Topical Cyclosporine Drops Improve Corneal Damage in Vernal Keratoconjunctivitis

Clinicians may use cyclosporine A cationic ophthalmic emulsion (CsA CE) as an alternative to corticosteroids for patients with vernal keratoconjunctivitis (VKC), according to research published in Eye. Use of the topical agent lowers corneal fluorescein staining (CFS) scores and produces adverse events that are mostly mild to moderate, according to the report. 

“Although topical corticosteroids are acknowledged as effective anti-inflammatory agents in active ocular allergy, a key limitation of their use in severe VKC is the risk of glaucoma and/or cataract development with long-term use,” according to the study authors. “The utility of topical CsA for the treatment of VKC has been advanced by the development of cyclosporine A cationic ophthalmic emulsion (CsA CE) 0.1% (1 mg/mL). This cationic oil-in-water emulsion for topical ocular use remains on the ocular surface longer than conventional anionic CsA formulations, thereby optimizing its bioavailability and therapeutic effects.”

Researchers performed a pooled assessment of the NOVATIVE (ClinicalTrials.gov Identifier: NCT00328653) and VEKTIS (ClinicalTrials.gov Identifier: NCT01751126) studies — both clinical trials examined the efficacy of treating VKC with CsA CE. The team included individuals with VKC who were randomized to treatment with a high (0.1% concentration; n=96) or low dose (0.05% concentration; n=93) of CsA CE and participants treated with a vehicle control (n=98) for a 28-day study duration. Both studies evaluated multiple efficacy endpoints, but investigators only included corneal fluorescein staining (CFS) in the pooled analysis. 

Overall, CFS improved in all treatment groups, evidenced by score reductions of 1.6, 1.7, and 1.0 from baseline for the high-dose, low-dose, and vehicle treatment groups, respectively. These scores attained statistical significance in the high- and low-dose treatment groups when compared with the vehicle treatment groups (P =.0124 and P =.0015, respectively). Adverse events were mostly mild to moderate and reported in 37.5%, 34.4%, and 37.8% of participants in the high-dose, low-dose, and vehicle treatment groups, respectively. 

“No clinically significant changes in visual acuity, [intraocular pressure], or slit lamp examination findings were reported with long-term use of CsA CE,” according to the researchers. “In addition, systemic absorption of CsA was negligible and below the upper limit of quantification (5 ng/mL). These results support the use of CsA CE as a safe alternative to topical corticosteroids for the treatment of VKC.”

Different inclusion criteria for both of the studies used in the pooled analysis is an acknowledged limitation to the research.