General Information

Verkazia (cyclosporine ophthalmic emulsion) 0.1% is a calcineurin inhibitor immunosuppressant.

Verkazia is specifically indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults.

Verkazia is supplied as an emulsion for topical ophthalmic use. 

General Dosing Information

• Gently shake the single-dose vial several times to obtain a uniform, white, opaque emulsion before use.
• Contact lenses should be removed before applying Verkazia and may be reinserted 15 minutes after administration.
• If a dose is missed, treatment should be continued as normal, at the next scheduled administration.
• If more than one topical ophthalmic product is being used, administer the eye drops at least 10 minutes apart to avoid diluting products.
• Administer Verkazia 10 minutes prior to using any eye ointment, gel or other viscous eye drops. Discard the vial immediately after use.

Recommended Dosage and Dose Administration

• Instill one drop of Verkazia, 4 times daily (morning, noon, afternoon, and evening) into each affected eye.
• Treatment can be discontinued after signs and symptoms are resolved and can be reinitiated if there is a recurrence

Mechanism of Action

Verkazia (cyclosporine ophthalmic emulsion) 0.1% is a calcineurin inhibitor immunosuppressant agent when administered systemically. Following ocular administration, cyclosporine is thought to act by blocking the release of pro-inflammatory cytokines such as IL-2. The exact mechanism of action in the treatment of VKC is not known.

Side Effects

Adverse effects associated with the use of Verkazia may include, but are not limited to, the following:

• eye pain
• eye pruitis

Clinical Trial Results

The FDA approval of Verkazia was based on two randomized, multi-center, double-masked, vehicle-controlled, clinical trials (VEKTIS Study and NOVATIVE Study). In the VEKTIS study, patients with severe VKC were randomized to four times daily of Verkazia 1 mg/mL or two times daily (BID) of Verkazia 1 mg/mL and vehicle group for the first 4 months (Period 1). In the NOVATIVE study, patients with moderate to severe VKC were randomized to QID of Verkazia 1 mg/mL or QID of cyclosporine ophthalmic emulsion 0.5 mg/mL and vehicle group for the first 1 month (Period 1). In both studies, patients randomized to the vehicle group were switched to Verkazia (QID or BID) from Month 4 to Month 12 in VEKTIS Study and to cyclosporine ophthalmic emulsion 0.5 mg/mL QID or 1 mg/mL from Month 1 to Month 4 in NOVATIVE Study (Period 2). In both studies, Verkazia demonstrated improvements in inflammation of the cornea (keratitis score) and ocular itching.