European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (ciclosporin ophthalmic solution) 0.1% for the Treatment of Dry Eye Disease
Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU).
Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment. In the EU only one drug therapy limited to a subset of DED patients with severe keratitis is currently approved.
CyclASol is ciclosporin, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. Dispensed in a unique 10 microliter small drop the solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity.
“Our in Heidelberg, Germany, invented water-free technology was designed to unfold the full potential of pharmaceuticals on the ocular surface,” said Christian Roesky, Ph.D., Chief Executive Officer of Novaliq. “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.”
The clinical development program for the MAA is based on six clinical studies, which evaluated the safety and efficacy of CyclASol in a total of 1,575 patients with dry eye disease. Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED. Continued improvement under therapy in both signs and symptoms of DED has been clinically demonstrated over a period of up to 56 weeks in an extension study of ESSENCE‑2. With its early onset of effect and its good tolerability profile CyclASol addresses unmet medical needs in DED.
CyclASol was approved by the U.S. Food and Drug Administration (FDA) as VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 30, 2023. VEVYE is the first and only FDA approved cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment and is commercialized in Northern America by Harrow Health Inc, a leading U.S. eyecare pharmaceutical company.
Novaliq is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free ophthalmic technology.
Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases based on its proprietary water-free eyedrop technology. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023.
Novaliq GmbH is headquartered in Heidelberg, Germany, and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on novaliq.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Novaliq Media Contact:
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Takeda Provides Update on EXKIVITY® (mobocertinib)2.10.2023 23:30:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will be working with the FDA towards a voluntary withdrawal of EXKIVITY ® (mobocertinib) in the U.S. for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy. Takeda intends to similarly initiate voluntary withdrawal globally where EXKIVITY is approved and is working with regulators in other countries where it is currently available on next steps. This decision was based on the outcome of the Phase 3 EXCLAIM-2 confirmatory trial, which did not meet its primary endpoint and thus did not fulfill the confirmatory data requirements of the Accelerated Approval granted by the U.S. FDA nor the conditional marketing approvals granted in other countries. The EXCLAIM-2 trial was a Phase
Galderma announces progress with RelabotulinumtoxinA regulatory submissions2.10.2023 23:27:00 EEST | Press release
Galderma, the emerging pure-play dermatology category leader, announced today updates related to the regulatory progress of its pending Biologics License Application (“BLA”) for RelabotulinumtoxinA (QM-1114) to the U.S. Food and Drug Administration (“FDA”). The FDA has issued a Complete Response Letter (“CRL”) to Galderma related to its BLA for RelabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines (frown lines) associated with corrugator and/or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis oculi muscle activity in adult patients. The CRL points out certain deficiencies isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. All other aspects of the BLA, including safety and efficacy related parts, did not solicit deficiencies to be addressed. Galderma has already identified changes to the manufacturing process to address feedback. It will also
Visa Launches $100 million Generative AI Ventures Initiative2.10.2023 23:05:00 EEST | Press release
Visa (NYSE: V), a global leader in payments, today announced a new $100 million generative AI ventures initiative to invest in the next generation of companies focused on developing generative AI technologies and applications that will impact the future of commerce and payments. As a pioneer of AI use in payments since 1993, Visa considers this initiative an extension of Visa’s leadership in using AI to drive innovation in payments, create value for partners and clients, and enable and empower global commerce. Generative AI is an emerging subset of AI that is built on Large Language Models (LLMs) to develop artificial general intelligence capable of generating text, images or other content from large sets of existing data when given prompts. “While much of generative AI so far has been focused on tasks and content creation, this technology will soon not only reshape how we live and work, but it will also meaningfully change commerce in ways we need to understand,” said Jack Forestell,
MSCI Completes Acquisition of Burgiss2.10.2023 23:05:00 EEST | Press release
MSCI Inc. (NYSE: MSCI), a leading provider of mission-critical decision support tools and services for the global investment community, today announced that it has completed its acquisition of The Burgiss Group, LLC (“Burgiss”), a market-leading provider of data, analytics, and technology solutions for investors in private assets. The acquisition was originally announced on August 14, 2023. Henry Fernandez, Chairman and Chief Executive Officer, MSCI, said: “We are thrilled to complete this acquisition. By making Burgiss part of our integrated franchise, MSCI will dramatically expand and strengthen our solutions across client segments. In the process, we will help promote greater transparency for investors in private assets." About MSCI Inc. MSCI is a leading provider of critical decision support tools and services for the global investment community. With over 50 years of expertise in research, data, and technology, we power better investment decisions by enabling clients to understand
Carbios Unveils Major Innovation in Polyester Recycling With New Textile Preparation Line, in the Presence of Roland Lescure, French Minister of Industry2.10.2023 19:00:00 EEST | Press release
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231002227008/en/ Roland Lescure, French Minister of Industry (left) accompanied by Emmanuel Ladent, CEO Carbios (far right) and representatives of Carbios partner brands (On, Salomon and Puma), inaugurates the textile preparation line for biorecycling. (Photo: Carbios) Carbios, (Euronext Growth Paris: ALCRB), a pioneer in the development and industrialization of biological technologies to reinvent the life cycle of plastic and textiles, today inaugurated its textile preparation line at its demonstration plant in Clermont-Ferrand, in the presence of Mr. Lescure, French Minister for Industry. To streamline the textile preparation phase, which is currently carried out by hand or on several lines, Carbios has developed a fully integrated and automated line that transforms textile waste from used garments or cutting scraps into raw material suitable for depolymerizat
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom