KPI-121 0.25% safe, well-tolerated in patients with dry eye disease
The results of four randomized, double-masked, vehicle-controlled trials showed KPI-121 0.25% is safe and well tolerated with no unexpected treatment-related adverse events in patients with dry eye disease, according to a study.
“The clinical development program for KPI-121 0.25%, which will be marketed as Eysuvis if approved, is the largest to date for a dry eye product. In over 2,800 patients across the four trials, KPI-121 0.25% administered up to 28 days appeared safe and well tolerated with no unexpected adverse events,” Kim Brazzell, PhD, chief medical officer for Kala Pharmaceuticals, told Healio/OSN.
Researchers evaluated the safety results of KPI-121 0.25% (Kala Pharmaceuticals), an ophthalmic nanoparticle suspension of loteprednol etabonate, in patients with dry eye disease in one phase 2 and three phase 3 randomized trials. The trials included 1,430 patients who received KPI-121 four times a day for 2 weeks or longer compared with 1,438 subjects who received vehicle drops.
Adverse events were reported by 12.9% of participants receiving KPI-121 compared with 10.4% of participants receiving vehicle drops. The most reported adverse event was instillation site pain, reported by 5.2% of participants receiving KPI-121 and 4.4% of participants receiving vehicle drops.
In the four trials, 0.5% of KPI-121 participants reported serious adverse events and 0.1% of vehicle drop participants reported serious adverse events.
In addition, 0.6% of KPI-121 participants experienced an IOP elevation, defined as an increase from baseline of greater than 5 mm Hg that resulted in an IOP of 21 mm Hg or higher, compared with 0.2% of vehicle drop participants.
“We believe the excellent safety and tolerability of Eysuvis will resonate well with the medical community for the short-term treatment of the signs and symptoms of dry eye disease,” Brazzell said.