[Topical cyclosporine A and risk of ocular surface neoplasia]

Cyclosporine A (CsA) has well-known cutaneous carcinogenic effects when administered systemically. In ophthalmology, it is increasingly used in the form of eye drops since its indication for moderate to severe eye dry eye. The goal of this review of the literature is to evaluate a possible link between topical ocular CsA use and the occurrence of ocular surface neoplasia.

A literature review was performed. Publications evaluating the safety and efficacy of topical CsA as well as studies on the epidemiology and risk factors for conjunctival neoplasia and cases of conjunctival neoplasia were analyzed. Finally, post-market surveillance data from commercially available CsA eye drops were also evaluated.

Five cases of conjunctival neoplasia in patients treated with systemic and/or topical CsA have been described in the literature, three with systemic administration alone, another with combined systemic and local administration, and one case of local administration alone. In these cases, no direct link with the administration of ocular topical CsA could be determined. Among the numerous prospective studies evaluating the safety and efficacy of topical CsA as well as the case-control studies evaluating the risk factors for developing conjunctival neoplasia, no relationship between the occurrence of conjunctival neoplasia and the use of topical ocular CsA was observed.

Despite plausible pathophysiologic mechanisms, to date there is no evidence of an increased risk of ocular surface neoplasia with the use of topical ocular CsA. Further studies specifically addressing this question and with a longer duration are needed in order to precisely evaluate this theoretical risk.