Sun Pharmaceuticals presented Phase 4 data further demonstrating that its novel, proprietary therapy, 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; AbbVie) 0.05% whose DED was inadequately controlled.

The Phase 4, multicenter, open-label single-arm study included 134 DED patients not adequately controlled after treatment with Restasis for at least 3 months before screening/baseline, and then switched to CEQUA. Results demonstrated significant improvements from baseline in both total corneal fluorescein staining (CFS) and 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.

According to a company press release, 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; only five patients discontinued the therapy and study because of AEs. The data was presented at the 2024 ESCRS meeting in Barcelona.

Sun Pharmaceuiticals says CEQUA is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar NCELL technology, which is believed to improve the bioavailability of cyclosporine and improved ocular penetration.