New Phase 4 data highlight Cequa’s role in treating dry eye disease

Cequa (cyclosporine 0.09%) significantly improves the signs and symptoms of dry eye disease (DED) in patients who had inadequate response to Restasis, offering a potentially more effective alternative for managing DED, according to results from a Phase 4 study presented at the European Society of Cataract and Refractive Surgeons (ESCRS) 2024 meeting..

The single-arm, open-label study enrolled 134 adult patients with a history of DED poorly managed on Restasis. After switching to Cequa, patients showed notable improvements in corneal fluorescein staining (CFS) and best-corrected visual acuity (BCVA) from Week 4 to Week 12. At Week 12, the data indicated significant enhancement in both CFS and BCVA.

Cequa, the only FDA-approved cyclosporine treatment using nanomicellar NCELL technology, aims to enhance drug delivery and ocular penetration. Adverse events were mostly mild, with less than 2% of patients experiencing serious side effects. Investigator Dr. Michelle Hessen highlighted the promising results, noting significant improvements in key clinical markers for DED patients.

Reference
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.