FIRST: Sun Pharma unveils dry-eye treatment drug CEQUA in US

New Delhi: Through a release, drug major, Sun Pharmaceutical Industries Ltd. (Sun Pharma) today announced that one of its wholly-owned subsidiaries has commercialized CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S indicated for the treatment of dry eye disease.

CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use approved by the U.S. Food and Drug Administration (FDA), is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease that afflicts more than 16 million people in the U.S.

CEQUA is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar (NCELL) technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration.

Commenting on the same, Abhay Gandhi, CEO North America, Sun Pharma said, "The U.S. launch of CEQUA, the third product in our growing ophthalmic portfolio, marks the availability of a truly innovative treatment option for patients with dry eye disease – an area with a high unmet medical need," said

"As a higher concentration cyclosporine product than what is currently commercially available, delivered with NCELL technology, CEQUA continues to demonstrate our leadership in creating novel formulations of proven medications, " Gandhi added.

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This announcement follows the recent publication of results from a multicenter, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study in which 744 patients with dry eye were treated either with CEQUA or its vehicle. After 12 weeks of treatment, as compared to vehicle, CEQUA showed a statistically significant improvement in the primary endpoint, the percentage of patients with an increase of at least 10 mm in Schirmer's score (a measurement of tear production) from baseline (16.6% vs. 9.2%; p<0.01).

"CEQUA is an important addition to the treatment armamentarium for keratoconjunctivitis sicca, a complex condition that is not conducive to a one-dimensional therapeutic approach," commented Joseph Tauber, M.D., founder, Tauber Eye Center in Kansas City, MO. "The availability of CEQUA will enable eye care professionals to further tailor dry eye treatment to individual patients' needs."

Paul Karpecki, O.D., FAAO, director of cornea services at the Kentucky Eye Institute in Lexington, KY, added, "Keratoconjunctivitis sicca causes symptoms of burning, stinging, itching, grittiness, and dryness, underscoring the need for tolerable drug therapy with a fast onset of action. The CEQUA clinical study results strengthen the rationale for using this product as a means to penetrate the tear film and improve drug delivery of cyclosporine into the eye."

Sun Pharma is also introducing CEQUA SUPPORT Specialty Pharmacy, a program designed to enable commercially insured patients to easily obtain CEQUA. Once a patient's prescription is submitted, CEQUA SUPPORT will provide several important services including insurance plan benefits verification, prior authorization support, and appeals assistance. This program is structured to minimize out-of-pocket cost and provides free home delivery.

CEQUA (cyclosporine ophthalmic solution) 0.09% is a patented, novel, proprietary nanomicellar (NCELL) formulation of cyclosporine in a clear, preservative-free, aqueous solution. CEQUA provides the highest FDA-approved concentration of cyclosporine for ophthalmic use and is the first and only approved cyclosporine treatment delivered with NCELL technology. The innovative NCELL formulation penetrates the aqueous layer of the tear film in the eye, then the nanomicelles break up
to release cyclosporine to penetrate ocular tissues.