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Kala initiates phase 2 trials for RVO, DME treatment
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Kala Pharmaceuticals announced the initiation of a phase 2 clinical trial of KP-121, its loteprednol etabonate mucus penetrating particle platform, in patients with retinal vein occlusion and diabetic macular edema.
The company is also launching a phase 2 clinical trial of loteprednol etabonate mucus penetrating particle (LE-MPP) in patients with meibomian gland disease, according to a press release.
The phase 2 clinical trial in patients with retinal vein occlusion (RVO) and DME will investigate the safety and efficacy of 1% LE-MPP and 0.25% LE-MPP used four times daily in patients with measurable intraretinal or subretinal fluid secondary to RVO or DME. The single-masked, randomized trial is expected to include up to 20 patients at two centers in the United States, according to the release.
The phase 2 clinical trial in patients with meibomian gland disease will also look at the safety and efficacy of 0.25% LE-MPP compared with vehicle dosed four times daily in patients with the disease. The double-masked, randomized trial is expected to include approximately 150 patients in up to 10 centers in the U.S., according to the release.
The new trials follow two other LE-MPP studies launched in June: a phase 3 trial evaluating the drug’s safety and efficacy in the management of cataract surgery-induced pain and inflammation, and a phase 2 trial evaluating low-dose LE-MPP in patients with dry eye disease.