FDA Approves Verkazia for Vernal Keratoconjunctivitis, an Allergic Eye Disease

Louise Gagnon

June 28, 2021

With the FDA's approval last week of cyclosporine ophthalmic emulsion 0.1% (Verkazia), ophthalmologists now have another option to treat their patients, both adults and children, with vernal keratoconjunctivitis (VKC), an allergic eye condition that if left untreated can lead to corneal shield ulcers and potentially vision loss.

The therapy, which will be available by prescription only, comes in an oil-in-water cationic emulsion. It offers improved ocular bioavailability of cyclosporine, according to Santen Inc, the manufacturer.

The therapy inhibits T-cell activation and decreases the level of immune cells and mediators that lead to allergic inflammation of the ocular surface.

The treatment was assessed in two randomized, multicenter, double-masked, vehicle-controlled clinical trials: the VEKTIS study and the NOVATIVE study.

A press release issued by the manufacturer described the study details: in the VEKTIS study, patients with severe VKC were randomly assigned to receive Verkazia 1 mg/mL four times daily or two times daily and vehicle group for the first 4 months (period 1).

The NOVATIVE study involved patients with moderate to severe VKC who were randomly assigned to receive Verkazia 1 mg/mL four times daily or cyclosporine ophthalmic emulsion 0.5 mg/mL four times daily and vehicle group for the first month (period 1).

Patients who had been assigned to the vehicle group were switched to Verkazia (four times daily or twice daily) from month 4 to month 12 in the VEKTIS study and to cyclosporine ophthalmic emulsion 0.5 mg/mL four times daily or 1 mg/mL from month 1 to month 4 in the NOVATIVE study (period 2).

In both studies, Verkazia produced improvements in inflammation of the cornea, as measured by keratitis score, and in ocular itching. Adverse reactions that were reported in >5% of patients were eye pain (12%) and eye pruritus (8%), which were usually transient.

Treatment for VKC is long term because the condition is recurrent. It is therefore vital that therapy is effective and well tolerated by patients and is safe to use throughout a patient's life, according to Guillermo Rocha, MD, FRCSC, FACS, an ophthalmologist and professor in the Department of Ophthalmology, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada; medical director and past president of the Canadian Ophthalmological Society; and president of the Canadian Ophthalmological Society Foundation.

Verkazia became available for prescription use in Canada in 2020. Rocha has been prescribing it for the past year and noted that it has made a big difference for his patients who have VKC. "They are tolerating it well," he said. "They have a treatment they can use long term safely and effectively without systemic or local side effects."

Topical steroids are effective in the treatment of VKC, but Rocha pointed out that their prolonged use carries many risks. "You can't use them long term," he said. "They produce a type of localized immune suppression that can lead to infections or cataracts or high intraocular pressure."

Rocha noted that he and other clinicians used to compound 1% cyclosporine to treat VKC, but the formulation was far from optimal with respect to bioavailability and tolerability. "It was not perfectly made for the eye," said Rocha. "Now we have 0.1% emulsion made specifically for the eye. It's preservative free, which is what you want for a condition that involves allergy. It doesn't cause any reactions. It is one tenth of what we were using before, as we used a 1% solution."

The therapy will halt the progression of VKC to other ocular pathologies, such as corneal shield ulcers, according to Rocha.

"Anytime we can prevent serious disease on the cornea that can cause scarring or corneal opacification, that is a good thing," he said.

The symptoms of VKC are often triggered or exacerbated by seasonal allergies during the summer and fall, noted Rocha. Patients can start the therapy when they have flares and stop therapy when the disease is not active, he added.

"If patients are in an active allergenic environment, they may have an exacerbation," said Rocha. "When winter arrives, then they will feel better. They can start therapy, stop it for a few months, and then go back on it if needed."

There is no risk of response diminishing after a drug holiday from Verkazia, explained Rocha.

Rocha has disclosed no relevant financial relationships.

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