Novaliq receives positive CHMP opinion for ciclosporin 0.1% solution, Vevizye

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Novaliq announced it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for ciclosporin 0.1% solution, Vevizye, for the treatment of dry eye disease (DED) in adult patients which have not improved despite treatment with tear substitutes.

The positive opinion from the CHMP comes with the recommendation that Vevizye be granted marketing authorization in the European Union.

Dry eye treatments are limited in Europe, as only 1 drug therapy is approved in the EU, which is restricted to the treatment of severe keratitis associated with DED.¹

Professor José M. Benítez del Castillo, PhD, Chair of the Department of Ophthalmology at University Complutense Madrid, Spain, discussed the news in a press release from Novaliq.

“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 Benítez del Castillo. ”I am enthusiastic that there will be a new treatment option addressing these important aspects of a dry eye therapy in Europe.”

Vevizye, which was developed under the name CyclASol, is a ciclosporin 0.1% solution, free of oils, surfactants, and preservatives. Novaliq states that “this unique water-free therapy unfolds the full potential of ciclosporin to efficiently treat dry eye disease [which is] fast and comfortable for patients.”

Novaliq submitted the Marketing Authorisation Application (MAA) for Vevizye in July 2023. The positive opinion is based on a comprehensive data package submitted by Novaliq, containing more than 1,500 patients with moderate to severe DED.^1,2

In the ESSENCE-1and ESSENCE-2 clinical trials, Vevizyedemonstrated clinically meaningful and statistically significant improvements in moderate and severe DED patients. A statistically significant reduction in total corneal fluorescein staining score favoring Vevizyewas seen as early as day 15, while up to 71.6% of patients responded within 4 weeks with a clinically meaningful improvement in total corneal fluorescein staining.

Sonja Krösser, PhD, Vice President Medical Science and Regulatory Affairs for Novaliq said the “positive CHMP opinion for Vevizyemarks 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.”

Vevye was approved by the US Food and Drug Administration in May 2023, and launched in the US by Harrow.

References:

1. Novaliq Receives Positive CHMP Opinion FOR Vevizye® in Dry EYE Disease. Press Release; July 29, 2024. Accessed July 29, 2024. https://www.novaliq.com/press-releases/2024/07/29/novaliq-receives-positive-chmp-opinion-for-vevizye-in-dry-eye-disease/

2. EMA Press Release. Vevizye. Released July 25, 2024. Accessed July 29, 2024. https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vevizye_en.pdf