Improvement In Total Corneal Staining And Visual Acuity With Cyclosporine Ophthalmic Solution 0.09% In A Phase 4 Study Of Patients With Dry Eye Disease Inadequately Controlled By Cyclosporine Ophthalmic Emulsion 0.05%
Published 2024 - 42nd Congress of the ESCRS
Reference: FP07.04 | Type: Free paper | DOI: 10.82333/ntx2-fy50
Authors: Josh Johnston 1 , Richard Adler 2 , Michelle Hessen* 3 , Kelly Nichols 4 , Francisco Figueiredo 5 , Maurizio Rolando 6 , Kim Truett 7 , Maitee Urbieta 8 , Brittany Mitchell 8
1Georgia Eye Partners,Atlanta, GA,United States, 2Belcara Health,Baltimore, MD,United States, 3Wilmer Eye Institute,Johns Hopkins University,Baltimore, MD,United States, 4School of Optometry,University of Alabama at Birmingham,Birmingham, AL,United States, 5Department of Ophthalmology & Bioscience Institute, Faculty of Medical Sciences,Newcastle University,Newcastle upon Tyne,United Kingdom, 6Ocular Surface Center,ISPRE Ophthalmic SRL,Genoa,Italy, 7KCT Data, Inc.,Alpharetta, GA,United States, 8Sun Pharmaceutical Industries, Inc.,Princeton, NJ,United States
Purpose
Dry eye disease (DED) is a multifactorial disorder characterized by loss of tear film homeostasis leading to ocular surface inflammation and damage. In DED, visual impairment is related to corneal epithelial damage, so improved corneal fluorescein staining (CFS) may be associated with improved vision. Cyclosporine ophthalmic solution 0.09% (CsA 0.09%) and cyclosporine ophthalmic emulsion 0.05% (CsA 0.05%) are topical immunomodulatory agents indicated to increase tear production in DED. The nanomicellar formulation of CsA 0.09% may improve ocular surface drug delivery. We assessed the effect of CsA 0.09% on CFS and best-corrected visual acuity (BCVA) in patients with DED inadequately controlled on CsA 0.05%.
Setting
This was a multicenter study conducted at 10 sites in the United States.
Methods
This Phase 4, open-label study enrolled adults with DED inadequately controlled on CsA 0.05% for ≥3 months. Patients received 1 drop CsA 0.09% per eye twice daily for 12 weeks. CFS and BCVA were assessed at baseline; Weeks 4, 8, and 12; and/or early discontinuation. CFS was assessed in 5 corneal areas 2–2.5 minutes after instilling 1 drop 0.5% fluorescein per eye and scored on a 0–4 modified NEI scale in 0.5-point increments (0, no stain; 4, severe stain). Total CFS score summed all area scores. BCVA was assessed using the Snellen eye chart and then converted to logMAR for improved linearity. Patients must have correctly read ≥50% of the letters per line to accept that line. Safety assessments included adverse event (AE) monitoring.
Results
The intent-to-treat population included 124 patients. The mean (standard deviation [SD]) age was 65.6 (11.54) years. The mean (SD) baseline total CFS score for both eyes (OU) was 5.7 (3.37), and the mean (SD) change from baseline was −3.1 (2.88) at Week 12 (P <0.0001). The mean (SD) baseline BCVA OU was 0.05 (0.12) logMAR, and the mean (SD) change from baseline at Week 12 was −0.02 (0.079) logMAR (P = 0.0038). Both the right and left eyes had statistically significant reductions from baseline in total CFS score at Week 12 regardless of relative BCVA (P <0.0001 for each). In total, 58 patients (43.3%) reported ≥1 AE; most (73.8%) AEs were mild. Instillation site irritation was most common, reported by 12.7% of all patients.
Conclusions
Twice-daily CsA 0.09% was associated with significant improvements in both total CFS score and BCVA OU at Week 12 of treatment. Additionally, significant reductions in total CFS score in both the right and left eyes were noted at Week 12 regardless of relative BCVA. CsA 0.09% was generally well tolerated throughout the study. These data support the efficacy and safety of CsA 0.09% in improving DED signs and symptoms in patients with an inadequate treatment response to CsA 0.05%.