Sun Pharmaceutical Industries Ltd said one of its wholly-owned subsidiaries has commercialized CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S.
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.
It is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar technology, which, according to the company, helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration.
The 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, the company said.
CEQUA is dosed twice daily and will be available as a single-use vial.
“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 Abhay Gandhi, CEO North America, Sun Pharma, adding that the launch proved the company’s ability to continue to create novel formulations of proven medications.
The company recently published 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, 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).
Additionally, CEQUA was associated with statistically significant improvements in the key secondary endpoints, with improvements in both corneal and conjunctival staining, compared to vehicle.
It also showed improvement in total corneal staining as early as one month following treatment, with 65% of eyes having completely clear central cornea after 12 weeks (vs 56.9% for vehicle; p=0.0022), Sun Ophthalmic said.
“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, in a company-supplied statement.
“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, pointed out that Keratoconjunctivitis sicca causes symptoms of burning, stinging, itching, grittiness, and dryness. There was, he said, a 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 has also introduced a support program 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,” the company said.
Dry eye is a chronic disease affecting millions of patients around the world, with a significant population, greater than 16 million patients, present in the United States.
It occurs when the quantity and/or quality of tears fails to keep the surface of the eye properly lubricated. The disease causes a scratchy sensation or a feeling that something is in the eye.
Sun Ophthalmics is the branded ophthalmic division of one of Sun Pharma’s wholly owned subsidiary.
India-based Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company and has customers and patients in over 100 countries across the world.