Novaliq Receives Positive CHMP Opinion for Vevizye® in Dry Eye Disease
HEIDELBERG,
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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 0.1% solution, free of oils, surfactants, and preservatives, offering superior spreading properties and increased residual time on the ocular surface. This unique water-free therapy unfolds the full potential of ciclosporin to efficiently treat dry eye disease – fast and comfortable for patients.
“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
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. “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.”
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The Novaliq R&D pipeline provides multiple opportunities for development in ophthalmology and retina therapies.
Recommended Readings
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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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