Scottish Medicines Consortium approves Verkazia for severe eye condition in children and adolescents
pharmafile | December 12, 2018 | News story | Research and Development, Sales and Marketing | SMC, Santen, Scotland, UK, Verkazia, pharma, vernal keratoconjunctivitis
UK-based pharmaceutical firm Santen has announced that the Scottish Medicines Consortium has awarded approval to its eye drops emulsion Verkazia (ciclosporin) for the treatment of severe vernal keratoconjunctivitis (VKC), a rare and chronic condition characterised by severe inflammation of the surface of the eye, in adolescents and children older than the age of four in Scotland.
The condition presents symptoms including intense itching and light sensitivity, and should it progress to a severe form as a result of inadequate treatment, as occurs in around a third of cases, it can cause corneal ulcers and vision loss.
The decision was based on Phase 3 data which showed that Verkazia “significantly improved damage to the surface of the eye” and improved symptoms of VKC by 54% compared to those receiving cationic emulsion alone. In addition, the drug also demonstrated a 63% improvement in light sensitivity symptoms, a 65% improvement in itching, a 67% improvement in discharge, and a 66% improvement in tearing.
“The approval of Verkazia is a game changer in Scotland,” explained Aravind Reddy, Consultant Ophthalmic Surgeon, Aberdeen Royal Infirmary and Royal Aberdeen Children’s Hospital. “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. 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.”
Verkazia previously secured marketing authorisation from the European Commission in July earlier this year.
“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” added 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.”
Matt Fellows
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