What’s cyclosporine ophthalmic emulsion 0.05%?
Cyclosporine A (CsA) is a calcineurin inhibitor that interferes with T-cell function and was initially used clinically as a systemic immunosuppressive agent to prevent rejection after organ transplantation. The use of topical CsA to treat ocular inflammation, including dry eye, was first investigated in the 1980’s and ultimately led to several large clinical trials. The end result was FDA approval of Restasis® (cyclosporine ophthalmic solution) 0.05% in 2003.
So what’s the problem?
Despite data that demonstrates increases in Schirmer wetting and improved tear function with CsA of varying concentrations (including Restasis®), studies of health claims data reveal that on average, patients only filled 4.44 months of medication over a 12-month period, and 18% of all dry eye patients filled only a 1-month supply.1
A majority of patients using Restasis®and Xiidra® (lifitegrast ophthalmic solution) 5% discontinued treatment within one year.2
Are there any alternative therapies if patients aren’t satisfied with Restasis®?
Patients may be living with and treating DED indefinitely, so tolerable management is vital.3 CEQUA® (cyclosporine ophthalmic solution) 0.09% utilizes a novel, nanomicellar vehicle to deliver CsA to ocular tissues. A real-world longitudinal cohort study showed that after nearly a year (360 days), more patients were still using CEQUA® than Restasis® and Xiidra®:4
Median treatment duration:
- CEQUA®: 11.6 months
- Xiidra®: 8.8 months
- Restasis®: 7.9 months
Study design: Real-world, retrospective, longitudinal cohort study utilizing data from the Symphony Health Integrated Dataverse (IDV), a national provider-based claims database, examining time to treatment discontinuation, probability of treatment discontinuation, and treatment persistence among patients with DED treated with CEQUA (n=1846), Restasis (n=2248), or Xiidra (n=3008).4
Can you give me some details about CEQUA® efficacy data?
Yes! CEQUA® delivers improved total corneal staining after just 14 days.5
- 65% of central corneas were completely clear6 at 12 weeks: (vs. 56.9% for vehicle; P=0.02) At baseline, 38.3% of patients taking CEQUA® had complete clearing (vs. 37.5% with vehicle).
- Improved tear production: More CEQUA® patients experienced a clinically meaningful improvement of nearly double the tear production (≥ 10 mm change from baseline in Schirmer test score) compared to vehicle at 3 months.6
What about safety data?
The most common adverse events reported in CEQUA® patients were instillation site pain (22%) and conjunctival hyperemia (6%).6 Most ocular adverse events reported by patients treated with CEQUA® were mild or moderate.
Wasn’t Phase 4 clinical data recently released?
Yes! Recently released, was exciting data from a Phase 4 study of patients whose DED and symptoms were inadequately controlled on Restasis® and who were switched to CEQUA®.7
- Significant improvements in total central corneal staining were seen as fast as week 4 and continued to week 12.7
- Artificial tears use reduced from 3 times to 1 time per day after switching from Restasis® to CEQUA® for 12 weeks.8
- 69% of patients preferred CEQUA®8 over Restasis® (22%) by the end of the study.
- Adverse effects were consistent with the safety profile seen in the pivotal trials, and no new safety signals were observed.8
CEQUA is a registered trademark of Sun Pharmaceutical Industries Limited.
PM-US-CQA-1389