Novaliq and European eye care group Laboratoires Théa have received the European Commission (EC) approval for Vevizye (ciclosporin 0.1% eye drops solution).
The approval is for patients with moderate to severe dry eye disease (DED) (keratoconjunctivitis sicca) who showed no improvement with tear substitutes.
Germany-based Novaliq and Laboratoires Théa have also concluded a partnership. Under this agreement, the eye care group will commercialise Vevizye in Europe and select countries in the Middle East and North Africa (MENA).
Vevizye uses Novaliq’s EyeSol technology. It is now said to be the only water-free ciclosporin 0.1% eye drop solution approved in the European Union (EU).
It was approved by the US Food and Drug Administration (FDA) in May 2023.
In July, the German biopharmaceutical company received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding marketing authorisation for the eye drops solution.
Laboratoires Théa group president Jean-Frédéric Chibret said: “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.”
Vevizye’s effectiveness was shown in randomised, multicentre, double-masked, vehicle-controlled ESSENCE-1 and ESSENCE-2 studies.
The primary endpoint was the change in total corneal fluorescein staining (tCFS) score on Day 29 in both trials.
Both studies showed a statistically significant reduction in tCFS for Vevizye. Up to 71.6% of patients experienced clinical improvement within four weeks.
Key secondary endpoints, including conjunctival staining and central corneal staining, also showed benefits for ciclosporin.
Improvements in signs and symptoms of dry eye disease continued for up to 56 weeks.
Novaliq CEO Christian Roesky said: “We are thrilled to partner with Théa, the leading ophthalmic pharmaceutical company in Europe, to bring Vevizye to patients.
“Théa’s focus on innovation, its leading commercial capabilities and the strong track record in Europe makes them the perfect partner for Novaliq.”
Additional regulatory applications are currently under review in countries like China, Australia, and New Zealand.
In August last year, the EMA accepted Novaliq’s marketing authorisation application for CyclASol, an investigational new drug for dry eye disease.
