Vekacia®
Ocular allergies affect more than 150 million people worldwide and the incidence appears to be on the increase possibly due to air pollution and allergens. Ocular allergic conditions vary from the subtle signs of itchy, watery eyes with mild hyperemia to extensive inflammation with corneal complications. Symptoms typically include itching and burning of the eyes with watery discharge.
Several forms of allergy have been identified. The most severe include rare pediatric form called Vernal Keratoconjunctivitis (VKC), on which we have chosen to focus our research efforts.
VKC is a severe form of chronic allergic conjunctivitis characterized by painful ocular discomfort and intense photophobia often impairing school performance, excessive eye tearing and giant papillae. Possible complications include secondary infection, corneal scarring and visual loss. This rare disease, which severely debilitates patients, affects mostly children and young adults.
Cyclosporine A is commonly used to reduce VKC’s symptoms but currently, medication is only available as hospital compounded formulation. We have developed Vekacia®, an improved Cyclosporine A product, which provides children patients with optimal safety, efficacy and comfort to bring them the care needed to eradicate this disease.
In March 2006, the European Medicines Agency (EMEA) recommended orphan drug designation in the European Union to Vekacia® for the treatment of VKC.
In May 2007, Novagali Pharma receives US FDA Orphan Drug Designation for Vekacia® for the treatment of Vernal Keratoconjunctivitis.
A phase III clinical trial in VKC patients with Vekacia® is completed. It should be the first product available in Europe for such a condition.