Novaliq receives positive CHMP opinion for dry eye treatment Vevizye

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Biopharmaceutical company Novaliq has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the recommendation to grant a marketing authorization in the European Union (EU) for Vevizye.¹ The positive opinion developed from the CHMP review was based off a comprehensive data package from more than 1500 patients with moderate to severe dry eye disease (DED), according to a news release.

The clear ciclosporin 0.1% solution, commercially launched under the name Vevye in the US in January 2024, is intended for the treatment of moderate to severe DED in adult patients.¹ Vevye is free of oils, surfactants, and preservatives and is a water-free therapy, allowing an increased residual time on the ocular surface, the release stated.

“Clinical data for Vevizyeshowed clinically meaningful improvements of the ocular surface as early as 2 weeks, combined with an excellent tolerability profile and high treatment satisfaction,” said José M. Benítez del Castillo, MChD, chair of the Department of Ophthalmology at University Complutense Madrid in Spain, in the release. “I am enthusiastic that there will be a new treatment option addressing these important aspects of a dry eye therapy in Europe.”

The US FDA approved CyclASol, the development name of Vevye, in May 2023. Novaliq had previously submitted a Marketing Authorization Application for Vevizye in July 2024 under the centralized procedure.¹

“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 the US and EU,” said Sonja Krösser, PhD, Novaliq’s vice president of Medical Science and Regulatory Affairs, in the release. “DED is a serious and difficult to treat condition. Clinically meaningful outcomes in the majority of patients are key differentiators for eye care providers, patients and payers. Vevizye demonstrated across multiple studies that most patients benefit from the therapy already after 2 weeks showing continued improvements over 12 months in both signs and symptoms.”

The studies that demonstrated these statistically significant results were the ESSENCE-1 and ESSENCE-2 studies, which included corneal fluorescein staining scores that favored Vevye as early as on day 15. Additionally, up to 71.6% of patients responded within 4 weeks with clinically meaningful improvement in total corneal fluorescein staining.¹

Reference:

1. Novaliq receives positive CHMP opinion for Vevizye in dry eye disease. News release. Novaliq. July 29, 2024. Accessed August 5, 2024. https://www.novaliq.com/press-releases/2024/07/29/novaliq-receives-positive-chmp-opinion-for-vevizye-in-dry-eye-disease/