- Presentation at the American Academy of Optometry (AAOPT) 2023 showed significant improvements with CEQUA®for topical ophthalmic use in both corneal fluorescein staining (CFS) and symptom questionnaire scores starting at 4 weeks and continuing to 12 weeks
- Study design mirrors real-world experience with dry eye disease, including allowing use of artificial tears and measurement of CFS in all five corneal zones
Mumbai, India & Princeton, NJ, October 12, 2023 – Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced the presentation of Phase 4 data showing that CEQUA® (cyclosporine ophthalmic solution) 0.09% 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 keratoconjunctivitis 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% 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 the first and only U.S. 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 characterization 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%) 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%) reported at least one treatment-emergent adverse event (AE); most AEs were mild in severity (73.8%). The most common treatment-related AEs were instillation site irritation and instillation site pain; all other treatment-related AEs occurred in fewer than 2% of patients.
In addition to the rapid and sustained symptomatic improvement in patients with dry eye disease treated with CEQUA, this study is notable for its design, which allows for use of artificial tears, thus replicating real-world conditions as closely as possible for a controlled clinical trial,” noted Brittany Mitchell, OD, Head of Medical Affairs, Ophthalmics, at Sun Pharma. “The data presented at the American Academy of Optometry meeting represent the first of a series of assessments from this trial, with results thus far consistent with the efficacy, safety, and convenient dosing of CEQUA. We look forward to sharing additional information as we continue to analyze the data from this trial.”
Original website link: https://sunpharma.com/wp-content/uploads/2023/10/Press-Release-CEQUA-showed-sustained-improvement-in-dry-eye-disease-patients-switched-from-Restasis.pdf