Novaliq and Laboratoires Théa announce European Commission approval of ciclosporin 0.1% eye drops solution

Ciclosporin 0.1% solution was approved by the US FDA in May 2023 under the brand name VEVYE. ©rocketclips – stock.adobe.com

Novaliq and Laboratoires Théa announced European Commission approval of ciclosporin 0.1% eye drops solution (Vevizye) for the treatment of dry eye disease (DED) in Europe. On top of the approval, the two companies have announced a partnership in which Laboratoires Théa will acquire the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa.¹

Ciclosporin 0.1% eye drops solution was approved by the US Food and Drug Administration (FDA) in May 2023 under the brand name VEVYE.² In the EU, ciclosporin 0.1% eye drops solution will be marketed under the name Vevizye for the treatment of moderate to severe DED in adult patients which has not improved despite treatment with tear substitutes.

Efficacy of Vevizye was shown in the ESSENCE-1 and ESSENCE-2 clinical trials. Both were randomised, multicentre, double-masked, vehicle-controlled studies with change from baseline in total corneal fluorescein staining (tCFS) score at Day 29 being the primary endpoint.

The ESSENCE-2 study included 834 patients with moderate to severe DED who were randomized to active treatment (n=423) or vehicle (n=411) following a 14-day run-in period during which they instilled an artificial tear twice daily. The patients instilled either cyclosporine or vehicle twice daily for 29 days and the results were compared.

The study period ran from 5 December, 2020, to 8 October, 2021, at 27 US sites. The primary endpoints were the changes in the tCFS (0-15 [best to worst] on the National Eye Institute scale) and in the dryness score (0-100 [best to worst] on the visual analogue scale) at day 29 compared with baseline. The investigators also evaluated the conjunctival staining, central corneal fluorescein staining and the tCFS responders.

Jean-Frédéric Chibret, President of the Théa Group, commented on the partnership in a joing press release from the companies, stating, "Our partnership with Novaliq highlights our dedication to delivering innovative treatments to all patients. We are looking forward to launching Vevizye to complement our range of non-preserved treatments for dry eye, a disease that has substantial impacts on the quality of life of many patients."

Christian Roesky, PhD, CEO of Novaliq, also provided a statement, saying, "We are thrilled to partner with Théa, the leading ophthalmic pharmaceutical company in Europe, to bring Vevizye to patients.”

Vevizye is approved in all 27 EU member states.

References:

1. Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye® (Ciclosporin 0.1% Eye Drops Solution). Press Release; October 2, 2024. Accessed October 2, 2024. https://www.businesswire.com/news/home/20241002958802/en/Novaliq-and-Laboratoires-Th%C3%A9a-Announce-Partnership-and-EU-Approval-for-Vevizye%C2%AE-Ciclosporin-0.1-Eye-Drops-Solution

2. Hutton, D. FDA approves Novaliq’s cyclosporine ophthalmic solution for treatment of dry eye disease. Ophthalmology Times. Published June 8, 2023. Accessed October 2, 2024. https://www.ophthalmologytimes.com/view/fda-approves-novaliq-s-cyclosporine-ophthalmic-solution-for-treatment-of-dry-eye-disease