See our press release today NOVALIQ AND LABORATOIRES THÉA ANNOUNCE PARTNERSHIP AND EU APPROVAL FOR VEVIZYE® (CICLOSPORIN 0.1% EYE DROPS SOLUTION) with our CEO, Christian Roesky, Dr. rer. nat, commenting on these exciting news below.
📢 I am thrilled to accounce that the European Commission approved Vevizye® (ciclosporin 0.1% eye drops solution) in Europe and also our new partnership with Laboratoires Théa to commercialise Vevizye® in Europe and selected countries in the Middle East and North Africa (MENA). Théa is a leading ophthalmic pharmaceutical company in Europe. Their focus on innovation, its leading commercial capabilities and the strong track record in Europe makes them the perfect partner for Novaliq GmbH to bring Vevizye® also to patients in Europe. The product was approved by the US Food and Drug Administration (FDA) in May 2023 as VEVYE® and is commercialized in the US by our partner Harrow. In the European Union (EU) the eligibility of Vevizye® to the centralised procedure under Article 3(2)(b) of Regulation (EC) No 726/2004 was based on the “interest of patients”. Vevizye® is indicated for the treatment of moderate to severe dry eye disease (keratoconjunctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes. Vevizye® is approved in all 27 EU member states. Full European Summary of Product Characteristics for Vevizye® is available from the EMA website at www.ema.europa.eu . At time of publication of this press release, the full SPCs may have not been yet published online. Additional regulatory applications are under review in several countries, including China, Australia, and New Zealand. For further details see the enclosed press release or visit www.Novaliq.com #innovation #dryeye #ophthalmology #Novaliq