Kala studying nanotechnology for RVO, DME, and MGD

Waltham, MA-Kala Pharmaceuticals has initiated a phase II clinical trial to evaluate a nanopartical platform in patients with intraretinal or subretinal fluid secondary to retinal vein occlusion (RVO) or diabetic macular edema (DME).

In addition, the company has initiated a phase II clinical trial to study the platform-KP-121, loteprednol etabonate MPP (LE-MPP)-in patients with meibomian gland disease (MGD).

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“We are excited about the progress of our lead nanotechnology-based program with four active clinical trials,” said Kim Brazzell, PhD, chief medical officer of Kala. “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.”

In the phase II trial for RVO and DME-a single-masked randomized trial-Kala 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 secondary to RVO or DME.

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In the phase II trial for MGD-which will be a double-masked, randomized trial-Kala will study the safety and efficacy of 0.25% LE-MPP compared with vehicle dosed four times daily in patients with MGD.

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In June, Kala initiated dosing in two other trials to evaluate the platform:

·      A phase III trial to evaluate its safety and efficacy in managing inflammation and pain associated with cataract surgery.

·      A phase II trial to investigate its safety and efficacy in a low-dose form in patients with dry eye disease.

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