Cyclosporine ophthalmic emulsions for the treatment of dry eye: a review of the clinical evidence

Abstract

Dry eye has gained recognition as a public health problem given its high prevalence, morbidity and cost implications. Although dry eye is common and affects patients’ quality of life, only one medication, cyclosporine 0.05% emulsion, has been approved by the US FDA for its treatment. In this review, we summarize the basic science and clinical data regarding the use of cyclosporine in the treatment of dry eye. Randomized controlled trials showed that cyclosporine emulsion outperformed vehicles in the majority of trials, consistently decreasing corneal staining and increasing Schirmer scores. Symptom improvement was more variable, however, with ocular dryness shown to be the most consistently improved symptom over vehicle.

Efficacy of Trabodenoson in a Mouse Keratoconjunctivitis Sicca (KCS) Model for Dry-Eye Syndrome

“…D ry-eye disease (DED) or keratoconjunctivitis sicca is one of the most common ophthalmic conditions encountered in clinical practice, 1,2 and significantly lowers the quality of life of affected individuals. 2,3 Currently, two prescription drugs have been approved for the treatment of DED in the United States: 0.05% cyclosporine ophthalmic emulsion (formulated as Restasis 4 ) and 5% lifitegrast ophthalmic solution (formulated as Xiidra 5 ). However, both drugs are associated with a significant incidence of adverse effects affecting up to 25% of patients that include mostly instillation irritation, but also ocular pain, dysgeusia, and decreased visual acuity.…”

Effects of Lutein on Hyperosmoticity-Induced Upregulation of IL-6 in Cultured Corneal Epithelial Cells and Its Relevant Signal Pathways

“…Dry eye is a very common ocular disorder and characterized by deficiency of tear associated with inflammation and damage of ocular surface. There are numerous therapeutic procedures available for the treatment of dry eye, but all have their limitations [ 3 – 7 ]. The most common treatment for the dry eye is the use of topical tear substitutes.…”

“…Topical cyclosporine (an immunosuppressive and anti-inflammatory drug) alleviates the signs and symptoms of dry eye. However, some patients experience bothersome adverse effects (e.g., burning or irritation) and not all of the patients with dry eye show a consistent therapeutic response to this treatment [ 3 , 6 ]. Topical autologous serum also improves dry eye symptoms and signs.…”

Liquid Crystalline Nanoparticles as an Ophthalmic Delivery System for Tetrandrine: Development, Characterization, and In Vitro and In Vivo Evaluation

“…However, solutions contained in drops typically display poor corneal penetration and have short pre-ocular retention times. To overcome these shortcomings, emulsions, liposomes, nanoparticles, microspheres, nanocapsules, and micelles are being developed as new ophthalmic delivery systems [ 1 – 6 ]. These systems can enhance ocular drug bioavailability by promoting transcorneal penetration, but as with traditional eye drops, the same rapid rates of drainage that result in the rapid pre-corneal loss of the drug and consequently low bioavailability have been observed in these formulations.…”