Sun Pharmaceutical Industries announced the U.S. launch of Cequa, a topical ophthalmic treatment indicated to increase tear production in patients with keratoconjunctivitis sicca.
Cequa (cyclosporine ophthalmic solution 0.09%), a calcineurin inhibitor immunosuppressant, is delivered with nanomicellar technology to improve the bioavailability and physicochemical stability of cyclosporine to improve ocular tissue penetration, the company said in a press release.
Recent results from a multicenter, randomized, double-masked, vehicle-controlled phase 3 confirmatory study involving 744 subjects showed that the patients who were randomized to Cequa for 12 weeks had a statistically significant improvement in the primary endpoint compared to those who were treated with vehicle. The results indicated that 16.6% of the subjects who used Cequa experienced an increase of at least 10 mm in Schirmer’s score from baseline as compared to 9.2% (p < .01) of those who used vehicle, according to the release.
The company stated that Cequa was also found to be associated with statistically significant improvements in the key secondary endpoints, with improvements in both corneal and conjunctival staining compared to vehicle. Sixty-five percent of eyes had a completely clear central cornea after 12 weeks of treatment vs. 56.9% of those who received vehicle (p = .0022).
The most commonly reported ocular adverse event was instillation site pain, at 24.2% in the Cequa group and 4.3% in the vehicle group, Sun said in the release.
Cequa is dosed twice daily and will be available in a single-use vial, the company said.
Sun Pharma also introduced Cequa Support Specialty Pharmacy, a program designed to enable commercially insured patients to easily obtain Cequa. Cequa Support can provide insurance plan benefits verification, prior authorization support and appeals assistance. The program also provides free home delivery.