Topical treatment for RVO, DME advances

Kala Pharmaceuticals announced the initiation of a phase 2 clinical trial of its nanotechnology-based platform in patients with retinal vein occlusion (RVO) and diabetic macular edema (DME), a strategy with the potential to deliver drugs to the back of the eye using eye drops.

The company also initiated a phase 2 trial using its nanotechnology platform, the Mucus Penetrating Particle (MPP) platform, in meibomian gland disease.

“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,” said Jeffery S. Heier, MD, director of Vitreoretinal Service at Ophthalmic Consultants of Boston and one of two lead investigators in the trials. “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.”

The RVO/DME study is a single-masked, randomized trial expected to include up to 20 patients at two centers in the United States. It will investigate the safety and efficacy of two concentrations of loteprednol etabonate MPP (LE-MPP) drug product in patients with measurable intraretinal or subretinal fluid secondary to RVO or DME.

The double-masked, randomized, meibomian gland disease trial will examine the safety and efficacy of LE-MPP compared with vehicle, and is expected to include approximately 150 patients in up to 10 centers in the United States.

In June, Kala initiated two other trials to evaluate LE-MPP: A phase 3 trial to evaluate its safety and efficacy in managing inflammation and pain associated with cataract surgery, and a phase 2 trial investigating its use in patients with dry eye disease.