Key Takeaways
- Novaliq and Laboratoires Théa announced that Vevizye® has been approved by the European Commission for the treatment of moderate to severe dry eye disease in adult patients, expanding its availability across the EU.
- Vevizye® utilizes Novaliq’s proprietary EyeSol® technology, making it the first and only water-free ciclosporin 0.1% eye drops solution, offering a new treatment option for patients who have not responded to tear substitutes.
- The approval is based on successful ESSENCE-1 and ESSENCE-2 trials, where Vevizye® showed significant improvements in corneal staining and dry eye symptoms, with up to 71.6% of patients responding within four weeks.
Novaliq, a biopharmaceutical company specializing in innovative ocular therapeutics, and Laboratoires Théa, Europe’s leading independent eye care group, have announced the European Commission’s approval of Vevizye® (ciclosporin 0.1% eye drops solution) for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca). Under the terms of their partnership, Théa has acquired the rights to commercialize Vevizye® across Europe and selected countries in the Middle East and North Africa (MENA).
Vevizye® is the first and only water-free ciclosporin 0.1% eye drops solution, utilizing Novaliq’s proprietary EyeSol® technology. It is indicated for adult patients whose dry eye disease has not improved with tear substitutes. This groundbreaking treatment offers a new solution for those suffering from moderate to severe dry eye disease, a condition that affects approximately 15 million patients across Europe and has long been challenging to manage with existing therapies.
Théa and Novaliq Partner to Launch Vevizye®, Addressing Unmet Needs in Dry Eye Disease Treatment
Jean-Frédéric Chibret, President of the Théa Group, highlighted the importance of the partnership: “Our collaboration with Novaliq reinforces our commitment to delivering innovative treatments to all patients. We are excited to launch Vevizye® as part of our range of non-preserved dry eye treatments, addressing a significant unmet need in the management of this condition.”
Christian Roesky, Ph.D., CEO of Novaliq, expressed his enthusiasm for the partnership, stating, “We are thrilled to partner with Théa, the leading ophthalmic pharmaceutical company in Europe, to bring Vevizye® to patients. Théa’s focus on innovation and its strong commercial capabilities make them the ideal partner to ensure the successful rollout of this treatment.”
Vevizye® Gains EU Approval Backed by Strong Clinical Trial Data, Highlighting Long-Term Efficacy in Dry Eye Disease
Vevizye®’s approval is supported by robust clinical data from two pivotal trials, ESSENCE-1 and ESSENCE-2. These randomized, multicenter, double-masked, vehicle-controlled studies demonstrated the efficacy of Vevizye® in reducing the signs and symptoms of dry eye disease. The primary endpoint in both trials was the reduction of total corneal fluorescein staining (tCFS) by Day 29, which was achieved with statistically significant results favoring Vevizye®. Notably, up to 71.6% of patients responded within four weeks with marked improvements in corneal staining.
Further improvements were observed in key secondary endpoints, including conjunctival and central corneal staining, at both Day 15 and Day 29, with continued improvement over up to 56 weeks, demonstrating Vevizye®’s long-term effectiveness in managing dry eye disease.
In addition to its recent European approval, Vevizye® was approved by the U.S. Food and Drug Administration (FDA) in May 2023 under the name VEVYE®. Additional regulatory applications are under review in several other countries, including China, Australia, and New Zealand, as Novaliq and Théa aim to expand global access to this innovative treatment for dry eye disease.
Resource: Laboratoires Théa, October 02, 2024
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