Novaliq and Laboratoires Théa have announced approval from the European Commission (EC) for Vevizye (ciclosporin 0.1% eye drops solution) for patients with dry eye disease (DED) in Europe.
The partnership between the two companies has also been closed, with Théa acquiring the rights to commercialise Vevizye in Europe and selected Middle East and North African countries.
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Vevizye is the only water-free ciclosporin 0.1% eye drop solution that received approval in the EU to treat moderate to severe DED in adults who have not responded to tear substitute treatments.
Novaliq CEO Christian Roesky said: “Théa’s focus on innovation, its leading commercial capabilities and the strong track record in Europe makes them the perfect partner for Novaliq.”
DED affects an estimated 15 million diagnosed patients in the five largest European countries and presents a significant treatment challenge.
The efficacy of the product for treating DED was established through two randomised, double-masked, multicentre, vehicle-controlled studies, ESSENCE-1 and ESSENCE-2.
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By GlobalDataThe primary endpoint in both trials was the change from baseline in total corneal fluorescein staining (tCFS) score at Day 29.
Results showed a statistically significant reduction in tCFS, with up to 71.6% of patients experiencing clinical improvement within four weeks. Statistically significant effects were also observed in all other key secondary ocular surface sign endpoints.
In the US, the Food and Drug Administration approved the product as VEVYE in May 2023.
Vevizye received approval in all 27 EU member states.
In August 2023, the European Medicines Agency accepted Novaliq’s marketing authorisation application for CyclASol, another cyclosporine ophthalmic solution at 0.1%, as a treatment for DED.
