Kala submits IND for postop cataract surgery agent

Waltham, MA-Kala Pharmaceuticals Inc. has submitted an Investigational New Drug (IND) application to the FDA to initiate a phase III clinical program with its mucus-penetrating particle (MPP) technology-formulated loteprednol etabonate ophthalmic nano-suspension product (LE-MPP).

The drug is indicated for postoperative inflammation and pain following cataract surgery.

Kala’s MPP technology platform allows 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 is also designed to potentiate pharmacological effects within target tissues.

The objective of the upcoming clinical trial is the demonstrate anti-inflammatory efficacy similar to that of other steroid-based treatments with less frequent (twice-daily) dosing, while maintaining the safety profile of current loteprednol etabonate products.

According to Kim Brazzell, PhD, Kala’s chief medical officer, in preclinical studies, LE-MPP demonstrated a superior pharmacokinetics profile in target tissues compared to currently marketed loteprednol etabonate products. In head-to-head preclinical studies, LE-MPP delivered significantly greater levels of drug to the aqueous humor-as well as the cornea, conjunctiva, and retina-than either Lotemax Suspension or Lotemax Gel with similar dosing regimens.

“If (the upcoming clinical trial is) successful, this would represent a significant dosing advantage compared to other topical steroids, which are currently indicated for four times a day dosing,” Dr. Brazzell said.

“The global topical corticosteroid market is significant and growing based on the aging population,” said Guillaume Pfefer, Ph.D., president and chief executive officer of Kala. “A topical corticosteroid with superior penetration, pharmacokinetics, and a more favorable dosing regimen would be a welcome alternative to current treatment regimens.”

“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, Durham, NC. “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.”

Beyond the post-surgical program, Dr. Pfefer said Kala plans to initiate clinical programs with lower doses of LE-MPP in both dry eye disease and blepharitis in 2014.

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