Sun Pharmaceutical Industries announced the presentation of Phase 4 data showing that CEQUA (cyclosporine ophthalmic solution) 0.09 per cent induces sustained improvement in the signs and symptoms of dry eye disease (DED). CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with kerato conjunctivitis sicca (dry eye). In a presentation at the American Academy of Optometry (AAOPT) 2023 annual meeting in New Orleans, La., researchers reported that CEQUA elicited significant improvement in corneal fluorescein staining (CFS, a test used to detect damage to the cornea) and in modified Symptom Assessment in Dry Eye (mSANDE) scores in patients with DED whose disease was uncontrolled on Restasis (cyclosporine ophthalmic emulsion) 0.05 per cent therapy.1
In the 12-week Phase 4 multicenter study, twice-daily administration of CEQUA improved CFS and mSANDE scores starting at Week 4 of treatment and maintained these improvements through Week 12. CEQUA offers a high concentration of cyclosporine for ophthalmic use and is US Food and Drug Administration (FDA)-approved cyclosporine treatment delivered with nanomicellar NCELL technology, which helps to improve the bioavailability of cyclosporine, resulting in improved ocular tissue penetration.
“We were greatly encouraged to observe significant improvements in dry eye signs and symptoms as early as four weeks into treatment with CEQUA, and to see even greater improvements at eight weeks and again at 12 weeks,” said lead investigator Josh Johnston, OD, FAAO, of Georgia Eye Partners in Atlanta, Ga. “Moreover, by assessing corneal fluorescein staining in all five zones of the cornea, we were able to attain a more complete characterisation of corneal health than in many dry eye disease trials, which typically assess only a few corneal areas.”
The study enrolled adults with DED inadequately controlled (i.e., still symptomatic and/or exhibiting disease signs) on current Restasis therapy for at least three months, and who had a history and clinical diagnosis of DED for at least three months before screening/baseline. Patients received one drop of CEQUA in each eye twice daily for 12 weeks. Investigators assessed CFS and mSANDE scores at baseline and at Weeks 4, 8, and 12, and/or upon early discontinuation from the study. CFS was scored on a 0-4 grading scale in 0.5-point increments, with a score of 0 indicating no stain (i.e., healthy cornea) and a score of 4 reflecting a severe stain; investigators calculated a total CFS score by summing all five corneal area scores. The mSANDE questionnaire assessed frequency and severity of DED symptoms of dryness and irritation on a 0-100 scale, with 0 representing very low frequency/severity and 100 indicating very high frequency/severity.
Dr Johnston and colleagues presented results from 124 patients in the modified intent-to-treat (mITT) population. The mean (standard deviation [SD]) age of the patients was 65.5 (11.6) years; 110 of the patients (88 per cent) were female. The mean (SD) total CFS score was 5.7 (3.37) at baseline, and improved significantly (P <0.0001) to 4.0 (3.12) at Week 4, 2.9 (2.54) at Week 8, and 2.7 (2.36) at Week 12. Similarly, the mean (SD) mSANDE score was 67.1 (21.05) at baseline and improved significantly (P <0.0001) to 48.4 (23.31) at Week 4, 44.2 (24.28) at Week 8, and 38.3 (25.99) at Week 12.
CEQUA was generally well tolerated in the study, consistent with its established safety profile, and there were no new safety signals in the trial. Overall, 58 patients (43.3 per cent) reported at least one treatment-emergent adverse event (AE); most AEs were mild in severity (73.8 per cent). The most common treatment-related AEs were instillation site irritation and instillation site pain; all other treatment-related AEs occurred in fewer than 2 per cent of patients.