Kala Pharmaceuticals (NSDQ:KALA) said today that it submitted a new drug application to the FDA for its KPI-121 0.25% topical product designed for patients with dry eye disease.
The Waltham, Mass.-based company noted that roughly 33 million people in the U.S. have dry eye disease and nearly 90% of those patients experience flares in symptoms. Kala is positioning its drug as a tool to help manage dry eye flares and other conditions associated with dry eye disease.
The drug makes use of Kala’s Ampplify mucus-penetrating particle technology. The company makes selectively-sized nanoparticles with coatings that are designed to boost drug penetration and distribution in eye tissues.
Kala’s NDA filing was supported by three clinical trials, which included roughly 2,000 patients with dry eye disease.
“We are pleased to submit the NDA for KPI-121 0.25% to the FDA,” Kala’s CMO Kim Brazzell said in prepared remarks. “We believe the data from Stride 1, Stride 2 and the Phase 2 trials demonstrate a robust data package supporting the clinically meaningful efficacy, safety and tolerability of KPI-121 0.25%. Today, there are limited treatment options for dry eye disease and KPI-121 0.25% has the opportunity to address significant unmet needs for patients and health care professionals.”
Earlier this month, Kala priced an underwritten public offering of 7,500,000 shares of common stock at $8.25 per share.
KALA shares were trading at $8.96 apiece yesterday when the markets closed, up 4.7%.
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