Sun Pharmaceutical presented new phase 4 clinical data highlighting the efficacy of Cequa (cyclosporine ophthalmic solution) 0.09%. The data demonstrated that Cequa provides sustained improvements in the signs and symptoms of dry eye disease (DED) in patients who were previously inadequately managed on Restasis (cyclosporine ophthalmic emulsion) 0.05%.

The study results indicate significant improvements in both corneal health and visual acuity for patients switched from Restasis to Cequa. Notably, patients experienced substantial reductions in total corneal fluorescein staining (CFS) and enhanced best corrected visual acuity (BCVA) within 12 weeks of treatment with Cequa, according to Sun. 

The multicenter, open-label, single-arm study enrolled 134 adults diagnosed with DED who had not achieved sufficient relief with Restasis after at least 3 months of use. Key metrics assessed included CFS and BCVA at baseline, followed by evaluations at Weeks 4, 8, and 12.

  • Corneal Health: The study demonstrated a significant reduction in CFS scores, starting as early as Week 4 and continuing through Week 12
  • Visual Acuity: Patients treated with Cequa showed marked improvements in BCVA by Week 8, with further enhancements observed at Week 12
  • Patient Outcomes: By the end of the 12-week period, participants reported notable improvements across multiple parameters, including corneal staining and the modified symptom assessment in dry eye

Cequa utilizes Sun Pharma’s proprietary nanomicellar NCELL technology, which is designed to enhance the bioavailability and penetration of cyclosporine, making it the first and only FDA-approved cyclosporine therapy using this technology.

The study’s safety profile was consistent with known characteristics of cyclosporine treatments. While 84 patients (62.7%) reported at least one treatment-emergent adverse event (AE), the majority were mild in severity, with most commonly reported as instillation site discomfort. Serious AEs were rare, affecting less than 2% of participants, and only five patients discontinued due to AEs.

Discontinuation rates remained low overall, with only 19 of 134 participants (14.2%) dropping out for any reason over the 12-week period.