Kala Pharmaceuticals starts Phase II trial of LE-MPP in patients with RVO, DME

In this trial, the company will evaluate the efficacy and safety of 1% LE-MPP and 0.25% LE-MPP dosed four times daily in patients having measurable intraretinal or subretinal fluid secondary to RVO or DME.

About 20 patients from two US centers are expected to be enrolled in this single-masked randomized Phase II trial.

Ophthalmic Consultants of Boston Vitreoretinal Service director Jeffery Heier and Retina-Vitreous Associates Medical Group doctor David Boyer serve as the two lead investigators in this exploratory trial.

Kala chief medical officer Kim Brazzell said the company is happy about the progress of its lead nanotechnology-based program, LE-MPP, with four active clinical trials.

"With the initiation of our latest trial in RVO and DME, Kala is making significant progress toward demonstrating the unique ability of Kala’s MPP platform to deliver drugs to the back of the eye following topical administration," Brazzell said.

Additionally, the company has begun a Phase II clinical trial (KPI-121-C-003) of LE-MPP in patients with meibomian gland disease (MGD).

In this double-masked, randomized Phase II (KPI-121-C-003) trial of LE-MPP, the company will evaluate the safety and efficacy of 0.25% LE-MPP compared to vehicle dosed four times daily in subjects with meibomian gland disease.

Around 150 patients in up to 10 centres in the US will be enrolled in the KPI-121-C-003 trial.