Vevizye (Ciclosporin 0.1%) Receives European Commission Approval for Dry Eye Disease
Key Insights
Novaliq (search) and Laboratoires Théa secured European Commission approval for Vevizye (ciclosporin 0.1% eye drops) for moderate to severe dry eye disease (search).
Vevizye, utilizing Novaliq (search)’s EyeSol technology, is the first water-free ciclosporin 0.1% eye drop approved in the EU for this condition.
Clinical trials (ESSENCE-1 and ESSENCE-2) demonstrated statistically significant reduction in corneal fluorescein staining with Vevizye treatment.
The European Commission has granted approval for Vevizye (ciclosporin 0.1% eye drops solution) for the treatment of moderate to severe dry eye disease (search) (DED) in adult patients who have not responded adequately to tear substitutes. This approval marks a significant advancement in the treatment of DED, offering a new option for millions of affected individuals across Europe. The approval extends to all 27 EU member states.
Novaliq (search), the developer of Vevizye, has entered into a partnership with Laboratoires Théa, a leading European eye care group, for the commercialization of Vevizye in Europe and selected countries in the Middle East and North Africa (MENA). This collaboration aims to leverage Théa's extensive network and expertise in the ophthalmic market to ensure broad access to this innovative therapy.
Vevizye is based on Novaliq (search)’s EyeSol technology, which allows for a water-free formulation of ciclosporin 0.1%. This unique formulation is designed to improve drug delivery and efficacy in treating the underlying inflammation associated with dry eye disease (search). It is the only water-free ciclosporin 0.1% eye drop solution approved in the European Union.
Clinical Efficacy
The efficacy of Vevizye in treating DED was demonstrated in two pivotal Phase 3 clinical trials, ESSENCE-1 and ESSENCE-2. These studies were randomized, multicenter, double-masked, and vehicle-controlled, evaluating the change from baseline in total corneal fluorescein staining (tCFS) score at Day 29 as the primary endpoint.
Both trials met their primary endpoint, showing a statistically significant reduction in tCFS with Vevizye compared to the vehicle. Specifically, up to 71.6% of patients experienced clinical improvement within four weeks of treatment. Key secondary endpoints, including conjunctival staining and central corneal staining, also showed statistically significant benefits favoring Vevizye.
In the ESSENCE-2 study, which included 834 patients with moderate to severe DED, patients were randomized to either Vevizye (n=423) or vehicle (n=411) following a 14-day run-in period. The study, conducted across 27 US sites, demonstrated significant improvements in tCFS and dryness scores at day 29 compared to baseline.
Addressing Unmet Needs in Dry Eye Disease
Dry eye disease (search) is a prevalent condition, affecting an estimated 15 million diagnosed patients in the five largest European countries. Characterized by chronic dryness and discomfort of the ocular surface, DED can significantly impair vision and quality of life. Current treatments often provide only symptomatic relief, highlighting the need for therapies that target the underlying pathophysiology of the disease.
"Our partnership with Novaliq (search) highlights our dedication to delivering innovative treatments to all patients," said Jean-Frédéric Chibret, President of the Théa Group. "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 (search), added, "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."
Regulatory Status and Future Plans
Vevizye was approved by the US Food and Drug Administration (FDA) in May 2023 under the brand name VEVYE. Additional regulatory applications are currently under review in several countries, including China, Australia, and New Zealand. Novaliq (search) is also pursuing EMA approval for CyclASol, another cyclosporine ophthalmic solution at 0.1%, as a treatment for DED.