12.10.18

Santen Announces Scottish Medicines Consortium Approval of Verkazia for Severe Vernal Keratoconjunctivitis

Source: Santen

Santen UK announced that the Scottish Medicines Consortium (SMC) has approved Verkazia eye drops emulsion containing 0.1% (1mg/ml) ciclosporin for use by NHS Scotland for the treatment of the rare disease, severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents. 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. This approval by the SMC ensures that this much-needed treatment is available to Scottish patients living with this distressing and debilitating condition. 

VKC is a chronic allergic eye condition, most common in children and adolescents, causing severe inflammation of the surface of the eye. The symptoms – intense itching, painful eyes and light sensitivity2,3 – can place a huge burden on those affected, preventing participation in everyday activities and impacting development and quality of life.4

Without adequate treatment, severe VKC, which represents around one-third of cases,5 can cause corneal ulcers and even vision loss. Until now, there have been no suitable treatment options for its long-term management.  

“The approval of Verkazia is a game changer in Scotland. I see a significant number of children with VKC in my practice, and traditionally we have had to rely on unlicensed treatments to manage the disease,” Aravind Reddy, MD, Consultant Ophthalmic Surgeon, Aberdeen Royal Infirmary and Royal Aberdeen Children’s Hospital, said in a company news release. “Verkazia does not have the side-effects  associated with topical steroid use, and I am sure that parents and the healthcare profession are breathing a sigh of relief now that a licensed, effective treatment is available for this distressing disease.” 

Unlike other licensed treatments, Verkazia contains 0.1% ciclosporin, which 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 Verkazia also has an innovative cationic emulsion formulation which improves the absorption of ciclosporin. 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 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 alone, (2.06 vs. 1.34; p=0.007). Verkazia was shown to improve the main symptoms of VKC: 63% improvement in light sensitivity; 66% improvement in tearing; 65% improvement in itching; and 67% improvement in discharge.7

“The SMC decision to approve Verkazia marks a real turning point for everyone affected by this distressing condition in Scotland, providing, at last, an effective, licensed option which can be used to sustainably control the signs and symptoms of severe VKC” said Dr. Atiya Kenworthy, Medical Affairs, Santen. “We have worked hard in collaboration with the SMC and are delighted to put into practice Santen’s commitment to bring 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. 

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.

 

References

1.       Verkazia SmPC. July 2018

2.       Kumar S. Vernal keratoconjunctivitis: a major review. Acta Ophthalmol 2009;87:133-147

3.       Leonardi A. Management of vernal keratoconjunctivitis. Ophthalmol Ther 2013;2:73-88

4.       Sacchetti M, et al. Development and testing of quality of life in children with vernal keratoconjunctivitis questionnaire. Am J Ophthalmol 2007;144:557-563 

5.       Bremond-Gignac D, et al. Prevalence of vernal keratoconjunctivitis: a rare disease? Br J Ophthalmol 2008;92:1097-1102

6.       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

7.       Santen, Data on File REF-1606

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