Novaliq Receives Positive CHMP Opinion for Vevizye® in Dry Eye Disease
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye®, intended for the treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes.
Vevizye® (Novaliq) will be available as 1 mg/ml eye drops solution. The active substance of Vevizye is ciclosporin, which has anti-inflammatory and immunosuppressive properties. In a main study, the benefit of Vevizye was a reduction in corneal surface damage in patients with dry eye disease, as evidenced by an improvement in the total corneal fluorescein staining score compared to the placebo group. The most common side effects with Vevizye are instillation site reactions and blurred vision.
"Vevizye®, development name CyclASol®, is a clear ciclosporin 0.1% solution, free of oils, surfactants, and preservatives, offering superior spreading properties and increased residual time on the ocular surface", Novaliq stated in a press release. "This unique water-free therapy unfolds the full potential of ciclosporin to efficiently treat dry eye disease – fast and comfortable for patients."
Novaliq submitted a Marketing Authorisation Application (MAA) for Vevizye® in July 2023 under the centralised procedure. The positive opinion is based on the CHMP review of the comprehensive data package from more than 1.500 patients with moderate to severe DED.
Professor José M. Benítez del Castillo, PhD, Chair of the Department of Ophthalmology at University Complutense Madrid, Spain, comments in the press release: “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 clinically meaningful and statistically significant improvements in moderate and severe DED patients in two independent adequate and well-controlled, multicenter studies (ESSENCE-13 and ESSENCE-24) across various endpoints. These included effects on the ocular surface with a statistically significant reduction in total corneal fluorescein staining score favoring Vevizye® as early as on Day 15. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement in total corneal fluorescein staining. Responders showed statistically significant improvements in a variety of symptoms compared to non-responding patients within four weeks. Continued and relevant improvement under therapy in both signs and symptoms of DED were demonstrated over a period of up to 56 weeks, confirming Vevizye®’s favorable tolerability and efficacy profile.
“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 authorisation 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 the US and EU,” said Sonja Krösser, PhD, Vice President Medical Science and Regulatory Affairs in the press release. “DED is a serious and difficult to treat condition. Clinically meaningful outcomes in the majority of patients are key differentiators for eyecare providers, patients and payers. Vevizye® demonstrated across multiple studies that most patients benefit from the therapy already after two weeks showing continued improvements over 12 months in both signs and symptoms.”
In May 2023 the United States Food and Drug Administration (FDA) approved CyclASol® under the brand name Vevye™. The product was successfully launched in the United States in January 2024 by Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company.
About Novaliq
Novaliq is a private biopharmaceutical company focusing on the development of ocular therapeutics. Novaliq developed EyeSol®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol® medicinal products for dry eye disease – Miebo™ and Vevye™ – have recently been launched in clinical practices of eyecare professionals in the US. The EyeSol®-based products for dry eye disease are successfully partnered in major markets and are under regulatory review in several further countries and regions.
Novaliq is headquartered in Heidelberg, Germany and has an office in Cambridge, MA, USA.