Kala pursues study for lower-dose topical corticosteroid

Kala Pharmaceuticals has submitted an Investigational New Drug application to the FDA to initiate phase 3 clinical studies for a nano-suspension preparation of a topical corticosteroid for treating inflammation and pain following cataract surgery.

The objective of the upcoming clinical trial is to demonstrate that the company’s loteprednol etabonate ophthalmic nano-suspension product has similar efficacy to that of other steroid-based treatments with less frequent (twice-daily) dosing while maintaining the safety profile of current loteprednol etabonate products.

“A topical corticosteroid with superior penetration and pharmacokinetics and a more favorable dosing regimen would be a welcome alternative to current treatment regimens,” said Guillaume Pfefer, PhD, Kala’s president and CEO.

The drug uses the company’s proprietary Mucus Penetrating Particle (MPP) technology, designed to allow therapeutic agents to pass through the mucus layer of the ocular surface, facilitating penetration into deeper tissues of the eye, including the aqueous humor and retina.

“It’s exciting to see nanoparticle technology moving to the forefront of the ophthalmology field,” said Terry Kim, MD, professor of ophthalmology at Duke University Eye Center. “By combining small particle size and state-of-the-art surface engineering techniques, physicians and patients should benefit from a variety of new and improved therapeutic options across ophthalmic disease states.”

The company plans to initiate clinical programs with lower doses of the drug for dry eye disease, blepharitis and retinal disease later this year.