Ciclosporin A 0.1% emulsion effective in patients with severe dry eye disease: Study

A new study published in the Graefe's Archive for Clinical and Experimental Ophthalmology found that ciclosporin A (CsA) 0.1% cationic emulsion may be safe, efficient, and well-tolerated when used in clinical settings to treat severe dry eye disease. It can be difficult to identify and treat dry eye disease (DED), often referred to as keratoconjunctivitis sicca, in clinical practice. DED is a chronic, multifactorial, and complicated ocular disorder that requires long-term care. The effectiveness, safety, and tolerability of ciclosporin A (CsA) 0.1% cationic emulsion (CE) in regular clinical practice as a remedy for adults with severe keratitis and dry eye disease that continued inadequately controlled with artificial tears were assessed in the PERSPECTIVE study. Thus, Ines Lanzl and colleagues analyzed the data from German ophthalmology clinics to offer additional detailed information on CsA 0.1% CE.

Adults beginning CsA 0.1% CE (one drop in each eye before bed) were the subjects of the study, and they were monitored at Weeks 4, 12, and 24 as well as Month 12. Mean shift from baseline in corneal fluorescein staining (CFS) score (Oxford Grade Scale) at Month 12 was the main outcome. Secondary endpoints looked at adverse events (AEs) and the intensity of ocular signs and symptoms.

A total of 236 patients from 20 German ophthalmology clinics took part in the PERSPECTIVE research. After receiving CsA 0.1% CE, CFS scores of patients significantly decreased starting in Week 4 and continued to do so until Month 12 (P<0.0001). By Month 12, 81.6% of patients had improved their CFS score from baseline.

Significant improvements in the intensity of subjective ocular symptoms (all P ≤ 0.015) and eyelid and conjunctival erythema at month 12 were seen with CsA 0.1% CE (P < 0.001) when compared to baseline. The safety statistics aligned with the established safety profile of 0.1% CE CsA. 95.7% of patients and 97.2% of doctors assessed tolerability as "satisfactory," "good," or "very good."

Overall, a country-level sub-analysis of the PERSPECTIVE study data from German ophthalmology clinics revealed results that are comparable to those reported for the entire study population which are indicative of the treatment outcomes that ophthalmologists may look forward with CsA 0.1% CE treatment in real-life clinical practice. Beginning with Week 4 and continuing through Month 12, CsA 0.1% CE significantly decreased the severity of keratitis and DED signs and symptoms.

Source:

Lanzl, I., Deuter, C. M. E., Lorenz, K., & Geerling, G. (2024). Real-world insights and outcomes related to ciclosporin A 0.1% cationic emulsion for the long-term treatment of dry eye disease in Germany: Country-level sub-analysis of the PERSPECTIVE study. In Graefe’s Archive for Clinical and Experimental Ophthalmology (Vol. 262, Issue 10, pp. 3261–3271). Springer Science and Business Media LLC. https://doi.org/10.1007/s00417-024-06414-z