Kala Pharmaceuticals announced that it received FDA approval for its Eysuvis treatment for signs and symptoms of dry eye disease.
Watertown, Mass.-based Kala’s Eysuvis loteprednol etabonate ophthalmic suspension uses the company’s Ampplify mucus-penetrating particle (MPP) drug delivery technology to enhance the penetration of loteprednol etabonate (LE) into target tissue on the ocular surface, according to a news release.
Four clinical trials demonstrated significant improvements in both the signs and symptoms of dry eye disease, as Eysuvis was well-tolerated across all trials and statistical significance in symptom endpoints of ocular discomfort severity was observed in two of the three Phase 3 trials conducted.
The company said that, prior to Eysuvis, there were no FDA-approved ocular corticosteroids for treating dry eye disease, and it plans to launch the platform in the U.S. by the end of 2020.
“The FDA approval of Eysuvis as the first prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease is a major accomplishment for Kala and an important moment for patients, who have been waiting for an FDA-approved, safe, effective and fast-acting therapy,” Kala chairman, president & CEO Mark Iwicki said in the release. “As we prepare to launch Eysuvis, we will leverage our strong foundation of highly experienced ophthalmology marketing, sales and market access professionals with the goal of establishing Eysuvis as the preferred, first-line prescription therapy for dry eye disease. We’d like to thank the many patients and investigators that were involved in the clinical trials that led to this important milestone.”