Kala Pharmaceuticals has submitted an IND application to the FDA to initiate a Phase III program with its Mucus Penetrating Particle (MPP)-formulated loteprednol etabonate ophthalmic nano-suspension product (LE-MPP) for the treatment of post-operative inflammation and pain following cataract surgery.

Kala’s proprietary 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. Kala’s MPPs are designed to potentiate pharmacological effects within target tissues. The objective of the upcoming clinical trial with Kala’s LE-MPP product is to 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.

The objective of the Phase III trial will be to demonstrate if twice-daily administration of 1% LE-MPP is effective in the treatment of inflammation and pain following cataract surgery. If successful, it would represent a dosing advantage compared to other topical steroids, which are currently indicated for four times a day dosing.

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