Novaliq Plans to File a Markting Authorisation Application for CyclASol® in the E.U. for the Treatment of Dry Eye Disease in July 2023
Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) determined that CyclASol® is eligible to be reviewed in a centralized procedure to receive a Union Marketing Authorisation for the European Economic Area (EEA). In December 2022, EMA stated in its response that, based on the documentation provided by Novaliq, a submission is in the interest of patients at Community level under Article 3(2)b - Interest of patients of Regulation (EC) No 726/2004. Consequently, Novaliq has submitted a letter of intent to EMA to file the MAA in July 2023.
Dry eye is one of the most common ocular surface disorders with approximately 15 million diagnosed patients in the 5 largest European countries1. Treatment options for DED in the European market are limited, with only one approved drug therapy restricted to the treatment of severe keratitis associated with DED1.
CyclASol® consists of cyclosporine solubilized in a novel water-free excipient, perfluorobutylpentane, and is the first available solution developed with the water-insoluble cyclosporine. This water-free drug product does not require preservatives, oils or surfactants, which can be irritating and disturb the tear film. The superior tolerability of CyclASol® has been proven clinically.
“I see many patients in my practice whose lives are impacted by dry eye disease. New approved drug therapies for these patients in Europe are very welcome.” said Christophe Baudouin, MD, PhD, FARVO, Professor of Ophthalmology at Quinze-Vingts National Ophthalmology Hospital and President of the European Dry Eye Society “Having a comfortable product that provides clinically meaningful improvements of the ocular surface as early as 2 weeks is addressing an important medical need and could help to limit steroid use."
CyclASol® has demonstrated in two independent adequate and well-controlled, multicenter studies (ESSENCE-12 and ESSENCE-2) clinically meaningful and statistically significant improvements in moderate to severe patients affected by the disease indication. Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining score favoring CyclASol® as early as on Day 15. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. Patients responding also showed statistically significant improvements in a variety of symptoms compared to non-responders within 4 weeks. CyclASol® has a favorable tolerability profile demonstrating high patient acceptance and an improved side effect profile. Continued improvement under therapy in both, signs and symptoms of DED, has been clinically demonstrated over a period of up to 56 weeks also confirming the favorable tolerability profile.
“CyclASol® was specifically developed as a potent and comfortable anti-inflammatory dry eye drug therapy with rapid onset of effect for dry eye patients not adequately responding to artificial tears”, said Christian Roesky, Ph.D., CEO, Novaliq. “We are excited by the response of the European Medicines Agency and look forward to hopefully bring CyclASol® to patients in Europe, and ultimately address an unmet medical need for those suffering with dry eye disease.”
In the United States the Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date for the CyclASol® New Drug Application (NDA) on June 8, 2023.
About Novaliq
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 technology. EyeSol® is Novaliq’s proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Two EyeSol® dry eye drug products are in regulatory review by U.S. FDA: CyclASol® and NOV03 (perfluorohexyloctane) with PDUFA target action dates on June 8 and 28, 2023 respectively. In the EU perfluorohexyloctane is registered as a medical device to treat patients with dry eye disease since 2013. The company continues to progress into other ophthalmic indications based on its validated EyeSol® platform.
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 www.novaliq.com.
Recommended Readings
- Global Data. Dry Eye Syndrome: Seven-Market Drug Forecast and Market Analysis Update | December 2022
- Sheppard et al. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297
Any product/brand names and/or logos are trademarks of the respective owners.
© 2023 Novaliq GmbH, Heidelberg, Germany.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230208005056/en/
Contact information
Novaliq Media Contact:
Simone Angstmann-Mehr
info@novaliq.com
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
I-care Group Continues Global Expansion with a European Training Arm4.12.2025 16:00:00 EET | Press release
I-care Group, the global leader in predictive maintenance and reliability solutions, announces the launch of Technical Associates of Europe (TAE), a new independent and certifying training organization headquartered in Mons, Belgium. This strategic initiative strengthens I-care’s global development and extends its professional training offerings in maintenance, reliability, lubrication and predictive-maintenance technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204628319/en/ Building on the heritage of Technical Associates of Charlotte (TAC) — a U.S. training organization founded in 1961 and acquired by I-care Group in 2023 —Technical Associates of Europe represents a major expansion of I-care’s training ecosystem. “Technical Associates of Europe marks an important milestone in I-care’s journey,” said Fabrice Brion, CEO of I-care Group. “It reflects both the maturity of our organization and our ambition to cont
MSCI Launches Breakthrough Index Integrating Public Markets and Private Equity4.12.2025 16:00:00 EET | Press release
MSCI Inc. (NYSE: MSCI) launched the MSCI All Country Public + Private Equity Index,an innovative daily index that combines public markets and a broad private equity view within a single, coherent framework. The launch marks a major shift in how investors can assess total equity exposures and measure performance across their portfolio. With private markets increasingly integrated into investment portfolios, private equity is becoming a core component of total portfolio allocation, contributing to diversification, long-term return potential and exposure to segments of the economy not captured by public markets. Reflecting the evolving structure of investor portfolios, this index sets a new standard for tracking global equity performance across public and private markets. The index combines the flagship MSCI ACWI IMI, which represents the performance of the full opportunity set of publicly listed equities across developed and emerging markets and serves as the benchmark for approximately
University of Maryland Launches Innovative Clinician Training Program in Ketogenic Metabolic Therapy for Mental Health4.12.2025 16:00:00 EET | Press release
Baszucki Group today announced a partnership with University of Maryland School of Medicine for an innovative training initiative that will build capacity for delivering ketogenic metabolic therapy in mental health care. The program, titled “LIVE IT~LAUNCH IT: Learning How to Implement and Use a Ketogenic Diet to Improve Mental Health in Your Patients For Health Care Workers” is led by Deanna Kelly, PharmD, BCPP, the Dr. William and Carol Carpenter Professor in Psychiatry for Mental Illness Research and Director of the Maryland Psychiatric Research Center at the University of Maryland School of Medicine. This initiative aims to educate and empower practitioners by guiding them in adopting the intervention themselves. The aim is to prepare a variety of healthcare professionals to safely and confidently incorporate this promising personalized metabolic treatment framework in both clinical and research settings. This press release features multimedia. View the full release here: https://w
Cross-Border Private Credit Set to Surge, But Operational Complexity Threatens Momentum, CSC Finds4.12.2025 15:30:00 EET | Press release
Cross-border private credit transactions are poised for strong growth, yet operational complexity is emerging as a critical hurdle. According to CSC, the leading provider of business administration and compliance solutions, an overwhelming 92% of limited partners (LPs) express concern over the complexity of these deals. Published in CSC’s latest report, Private Credit 2025: Global Strategies for a $1.5 Trillion Market, the findings highlight a growing disconnect between investors and fund managers as private credit continues its rapid international expansion. 1 While both LPs and general partners (GPs) remain optimistic about the growth of cross-border private credit, they diverge sharply when it comes to operational readiness. Nearly eight in 10 GPs (79%) anticipate growth in the sector over the next three years, with more than half (51%) expecting a significant acceleration. LPs, however, are increasingly cautious—40% reported turning down multiple fund or investment opportunities la
Pace selected by Prudential Financial to help automate its insurance operations with agentic AI4.12.2025 15:15:00 EET | Press release
Pace, the agentic workforce for insurance, was chosen by Prudential’s Individual Life Insurance (ILI) business to help simplify and improve its service delivery. Pace’s AI-powered agents are now streamlining policy servicing and supporting quality assurance efforts within Prudential’s ILI business. The first set of automated systems is now live taking on thousands of hours of work. “Our work with Prudential is an example of how AI can be used as a strategic advantage,” said Pace CEO Jamie Cuffe. “We’re thrilled to support their exceptional team with AI agents in production today that deliver best-in-class accuracy and speed at significant scale.” This multi-year agreement between Pace and Prudential’s ILI business began as a pilot and quickly moved to full production after demonstrating clear improvements in speed and operational efficiency. “We’ve taken a step forward on our journey to modernize the customer acquisition process,” said Sara Atkinson, vice president of customer acquisit
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