Leading specialty generic pharmaceutical company Sun Pharmaceutical Industries Ltd has reportedly announced the launch of CEQUA (cyclosporine ophthalmic solution) 0.09% in the US by one of its subsidiaries.

The drug will evidently be used to increase tear production in keratoconjunctivitis sicca (dry eye) patients. Keratoconjunctivitis sicca (dry eye) is an inflammatory eye disease that is prevalent in over 16 million Americans.

Sources with knowledge of the matter reported that the drug contains the highest concentration of cyclosporine as approved by the U.S. FDA for ophthalmic use.

CEQUA is apparently the first and only cyclosporine treatment approved by the FDA that is delivered with nanomicellar (NCELL™) technology. The drug helps enhance the physicochemical stability and bioavailability cyclosporine, thus improving ocular tissue penetration.

The announcement seemingly follows the recent publication of findings from a randomized, double-masked, vehicle-controlled, multicenter Phase 3 analysis of CEQUA in which 744 dry-eye patients were treated either with CEQUA or by its vehicle.

Tracking 12 weeks of progress, CEQUA demonstrated statistically promising results in the primary endpoint compare to its vehicle, with majority of patients observing at least a 10 mm increase in Schirmer’s score from baseline.

Evidently, the drug also showed statistically favorable results in the key secondary endpoints, with improvements in both conjunctival and corneal and staining as opposed to its vehicle. Noticeable improvement in total corneal staining was observed after one month following the treatment, with completely clear central cornea observed in 65% of the eyes at the end of 12 weeks.

Adverse events (AEs) reported during the trial were mostly mild in severity. Nearly 24.2 % of patients reported instillation site pain, of which 20.7 % of patients reported the pain to be mild, 3.0 % stated it as moderate and 0.5 % reported it to be severe.

Abhay Gandhi, CEO North America, Sun Pharma, stated that the launch of CEQUA in the U.S. will offer a truly innovative option for the treatment of patients with dry eye disease, an area with highly unmet medical needs.

With commercialization of CEQUA in the U.S., the company continues to establish itself as a global leader in developing innovative formulations of proven medications.

According to reliable sources, Sun Pharma will introduce CEQUA Support Specialty Pharmacy, which is intended to reduce out-of-pocket expenses and provide free home delivery.

Source Credits – https://www.businesswire.com/news/home/20191013005028/en/Sun-Pharma-Launches-CEQUA-Treatment-Dry-Eye