day corticosteroid for the treatment of inflammation and pain following ocular surgery. INVELTYS utilizes Kala’s proprietary Mucus-Penetrating Particle (MPP) technology to enhance penetration into target tissues of the eye. In pre-clinical studies, MPP increased delivery into ocular tissues more than three-fold by facilitating penetration through the tear film mucus. INVELTYS has successfully completed two Phase 3 clinical trials and achieved statistical significance for both primary efficacy endpoints in both trials. In each of these trials, INVELTYS was well tolerated with no treatment-related serious adverse events observed. Kala believes INVELTYS has a favorable profile compared to the standard of care for the treatment of inflammation and pain following ocular surgery, due to its twice-a-day dosing regimen and rapid onset of relief. A New Drug Application (NDA) for INVELTYS was accepted for review by the U.S. Food and Drug Administration (FDA) with a target action date of August 24, 2018.
KALA BIO, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in the research, development and commercialization of therapies for rare and severe diseases of the eye. The Companyâs biologics-based investigational therapies utilize its proprietary mesenchymal stem cell secretome (MSC-S) platform. The Companyâs product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived bio factors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. Its KPI-012 is used for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing. The Company is also engaged in the development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases.
KALA BIO, INC. 
