Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) today announced that 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.1 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.
"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. "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."
This announcement follows the recent publication of results from a multicenter, randomized, doublemasked, 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; improvement in total corneal staining was evident 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). Adverse events (AEs) reported in the trial were mostly mild in severity. The most commonly reported ocular AE was instillation site pain (24.2% in the CEQUA group, vs. 4.3% for vehicle); of the 24.2% of patients who reported instillation site pain in the CEQUA group, most of them reported the pain as being mild (20.7%), 3.0% reported it as moderate, and 0.5% reported it as severe.
"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.
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