Santen UK announced the launch of Verkazia eye drops emulsion containing 0.1% (1mg/ml) ciclosporin for the treatment of the rare disease severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents. Verkazia, which has been granted orphan drug status, provides a much-needed effective maintenance treatment option for this distressing and debilitating condition.
VKC is a chronic allergic eye condition, which predominantly affects children and young adolescents causing severe inflammation of the surface of the eye, resulting in intense itching, painful eyes and light sensitivity, limiting day-to-day life. Without adequate treatment, severe VKC, which represents around one-third of cases, can cause corneal ulcers and even vision loss, but there have been no suitable treatment options for its long-term management, according to Santen.
“We strongly welcome the launch of Verkazia, as it is one of the first eye drops to have a license for use in children with severe allergic eye disease known as vernal keratoconjunctivitis. This license is based on clear evidence of its beneficial effect in children with this condition which is becoming more common in the UK,” Abdul-Jabbar Ghauri, Consultant Ophthalmologist, Sandwell and West Birmingham Hospitals NHS Trust, said in a company news release. “We hope that the introduction of Verkazia will help to raise awareness of VKC and enable children to get the right diagnosis and treatment. It is reassuring to see Santen focusing on products for children and hope that this encourages other companies to take more of an interest in paediatric eye care.”
Unlike other licensed treatments, Verkazia is an immunomodulator that works by targeting the underlying cause of the inflammation at the surface of the eye, controlling the allergic response and inflammation. It has been shown to relieve the most common symptoms of VKC over a 12 month period. Verkazia is suitable for sustained use and has demonstrated a reduction in the need for rescue steroid therapy whilst also improving symptoms.
A pivotal phase 3 trial demonstrated that Verkazia significantly improved damage to the surface of the eye and reduced symptoms of severe VKC in children and adolescents (54% improvement vs. the control group given cationic emulsion, 2.06 vs. 1.34; P=0.007). Verkazia was shown to improve the main symptoms of VKC: 68% improvement in photophobia; 58% improvement in tearing; 72% improvement in itching; and 67% improvement in mucous discharge.
“We know how important this new treatment option is for children suffering from this serious and life-changing condition. Bringing it to the patients who desperately need it has been a top priority for Santen,” said Dr. Atiya Kenworthy, Medical Affairs, Santen. “We are so pleased to have reached this important milestone, building on Santen’s commitment to provide innovative eye medicines for real unmet medical needs.”
The European Commission granted approval for Verkazia in July 2018 as an orphan medicinal product for severe VKC, which has a rare disease status in Europe.
The recommended dose of Verkazia will be one drop to be administered four times a day to each affected eye, dosing morning, lunch time, afternoon, and before bedtime, 15 minutes after any other eye drops. The drops will be provided in boxes of 120 unit dose vials.