Big Things Happening for Kala Pharmaceuticals

Kala is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS™ (loteprednol etabonate ophthalmic suspension) 0.25%, the first and only FDA approved short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery.

EYSUVIS™ is a nanoparticle suspension of loteprednol etabonate, a C-20 ester-based corticosteroid, with a proven anti-inflammatory effect and a demonstrated safety profile formulated using the novel and patented AMPPLIFY® Drug Delivery Technology. The keys to the AMPPLIFY® Drug Delivery Technology are nanoparticles of active drug specifically designed to have two proprietary attributes: (i) a particle size below 500 nm and (ii) a mucus-penetrating surface coating to facilitate the penetration of the mucus barrier. AMPPLIFY molecules have a surface coating that prevent mucus adhesion and clearance in the tear film. Avoiding clearance of the drug by mucus, allows drug particles to more successfully reach the target tissues, such as the cornea and conjunctiva in dry eye patients.

Mucins are long sticky macromolecules present on all mucosal surfaces, including the ocular surface. Secreted mucins present in the tear film play an important role as a barrier to particulate matter such as allergens, pathogens, and debris by trapping them via adhesive interactions and facilitating their removal from the ocular surface as the eyelid blinks. Drug particles in traditional suspensions are also susceptible to adhesive interactions with mucins. In contrast, drug particles formulated with AMPPLIFY® technology are engineered to avoid adhesion to mucins and can deliver enhanced drug distribution and penetration compared to traditional suspensions; thus, the therapeutic agent is spread more uniformly and achieves longer retention time on various mucosal surfaces.

In fact, a preclinical study showed that, one hour after dosing, loteprednol etabonate formulated with AMPPLIFY® Drug Delivery Technology sustained drug levels in the cornea 3.6 times higher than those from a traditional ophthalmic suspension.

Kala Pharmaceuticals also has a pipeline of preclinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. For more information on Kala, please visit www.kalarx.com.