Kala announces positive results in phase 2 dry eye trial

Kala Pharmaceuticals Inc. announced top-line results in a phase 2 clinical trial of KPI-121 in patients with dry eye disease, the company announced in a press release.

According to the release, KPI-121, a novel nanoparticle formulation of loteprednol etabonate that uses Kala's mucus-penetrating particle technology, met its primary sign endpoint in demonstrating statistical superiority of conjunctival hyperemia reduction.

“The achievement of statistical significance for the primary sign endpoint in this relatively small trial is an extremely important accomplishment,” Kim Brazzell, PhD, chief medical officer of Kala, said in the release. “We are encouraged by the promising trends seen in the trial’s symptom endpoints, and we believe these data will inform further clinical development by us for this important disease.”

As detailed in the release, the phase 2 clinical trial was designed as a multicenter, randomized, double-masked, parallel-group trial with 150 dry eye patients. The trial assessed 0.25% KPI-121 in comparison with vehicle. Patients used their respective medications four times a day for 28 days.

Results showed that patients who used KPI-121 demonstrated statistical significance in bulbar conjunctival hyperemia, the primary clinical sign endpoint, on day 29 of the trial. Additionally, KPI-121 demonstrated promising improvement of the primary symptom endpoint of ocular discomfort as well as other symptom endpoints. No significant safety findings related to KPI-121 were observed, and the only significant number of patient-reported adverse events occurred in 6.9% of patients who said they experienced instillation site pain, according to the release.