Sun Pharma announces positive Phase 4 data results in dry eye disease

(Image credit: Adobe Stock/Vladimir)

Sun Pharmaceutical presented Phase 4 data at ESCRS 2024 showing that cyclosporine ophthalmic solution 0.09% significantly improves dry eye disease symptoms and corneal staining in patients inadequately controlled on Restasis, with positive results observed through 12 weeks of treatment.

Sun Pharmaceutical Industries Ltd. presented Phase 4 data further demonstrating that cyclosporine ophthalmic solution (Cequa) 0.09% induces sustained improvement in the signs and symptoms of dry eye disease (DED) in patients previously prescribed cyclosporine ophthalmic emulsion (Restasis) 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 cyclosporine ophthalmic solution 0.09%.

This Phase 4, multicenter, open-label, single-arm study of DED patients not adequately controlled after treatment with Restasis and switched to cyclosporine ophthalmic solution 0.09% 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 cyclosporine ophthalmic solution 0.09% showed significant improvement in BCVA at Week 8 and Week 12.

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 BCVA scores at baseline and at 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.

Cequa is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar NCELL technology. NCELL technology is believed to improve the bioavailability of cyclosporine and enhance 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 the Wilmer Eye Institute in Baltimore, Maryland. “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.”