Sun Pharma’s CEQUA shows sustained dry eye disease improvement in Phase 4 study

Sun Pharmaceutical Industries Limited has made a significant announcement regarding its groundbreaking product, CEQUA (cyclosporine ophthalmic solution) 0.09%. The company has unveiled Phase 4 data showcasing CEQUA’s exceptional ability to induce sustained improvement in the signs and symptoms of dry eye disease (DED). CEQUA is an immunosuppressant and calcineurin inhibitor designed to enhance tear production in patients afflicted with keratoconjunctivitis sicca, commonly known as dry eye.

The unveiling of these remarkable findings took place during a presentation at the American Academy of Optometry (AAOPT) 2023 annual meeting held in New Orleans, Louisiana. Researchers reported that CEQUA produced significant improvements in both corneal fluorescein staining (CFS), a test used to detect corneal damage, and in modified Symptom Assessment in Dry Eye (mSANDE) scores. Notably, these improvements were observed in patients with DED whose disease remained uncontrolled even after receiving Restasis (cyclosporine ophthalmic emulsion) 0.05% therapy.

In a comprehensive 12-week Phase 4 multicenter study, the administration of CEQUA twice daily led to the steady enhancement of CFS and mSANDE scores starting from the fourth week of treatment and maintaining these improvements until the twelfth week. CEQUA distinguishes itself by offering a high concentration of cyclosporine for ophthalmic use. It is also the first and sole cyclosporine treatment approved by the U.S. Food and Drug Administration (FDA) that incorporates nanomicellar NCELL technology. This technological innovation significantly improves the bioavailability of cyclosporine, resulting in enhanced penetration into ocular tissues.

Lead investigator Dr. Josh Johnston, OD, FAAO, of Georgia Eye Partners in Atlanta, Georgia, expressed their optimism, stating, “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. 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 experiencing inadequately controlled DED, meaning their symptoms persisted despite receiving Restasis® therapy for at least three months. These individuals also had a history and clinical diagnosis of DED for at least three months before baseline screening. Patients were instructed to apply one drop of CEQUA in each eye twice daily for a duration of 12 weeks. Throughout the study, investigators assessed CFS and mSANDE scores at various intervals, including baseline, Weeks 4, 8, and 12.

The results, derived from the modified intent-to-treat (mITT) population consisting of 124 patients, were highly promising. CFS scores significantly improved from a mean (standard deviation [SD]) of 5.7 (3.37) at baseline to 4.0 (3.12) at Week 4, 2.9 (2.54) at Week 8, and 2.7 (2.36) at Week 12. Similarly, mSANDE scores showed significant improvement from a mean (SD) of 67.1 (21.05) at baseline to 48.4 (23.31) at Week 4, 44.2 (24.28) at Week 8, and 38.3 (25.99) at Week 12.

Importantly, CEQUA demonstrated an excellent safety profile in the study, consistent with its established record. The trial did not reveal any new safety concerns, with 43.3% of patients reporting at least one treatment-emergent adverse event (AE), most of which were mild in severity (73.8%). The most frequently reported treatment-related AEs included instillation site irritation and instillation site pain, while all other treatment-related AEs occurred in fewer than 2% of patients.

Brittany Mitchell, OD, Head of Medical Affairs, Ophthalmics at Sun Pharma, emphasized the study’s significance, highlighting its real-world design that allowed the use of artificial tears. She noted that the data presented at the American Academy of Optometry meeting align with CEQUA’s efficacy, safety, and convenient dosing. Further data analysis from the trial is expected to provide additional insights into CEQUA’s effectiveness in addressing dry eye disease.

CEQUA (cyclosporine ophthalmic solution) 0.09% is a groundbreaking patented nanomicellar NCELL formulation of cyclosporine. It is presented as a clear, preservative-free aqueous solution, specially designed to boost tear production in individuals with keratoconjunctivitis sicca (dry eye). This inflammatory disease impacts more than 16 million individuals in the United States alone. CEQUA is dosed twice daily and is available in single-use vials. In a Phase 3 confirmatory study involving 744 patients with dry eye, CEQUA demonstrated significant improvements in tear production and ocular surface integrity when compared to a control group.