- Presentation at the European Society of Cataract and Refractive Surgeons (ESCRS) 2024 annual meeting showed significant improvements with CEQUA for topical ophthalmic use in total corneal staining and visual acuity within the 12-week study period
Sun Pharmaceutical Industries Limited, “Sun Pharma," presented phase 4 data further demonstrating that CEQUA (cyclosporine ophthalmic solution) 0.09% induces sustained improvement in the signs and symptoms of dry eye disease (DED) in patients previously prescribed Restasis (cyclosporine ophthalmic emulsion) 0.05% whose DED was inadequately controlled.
In the presentation at the European Society of Cataract and Refractive Surgeons (ESCRS) 2024 annual meeting in Barcelona, Spain, researchers reported that patients showed significant improvements in both total corneal staining and visual acuity after being treated with CEQUA.
This phase 4, multicenter, open-label single-arm study of DED patients not adequately controlled after treatment with Restasis and switched to CEQUA demonstrated significant improvements from baseline in both total corneal fluorescein staining (CFS) and best-corrected visual acuity (BCVA) at Week 12. CEQUA demonstrated significantly reduced total CFS scores from Week 4 through Week 12 of the study, and patients treated with CEQUA showed significant improvement in BCVA at Week 8 and Week 12.
CEQUA is the first and FDA-approved cyclosporine treatment delivered with nanomicellar NCELL technology. NCELL technology is believed to improve the bioavailability of cyclosporine and improved ocular penetration.
“It is extremely encouraging to see such positive results from treatment with CEQUA amongst Restasis patients who were inadequately controlled,” said investigator and presenter Michelle Hessen, OD, of Wilmer Eye Institute in Baltimore, MD. “Combined with previous results from the phase 4 study, we are pleased to report that at 12 weeks, study participants experienced significant improvements across several major signs and symptoms, including corneal fluorescein staining, modified Symptom Assessment in Dry Eye, and visual acuity.”
The phase 4 study enrolled 134 adults with a history and clinical diagnosis of DED who were inadequately controlled on Restasis therapy (based on severity of accepted signs and/ or symptoms of DED) for at least three months before screening/baseline.
Investigators assessed CFS and BVAC scores at baseline and Weeks 4, 8, and 12, and/or upon early discontinuation from the study.
Discontinuations were low; 19 of 134 patients discontinued for any reason. Throughout the study, 84 patients (62.7%) reported at least one treatment-emergent adverse event (AE), while the majority of AEs were mild in severity (73.8%) and most commonly related to installation site pain.
Serious AEs occurred in less than 2% of study patients, and only five patients discontinued the therapy and study because of AEs.
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About CEQUA
CEQUA (cyclosporine ophthalmic solution) 0.09% is a patented, novel, proprietary nanomicellar NCELL formulation of cyclosporine in a clear, preservative-free, aqueous solution. It 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.2
CEQUA is the first and only U.S. Food and Drug Administration (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.
References:
Johnston, J. Improvement in total corneal staining and visual acuity with cyclosporine ophthalmic solution 0.09% in a phase 4 study of patients
with dry eye disease inadequately controlled by cyclosporine ophthalmic emulsion 0.05%. Presented at 42nd Congress of the ESCRS 2024;
September 2024; Barcelona, Spain.New study focuses on scope of dry eye disease in the U.S. American Optometric Association; 2017. Available at:
https://www.aoa.org/news/clinical-eye-care/new-study-dry-eye-disease. Accessed September 10, 2019