Nanoparticle drug reduces postop pain, inflammation

Kala Pharmaceuticals announced that its nanoparticle-based treatment can reduce inflammation and pain within one week after cataract surgery with just twice daily dosing.

A phase 3 clinical trial of the company’s nanoparticle  loteprednol etabonate mucus-penetrating particle product candidate, KPI-121, evaluated 2 dosing regimens (0.25% 4 times daily or 1.0% 2 times daily) compared with vehicle in 380 patients undergoing cataract surgery.

At day 8, patients treated with either dosing regimen experienced a significant improvement in both pain and inflammation compared to vehicle.

“Kala’s clinical data demonstrating that twice daily dosing of KPI-121 was effective in reducing inflammation and pain within one week of initiation of treatment are very encouraging, as current corticosteroids approved in the United States for this use are indicated for four times a day dosing during the first two weeks of therapy,” said Terry Kim, MD, professor of ophthalmology at Duke University.

Kala is also investigating a 0.25% formulation of KPI-121 for dry eye and meibomian gland disease. Phase 2 results showed that it could significantly reduce conjunctival hyperemia, but it did not result in a significant reduction in ocular discomfort.

Although KPI- 121 did not significantly improve ocular discomfort, the trial showed promising trends toward improvement in this and other symptom endpoints, particularly in patients with more severe baseline ocular discomfort. KPI-121 was generally well tolerated, with no significant treatment-related safety findings observed during the course of the trial.

The only treatment-emergent adverse event reported in greater than 3% of patients was instillation site pain, which was reported in 6.9% of patients treated with KPI-121 compared to 3.8% of patients treated with vehicle.

“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,” said said Kim Brazzell, PhD, chief medical officer of Kala.