Kala Pharmaceuticals Inc. is seeking approval from the U.S. Food and Drug Administration for its medicine KPI-121 0.25%, which could become the first approved therapy for treating symptoms of dry eye disease.
Dry eye disease occurs when the tears are not able to provide adequate lubrication for the eyes. The symptoms include irritation, redness, discharge, fatigued eyes and even blurred vision. The Waltham, Mass.-based company said that about 33 million Americans have dry eye disease and about 90% of these patients have flares associated with the condition.
The company said its topical treatment KPI-121 0.25% could offer a favorable management option for these dry eye flares and other dry eye-associated conditions.
Kala submitted an application to the FDA for the drug's approval based on positive data from three trials, including one phase 2 and two phase 3 trials in 2,000 patients with dry eye diseases, according to an Oct. 16 press release. The company said a third phase 3 trial is underway, dubbed Stride 3, to evaluate KPI-121 0.25% for temporary relief of the symptoms of dry eye disease.
In August, the biopharmaceutical company secured FDA approval for its drug Inveltys as a treatment for pain after eye surgery.