Santen launches Verkazia, to help kids break free from VKC (vernal keratoconjunctivitis)
October 25, 2018 - Santen UK Limited (St Albans, UK) today launches Verkazia® eye drops emulsion* for the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.1 Verkazia provides a much-needed effective ongoing treatment for this distressing and chronically debilitating condition, which is recognised as a rare disease and to date has had no long-term treatment option.
VKC is a chronic allergic eye condition, most common in children and adolescents, causing severe inflammation of the surface of the eye. The symptoms of VKC – intense itching, painful eyes and light sensitivity2,3 – can place a huge burden on those affected. The symptoms can prevent children from participating in everyday activities which can impact their development and quality of life.4 Without adequate treatment, severe VKC, which represents around one-third of cases5, can cause corneal ulcers and even vision loss.
"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.”
Verkazia (an immunomodulator) works differently to other licensed treatments, as it directly targets the underlying cause of the inflammation at the surface of the eye, controlling the allergic response and inflammation.1 It can be used over a sustained period of time which means that the use of steroids can be reduced.1 In clinical trials, Verkazia has been shown to significantly improve damage to the surface of the eye and reduce 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 light sensitivity; 58% improvement in tearing; 72% improvement in itching; and 67% improvement in 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 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 contains 0.1% (1mg/ml) ciclosporin
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 Ophthalmol 2007;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 Commission granted approval for Verkazia in July 2018 as an orphan medicinal product for VKC, which has a rare disease status in Europe. 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, lifethreatening or chronically debilitating conditions.
Date of preparation: October 2018 NP-VKC-UK-0027