Novaliq’s Vevizye® Receives Positive CHMP Opinion for Dry Eye Disease
Novaliq announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending the granting of a marketing authorization for Vevizye® in the European Union. This therapy is designed to treat moderate to severe dry eye disease (DED) in adult patients who have not seen improvement with tear substitutes.
Significance of Vevizye® in Treating Dry Eye Disease
Dry eye disease is a common ocular surface disorder, impacting approximately 15 million diagnosed patients in the five largest European countries. Despite its widespread occurrence, effective treatment options in Europe are currently limited, with only one approved drug therapy available for severe keratitis associated with DED.
Vevizye®, known during development as CyclASol®, is a clear ciclosporin 0.1% solution that stands out due to its absence of oils, surfactants, and preservatives. This water-free formulation enhances the spreading properties and extends the residual time of the therapy on the ocular surface, potentially offering significant benefits for patients suffering from dry eye disease.
Clinical Data and Research Findings
Novaliq submitted the Marketing Authorisation Application (MAA) for Vevizye® in July 2023 through the centralized procedure. The positive CHMP opinion is based on a thorough review of clinical data from over 1,500 patients with moderate to severe DED.
Professor José M. Benítez del Castillo, Chair of the Department of Ophthalmology at University Complutense Madrid, praised the therapy: “Clinical data for Vevizye® showed clinically meaningful improvements of the ocular surface as early as two weeks, combined with an excellent tolerability profile and high treatment satisfaction. I am enthusiastic that there will be a new treatment option addressing these important aspects of a dry eye therapy in Europe.”
Vevizye® demonstrated significant improvements in moderate and severe DED patients in two independent, well-controlled multicenter studies (ESSENCE-13 and ESSENCE-24). Key findings include:
● Early Improvement: A statistically significant reduction in total corneal fluorescein staining score as early as Day 15.
● High Response Rate: Up to 71.6% of patients experienced a clinically meaningful improvement within four weeks.
● Long-Term Benefits: Continued improvement in both signs and symptoms of DED was observed over a period of up to 56 weeks, affirming Vevizye®’s favorable tolerability and efficacy.
Novaliq's Vision and Future Prospects
Sonja Krösser, PhD, Vice President of Medical Science and Regulatory Affairs at Novaliq, highlighted the significance of this development: “The positive CHMP opinion for Vevizye® marks a major achievement and the pinnacle of our extensive research in dry eye disease therapies. If the marketing authorization in the EU is formally granted, this unique water-free ciclosporin therapy will be the first medicinal therapy approved to treat dry eye disease in both the US and EU.”
Vevizye® received approval from the United States Food and Drug Administration (FDA) in May 2023 under the brand name Vevye™. It was successfully launched in January 2024 by Harrow, a leading U.S. eyecare pharmaceutical company.
