New Dry Eye Therapy Gains Formulary Coverage

OptumRx is the latest major commercial plan to add the corticosteroid loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis, Kala Pharmaceuticals) to its formulary, effective May 21, 2021. More than 88 million people with commercial health insurance now have access to the therapy, Todd Bazemore, chief operating officer of Kala, said in a company news release.

“We anticipate this figure will continue to grow from our ongoing efforts with commercial and Medicare Part D health plans, as we work toward our goal of delivering broad payer coverage for Eysuvis to the millions of people in the United States who suffer from dry eye disease,” he said in the statement.

Previously, Kala announced that Cigna had added Eysuvis as the preferred brand on its commercial formulary, effective May 15, 2021, and Express Scripts added the therapy to its formulary effective February 5, 2021.

The FDA approved Eysuvis in October 2020 for the short-term treatment of dry eye disease based on the results of three phase 3 trials and one phase 2 trial. Statistical significance was seen in two of the phase 3 trials with the endpoint of ocular discomfort in both the intent-to-treat population and a subgroup of patients with severe ocular symptoms.

The most common adverse event seen was site pain, which was reported in 5% of patients. The therapy uses Kala’s AMPPLIFY MPP drug delivery technology to enhance penetration of loteprednol etabonate in the eye. The therapy is contraindicated in viral diseases of the cornea, including epithelial herpes simplex keratitis, vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases.

Eysuvis became available in January 2021. Between early January and April 23, 2021, more than 11,600 prescriptions were filled for Eysuvis.

About 6.8% of the population, or about 16.4 million people, is estimated to have dry eye disease. Prevalence is higher among women than men and increases with age.