October 14, 2019

Sun Pharmaceuticals has announced the launch of Cequa™ (cyclosporine ophthalmic solution) 0.09%. The product, which received FDA approval in August 2018, is indicated to increase tear production in patients who have keratoconjunctivitis sicca (dry eye). It is the first and only FDA-approved cyclosporine treatment that uses nanomicellar (NCELL™) technology, which improves tissue penetration of the medication.

An estimated 16 million people in the U.S. have dry eye, a condition in which the body does not make enough tears or makes tears of poor quality. Good quality tears are necessary to properly lubricate and protect the eye’s surface. It is often chronic. Complications include an increased risk of eye infection, damage to the surface of the eye, and vision impairment. Dry eye can also lead to eye irritation or pain, or the feeling of something being caught in the eye.

In a confirmatory study, 16% of patients who received Cequa experienced an increase of at least 10mm in Schirmer’s score (a measurement of tear production) from baseline, compared to 9.2% of patients treated with the vehicle alone (a solution that did not contain the active pharmaceutical ingredient). Cequa also delivered statistically significant improvement in surface damage to the eye as measured using corneal and conjunctival staining. Staining is a procedure in which a dye is used to help assess ocular surface damage; only damaged areas of the eye’s surface will take up stain. Following 12 weeks of treatment with Cequa, 65% of patient’s eyes had a completely clear central cornea that did not take up stain compared to 56.9% of eyes treated with vehicle.

Recommended dosing is one drop in each eye twice daily, approximately 12 hours apart. Cequa can be used along with artificial tears, so long as the two products are used at least 15 minutes apart. Each Cequa vial is a single-use vial, and should be discarded immediately after the medication has been administered in both eyes.

The wholesale acquisition cost (WAC) for Cequa is $507 per month.

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