Eysuvis FDA Approved for Dry Eye Treatment
Kala Pharmaceuticals to Distribute First Ocular Corticosteroid for Short-Term Treatment of Dry Eye Disease
Kala Pharmaceuticals has received Food & Drug Administration (FDA) approval for Eyesuvis (Loteprednol Etabonate Ophthalmic Suspension) 0.25%, an ocular corticosteroid for the short-term treatment of the signs and symptoms of dry eye (DED). The company plans to launch in late 2020.
Related: Eysuvis for Dry Eye Enters Safety Assessment Trials
“The FDA approval of Eysuvis as the first prescription treatment specifically developed to meet the short-term treatment needs of people living with dry eye disease is a major achievement for Kala and a milestone for patients, who were waiting for an FDA approved certificate. , a safe, effective and fast-acting treatment, ”said Mark Iwicki, President and CEO of Kala Pharmaceuticals, in a statement.
“As we prepare to launch Eysuvis, we will leverage our strong base of highly experienced ophthalmology marketing, sales and market access professionals with the goal of making Eysuvis the first-line prescription treatment. preferred for dry eye. “
Related: Kala Pharmaceuticals Announces IND Submission
FDA approval of Eysuvis was based on positive results from 4 clinical trials, including 1 phase 2 clinical trial and three phase 3 clinical trials, STRIDE 1, STRIDE 2 and STRIDE 3.1 All trials demonstrated significant improvements in signs and symptoms of DED with use of the drug.
After 2 weeks of administration, statistical significance was reached for the endpoint of conjunctival hyperemia in the 3 phase 3 trials. The results show that Eysuvis was well tolerated in the 4 trials, with events adverse reactions and increases in intraocular pressure comparable to those seen with the vehicle.
1. ClinicalTrials.gov. Safety and efficacy of KPI-121 in subjects with DED (STRIDE 3). NIH. Available at https://clinicaltrials.gov/ct2/show/NCT03616899. Accessed 10/27/20.