With the FDA’s authorization recently of cyclosporine ocular emulsion 0.1%, ophthalmologists now have an additional choice to treat their patients, both adults as well as kids, with fresh keratoconjunctivitis (VKC), a sensitive eye problem that if left neglected can bring about corneal shield ulcers and potentially vision loss.
The treatment, which will be offered by prescription only, is available in an oil-in-water cationic solution. It provides improved eye bioavailability of cyclosporine, according to the manufacturer.
The treatment hinders T-cell activation and decreases the degree of immune cells and mediators that cause allergic inflammation of the eye surface.
The treatment was evaluated in two randomized, multicenter, double-masked, vehicle-controlled clinical trials: the VEKTIS study and the NOVATIVE study.
A news release provided by the manufacturer explained the research study details: in the VEKTIS research study, patients with serious VKC were randomly designated to get Verkazia 1 mg/mL 4 times daily or two times daily and also vehicle group for the first 4 months (period 1).
The NOVATIVE study included patients with moderate to severe VKC that were randomly designated to obtain Verkazia 1 mg/mL four times daily or cyclosporine ophthalmic emulsion 0.5 mg/mL 4 times daily as well as vehicle group for the first month (period 1).
Patients who had actually been assigned to the vehicle group were changed to Verkazia (4 times daily or twice daily) from month 4 to month 12 in the VEKTIS research as well as 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, the emulsion produced improvements in inflammation of the cornea, as measured by keratitis score, and in ocular itching, thus proving efficacy in treatment. Adverse reactions that were reported in > 5% of patients were eye discomfort (12%) and eye pruritus (8%), which were usually transient.
Treatment for VKC is long term because the condition is recurring. It is therefore vital that the treatment works and is well tolerated by patients and is risk-free to use throughout a patient’s life, according to Guillermo Rocha, MD, FRCSC, FACS, an eye doctor and professor.
Verkazia appeared for prescription usage in Canada in 2020. Rocha has been recommending 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 make use of long-term safely and efficiently without systemic or local adverse effects, so a really safe & effective treatment, so to say.”
Topical steroids are effective in the treatment of VKC, yet Rocha explained that their prolonged use carries many risks. “You cannot utilize them long-term,” he said. “They produce a kind of localized immune suppression that can result in infections in the eye or cataracts or high intraocular pressure, all of which are potentially risky and undesirable.”
Rocha noted that he and other medical professionals made use of to compound 1% cyclosporine to treat VKC, but the formulation was far from optimum, in relation to bioavailability as well as tolerability. “It was not perfectly made for the eye, and we had problems while using it” claimed Rocha. “Now we have 0.1% emulsion made specifically for the eye. It’s preservative free, which is what you desire for a condition that involves allergy. It does not cause any reactions. It is one tenth of what we were using before, as we used a 1% solution.”
The treatment will certainly halt the progression of VKC to various other ocular pathologies, such as corneal shield ulcers, according to Rocha.
“Anytime we can avoid serious disease on the cornea that can trigger scarring or corneal opacification, that is a good thing,” he claimed.
The signs of VKC are often triggered or worsened by seasonal allergic reactions during the summer season and fall, said Rocha. Patients can begin the treatment when they have flares and they can stop the treatment when the disease is not active, he added.
“If patients remain in an active allergenic condition, they may have a worsening condition,” said Rocha. “When winter months approach, they will feel better. They can begin treatment, stop it for a couple of months, and afterwards go back to it if needed.”
There is no risk of response reducing after a medicine discontinuance, said Rocha.