Santen launches Verkazia, providing much-needed treatment for children and adolescents with severe allergic eye condition
Thursday 25 October 2018 - Santen UK Limited (St Albans, UK) today launches 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.1 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 sensitivity2,3, limiting day-to-day life4. Without adequate treatment, severe VKC, which represents around one-third of cases5, can cause corneal ulcers and even vision loss, but there have been no suitable treatment options for its long-term management.
"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,” said Mr Abdul-Jabbar Ghauri, Consultant Ophthalmologist, Sandwell and West Birmingham Hospitals NHS Trust. “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.1 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.1
A pivotal phase III 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).6 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.7
“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.1 The drops will be provided in boxes of 120 unit dose vials.
- Verkazia SmPC. July 2018
- Kumar S. Vernal keratoconjunctivitis: a major review. Acta Ophthalmol 2009;87:133-147
- Leonardi A. Management of vernal keratoconjunctivitis. Ophthalmol Ther 2013;2:73-88
- Sacchetti M, et al. Development and testing of quality of life in children with vernal keratoconjunctivitis questionnaire. Am J Ophthalmol2007;144:557–563
- Bremond-Gignac D, et al. Prevalence of vernal keratoconjunctivitis: a rare disease? Br J Ophthalmol 2008;92:1097-1102
- Leonardi A, et al. Topical ciclosporin. A 1mg/mL cationic emulsion in the treatment of active severe vernal keratoconjunctivitis (VKC) in pediatric patients: results of the phase III VEKTIS study. 2017 Annual Meeting of the Association for Research in Vision and Ophthalmology; May 7–11, 2017; Baltimore, Maryland
- Santen, Data on File REF-1606.
As a specialised company dedicated to the ophthalmic field, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products and devices. Santen has long been the market leader in Japan for prescription ophthalmic pharmaceuticals and is now a leader in the sector in the EMEA (Europe, Middle East and Africa) region. With scientific knowledge and organisational capabilities nurtured over nearly 130 years, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society in more than 60 countries. For more information, please visit Santen websites www.santen.com (Japan headquarters) and www.santen.eu (EMEA).
About orphan designation
The European Medicine Agency’s (EMA) orphan designation programme is intended to encourage the development of medicines that may provide benefit to patients suffering from rare, life-threatening or chronically debilitating conditions.
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