Novaliq and Laboratoires Théa Team Up for Innovative Eye Drops
Novaliq and Laboratoires Théa Join Forces for Eye Care
Novaliq, a pioneering biopharmaceutical company, is excited to announce a significant partnership with Laboratoires Théa, a leader in ophthalmic treatments. This collaboration marks a remarkable advancement in the fight against dry eye disease as they jointly unveil the approval of Vevizye® (ciclosporin 0.1% eye drops solution) by the European Commission.
Vevizye®: A Breakthrough in Dry Eye Treatment
Vevizye® is the first and only water-free ciclosporin formulation approved within the European Union to address moderate to severe dry eye disease, particularly when previous treatments, including tear substitutes, have not yielded improvements. This innovative solution, designed using Novaliq’s proprietary EyeSol® technology, signifies hope for the millions suffering from this common ocular condition.
Commitment to Innovation
Jean-Frédéric Chibret, President of the Théa Group, expressed enthusiasm about their partnership, stating, "Our work with Novaliq underscores our commitment to providing innovative therapies to patients who need them most. By launching Vevizye®, we are enhancing our already impressive suite of non-preserved treatments for dry eye disease, thus improving the quality of life for many individuals."
Understanding Dry Eye Disease
Dry eye disease, affecting around 15 million individuals across major European nations, presents complex treatment challenges. The need for effective prescription solutions in Europe has never been more pressing, and with Vevizye®, patients will have access to a groundbreaking treatment that addresses this frustrating condition.
Strategic Clinical Study Results
The efficacy of Vevizye® was rigorously demonstrated through two robust randomized clinical trials, known as the ESSENCE studies. These multicenter studies not only showcased the product's effectiveness but also highlighted patients’ significant improvements after just 29 days of treatment, with 71.6% showing notable clinical response.
Further Evidence of Success
Measuring total corneal fluorescein staining (tCFS) was the primary focus, and outcomes significantly favored Vevizye® across all key secondary endpoints assessed during these studies. Continued therapeutic improvements in ocular signs and symptoms were documented for up to 56 weeks, underscoring the durable benefits of this innovative treatment.
The Approval Journey of Vevizye®
Noteworthy is Vevizye®'s approval journey, produced by the U.S. Food and Drug Administration (FDA) in May 2023 as VEVYE®. The product's significance was further bolstered through eligibility for the centralized procedure within the EU, allowing rapid access for patients in all 27 member states.
Future Regulatory Applications
Novaliq is broadening its impact by pursuing additional regulatory applications for Vevizye® in countries such as China, Australia, and New Zealand, demonstrating their commitment to expanding patient access to innovative treatments worldwide.
About Novaliq
With headquarters in Heidelberg, Germany, Novaliq is a leading private biopharmaceutical company driven to develop best-in-class ocular therapeutics. Particular emphasis is placed on their patented EyeSol® technology—revolutionizing the delivery of topical eye medications. With FDA-approved products like Miebo® and Vevye®, Novaliq continues to reshape the landscape of eye care.
About Laboratoires Théa
Laboratoires Théa is recognized as an independent leader in eye care in Europe, deeply committed to research and development. Through its expansive network of affiliates, Théa has successfully launched its products in 75 countries, showcasing remarkable growth with a turnover of €923 million in 2023. This company aims to make impactful advancements in eye health globally.
Frequently Asked Questions
What is Vevizye® used for?
Vevizye® is indicated for treating moderate to severe dry eye disease in patients unresponsive to conventional tear substitutes.
What technology is used in Vevizye®?
This product utilizes Novaliq's proprietary EyeSol® technology, which allows for a water-free formulation enhancing efficacy.
Who partnered with Novaliq for this treatment?
Laboratoires Théa entered into a partnership with Novaliq to commercialize Vevizye® across Europe and certain regions in MENA.
How do Vevizye®'s clinical studies measure success?
Success is measured through significant reductions in total corneal fluorescein staining scores after treatment, demonstrating improvements in dry eye symptoms.
Where is Novaliq headquartered?
Novaliq is headquartered in Heidelberg, Germany, with operations extending to Cambridge, Massachusetts, USA.
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