Phase 4 data demonstrates Cequa’s sustained efficacy in dry eye disease

Cequa (cyclosporine ophthalmic solution; Sun Pharmaceutical) 0.09% provides sustained improvement in the signs and symptoms of dry eye disease (DED), according to Phase 4 data presented at the American Academy of Optometry 2023 annual meeting.

The study showed significant enhancements in corneal health and a reduction in dryness and irritation symptoms for patients whose DED was uncontrolled on previous therapy.

In a comprehensive 12-week multicenter study, Cequa demonstrated significant progress in both corneal fluorescein staining (CFS) and modified Symptom Assessment in Dry Eye (mSANDE) scores for patients whose DED had previously been unresponsive to Restasis (cyclosporine ophthalmic emulsion) 0.05% therapy.

The trial enrolled adults with inadequately controlled DED, despite a minimum of 3 months on Restasis therapy, and a documented DED history for at least 3 months prior to baseline. Patients were administered 1 drop of Cequa in each eye twice daily over the course of 12 weeks. Assessments were conducted at baseline, weeks 4, 8, and 12, or upon early discontinuation from the study.

Results from 124 patients in the modified intent-to-treat population were presented by Dr. Johnston and colleagues.

The mean total CFS score improved from 5.7 at baseline to 4.0 at week 4, 2.9 at week 8, and 2.7 at week 12. Likewise, the mean mSANDE score decreased from 67.1 at baseline to 48.4 at week 4, 44.2 at week 8, and 38.3 at week 12.

There was a consistent safety profile, with 43.3% of patients reporting at least 1 treatment-emergent adverse event, the majority of which were of mild severity (73.8%). There were no new safety concerns raised during the trial.

Instillation site irritation and instillation site pain were identified as the most common treatment-related adverse events, occurring in a minority of patients (fewer than 2%).

Read the full press release here.