Kala Gets the Greenlight from FDA for Dry Eye Disease Treatment

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Kala Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. 

Roughly 16.4 million U.S. adults have been diagnosed with dry eye disease, a chronic, episodic, multifactorial disease. It's more than just the bothersome symptoms of scratchy and itchy feeling, blurriness, burning, eye fatigue and light sensitivity. It also increases your risk for inflamed cornea, cornea eye disease, corneal ulcers and injuries, and eye infections. 

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Over-the-counter treatments fail due to the body’s natural protective system. The body is surrounded by boundary tissues to prevent foreign matter from penetrating. Mucus coats these tissues as a protective barrier, but also limits treatments from penetrating, thereby reducing their effect.  

“The challenge is: can you get through mucus? This is true in any disease where mucus can prevent you from getting to the right target. The lung, the intestine, the vagina, the eye—all of these have significant mucosal barriers. There are a variety of companies that do what I’d call ‘bioadhesive’—they stick to mucus. But Kala is the first company I’ve seen that’s actually developed a way to get through mucus to penetrate the mucosal barrier,” said Robert Langer, ScD Kala co-founder and Koch Institute Professor at Massachusetts Institute of Technology. 

Kala’s proprietary AMPPLIFY drug delivery technology is what gets EYSUVIS its backstage pass to penetrate the mucus barrier and delivering the loteprednol etabonate (LE) to the ocular tissue. The corticosteroid then works to relieve swelling, redness and itching by targeting the immune response that drives dry eye disease flares.  

“The approval of EYSUVIS ushers in a new era in the treatment of dry eye disease and offers promise to the millions of dry eye patients who experience acute exacerbations, or flares, of their disease each year,” said Edward Holland, M.D., Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. “For the first time we will be able to offer dry eye patients a therapeutic option that provides rapid relief for both the signs and symptoms of the disease and that is safe and well tolerated.” 

The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. The drug showed significant improvements in both the signs and symptoms of dry eye disease.  

“Dry eye disease can significantly decrease quality-of-life among affected patients and drive decreased workplace productivity, contact lens intolerance and discontinuation, and poor cataract and refractory surgery outcomes,” said Kelly Nichols, O.D., M.P.H., Ph.D., F.A.A.O., Dean of the University of Alabama at Birmingham School of Optometry. “As the prevalence of dry eye disease increases, there is a tremendous need for new therapies to manage mild-to-moderate dry eye disease patients, many of whom currently go untreated. I am excited by the approval of EYSUVIS and confident that having access to an approved corticosteroid specifically for dry eye disease will meaningfully impact the management of patients across the U.S.” 

Kala had their first FDA approval in 2018 with their corticosteroid for treatment of post-operative ocular inflammation and pain, INVELTYS. INVELTYS launched in the U.S. in January 2019 and is similar to EYSUVIS except at a higher 1% concentration of LE for post-surgery, versus .25% for dry eye disease treatment. INVELTYS runs around $266 for a 2.8 mL bottle, but offers co-pay cards to bring the cost down to as little as $40 for eligible patients.  

Kala plans to launch EYSUVIS in the US by the end of the year.

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