Novaliq, a biopharmaceutical company specializing in innovative ocular therapies using EyeSol® waterless technology, has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Vevizye®. This product is aimed at treating moderate to severe dry eye disease (DED) in adults, particularly when tear substitutes are insufficient.
“Clinical data for Vevizye® demonstrated significant improvements across the entire ocular surface within just two weeks, alongside an excellent tolerability profile and high treatment satisfaction,” said Professor José M. Benítez del Castillo, Chairman of Ophthalmology at Complutense University of Madrid.
DED is a prevalent eye condition affecting around 15 million people in major European countries, yet treatment options are scarce, with only one approved drug for severe keratitis associated with DED in Europe.
Vevizye®—the developmental name for CyclASol®—is a clear, 0.1% ciclosporin solution free from oils, surfactants, and preservatives. Its waterless formulation provides better spreading and a longer-lasting effect on the eyes. This novel approach maximizes ciclosporin’s efficacy in treating dry eye quickly and comfortably.
The positive CHMP opinion is based on data from over 1,500 patients with moderate to severe DED, reviewed following Novaliq’s July 2023 marketing authorization application. Vevizye® has shown clinically and statistically significant improvements in two multicenter studies (ESSENCE-1 and ESSENCE-2), including reductions in corneal fluorescein staining scores and substantial symptom relief within just two weeks. Up to 71.6% of patients saw meaningful improvement within four weeks, with continued benefits observed over 56 weeks.
“This CHMP opinion represents a significant milestone for Novaliq and our research into dry eye therapies. If approved, Vevizye® will be a pioneering waterless, cyclosporine-based treatment for dry eye in both the U.S. and EU,” stated Sonja Krösser, PhD, Vice President of Medical Science and Regulatory Affairs. “The rapid and sustained clinical benefits observed in most patients highlight the potential impact of Vevizye® on eye care.”
CyclASol®, marketed as Vevye™ in the U.S., was approved by the FDA in May 2023 and launched in January 2024 by Harrow (Nasdaq: HROW).
About Novaliq
Novaliq, headquartered in Heidelberg, Germany, with an office in Cambridge, USA, is a leader in developing advanced ocular therapeutics. The company’s EyeSol® technology enables waterless topical eye medications. Novaliq’s FDA-approved EyeSol® products, including Miebo™ and Vevye™, are transforming patient care. The company’s pipeline includes promising developments in ophthalmology and retinal therapies, with EyeSol® products undergoing regulatory review in various markets.
Dievini Hopp BioTech holding GmbH & Co. KG, a prominent investor in life sciences, is Novaliq’s long-term shareholder.
