Novaliq Receives Positive CHMP Opinion for Vevizye® in Dry Eye Disease
HEIDELBERG,

Novaliq Receives Positive CHMP Opinion for Vevizye® in Dry Eye Disease (Graphic: Business Wire)
Dry eye disease (DED) is one of the most common ocular surface disorders, affecting approximately 15 million diagnosed patients in the five largest European countries1 and is difficult to treat2. In
Vevizye®, development name CyclASol®, is a clear ciclosporin
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.
“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,” said Professor José M. Benítez del Castillo, Chair of the Department of Ophthalmology at University Complutense Madrid (
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
“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. “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
About Novaliq
Novaliq is a private biopharmaceutical company focusing on the development of first- and best-in-class 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 and are beginning to revolutionize patient care. 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.
The Novaliq R&D pipeline provides multiple opportunities for development in ophthalmology and retina therapies.
Novaliq is headquartered in Heidelberg,
Recommended Readings
- Global Data. Dry Eye Syndrome: Seven-Market Drug Forecast and Market Analysis Update | December 2022
- Jones et al. TFOS DEWSII Management and Therapy Report. The Ocular Surface. 2017; 15 (3): 575-628
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Sheppard et al. A Water-free
0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297 -
Akpek et al. Efficacy and Safety of a Water-Free Topical Cyclosporine,
0.1% , Solution for the Treatment of Moderate to Severe Dry Eye Disease The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmology. 2023; 141(5):459-466
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Source: Novaliq