The U.S. Food and Drug Administration rejected Kala Pharmaceuticals Inc.'s application for its KPI-121 0.25% therapy to treat symptoms of dry eye disease.
Dry eye disease occurs when tears do not provide adequate lubrication for the eyes. Symptoms include irritation, redness, discharge, fatigued eyes and blurred vision.
The company's application was backed by data from one phase 2 and two phase 3 studies that evaluated the efficacy and safety of the topical treatment in about 2,000 patients with the disease.
In its response letter to the company, the FDA said efficacy data from an additional clinical trial will be needed to support resubmission of the application.
Kala plans to use data from an ongoing late-stage study named Stride 3 to respond to the FDA's letter. The study will evaluate KPI-121 0.25% against placebo in 900 patients with dry eye disease who will be dosed four times a day for two weeks. The company initiated the trial in July 2018 at the FDA's recommendation.
Watertown, Mass.-based Kala is targeting top-line data from the study by the end of 2019 and plans to resubmit its application for KPI-121 0.25% during the first half of 2020. The company expects resubmission to be subject to a six-month review.
"We remain confident in the potential of KPI-121 0.25% to be the first approved product for the temporary relief of the signs and symptoms of dry eye disease," said Kim Brazzell, chief medical officer at Kala.
The company's shares on the Nasdaq closed 9.98% down to $4.60 on Aug. 8.