EC Approves Novaliq and Théa's Dry Eye Therapy

The European Commission (EC) has granted approval for Vevizye (ciclosporin 0.1% eye drops solution) for the treatment of dry eye disease (DED) in Europe, as announced by Novaliq and Laboratoires Théa. This approval marks a significant milestone in addressing the needs of patients with moderate to severe DED who have not found relief with conventional tear substitute treatments.

The collaboration between Novaliq and Laboratoires Théa has also been solidified, with Théa acquiring the rights to commercialize Vevizye across Europe and selected countries in the Middle East and North Africa. Novaliq's CEO, Christian Roesky, expressed confidence in Théa's ability to effectively bring Vevizye to market, citing their focus on innovation and strong commercial capabilities.

DED is a challenging condition affecting an estimated 15 million diagnosed patients in the five largest European countries. Vevizye stands out as the only water-free ciclosporin 0.1% eye drop solution approved in the EU for this condition, offering a new option for patients who have not responded to other treatments.

The efficacy of Vevizye was demonstrated in two rigorous clinical trials, ESSENCE-1 and ESSENCE-2. These studies were randomized, double-masked, multicentre, and vehicle-controlled, ensuring robust and reliable results. The primary endpoint in both trials was the change from baseline in total corneal fluorescein staining (tCFS) score at Day 29. The results indicated a statistically significant reduction in tCFS scores, with up to 71.6% of patients showing clinical improvement within just four weeks. Additionally, significant effects were observed in all other key secondary ocular surface sign endpoints, further confirming the product's effectiveness.

In the United States, the Food and Drug Administration (FDA) approved the product under the name VEVYE in May 2023. Following this, Vevizye has now received approval in all 27 EU member states, expanding its reach to a broader patient population.

Furthermore, in August 2023, the European Medicines Agency (EMA) accepted Novaliq’s marketing authorization application for CyclASol, another ciclosporin ophthalmic solution at 0.1% concentration, for the treatment of DED. This indicates Novaliq's ongoing commitment to developing effective treatments for dry eye disease and enhancing the quality of life for patients affected by this condition.