US-based Kala Pharmaceuticals has begun a Phase II clinical trial of its loteprednol etabonate MPP (LE-MPP) drug product KP-121 in patients with intraretinal or subretinal fluid secondary to retinal vein occlusion (RVO) or diabetic macular edema (DME).
In this trial (KPI-121-C-004), the company will investigate 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.
The company intends to enrol about 20 patients from two US centres in this single-masked, randomised Phase II trial.
Ophthalmic Consultants of Boston director of vitreoretinal service Jeffery Heier and Retina-Vitreous Associates Medical Group MD David Boyer will serve as the two lead investigators in the exploratory trial.
Kala Pharmaceuticals chief medical officer Kim Brazzell said: "We are excited about the progress of our lead nanotechnology-based programme, 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."
Additionally, the company has started a Phase II clinical trial (KPI-121-C-003) of LE-MPP in patients with meibomian gland disease (MGD).
In the double-masked, randomised Phase II (KPI-121-C-003) trial of LE-MPP, the company will assess the safety and efficacy of 0.25% LE-MPP compared with vehicle dosed four times daily in subjects with meibomian gland disease.
About 150 patients in up to ten centres in the US will be enrolled in the KPI-121-C-003 trial.
Heier said: "The potential to deliver substantial amounts of drug to tissues in the back of the eye using non-invasive topical administration would represent a significant advance in the treatment of retinal disease.
"Kala has generated promising preclinical data, and we look forward to further evaluating the company’s nanotechnology to determine if it offers potential for a less-invasive treatment for patients."