Novaliq Announces Publication of Second Pivotal Phase 3 Trial Data on CyclASol 0.1% (Cyclosporine Ophthalmic Solution) in JAMA Ophthalmology
Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that results from the second pivotal Phase 3 trial for CyclASol®, ESSENCE-2, have been published in Journal of the American Medical Association (JAMA) Ophthalmology. CyclASol® is currently under regulatory review for the treatment of signs and symptoms of dry eye disease (DED). The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 8, 2023.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230412005078/en/
ESSENCE-2 demonstrated that CyclASol improved total and central corneal staining within 2 weeks (Photo: Business Wire)
The publication titled “Efficacy and Safety of a Water-Free Topical Cyclosporine 0.1% Solution for the Treatment of Moderate to Severe Dry-Eye Disease: ESSENCE-2, a Randomized Clinical Trial” [Protected link] reported that CyclASol® shows early therapeutic effects on the ocular surface. This study evaluated corneal staining responders to get a better understanding of how many patients benefit from the treatment. A ≥ 3 score improvement of corneal staining on the National Eye Institute (NEI) scale is an immediately noticeable and clinically meaningful response of a dry eye disease therapy1. In ESSENCE-2, 71.6% of CyclASol® treated patients showed such a response after 4 weeks of treatment, significantly more than in the vehicle group. Notably, the study showed that a ≥ 3 score of corneal staining improvement was associated with significant improvements in a variety of patient reported symptoms, establishing a correlation between the magnitude of improvement in the physician-measured clinical signs and the patient-reported symptoms.
According to Dr. Esen Akpek, MD, professor of ophthalmology at the Wilmer Eye Institute of Johns Hopkins hospital, Baltimore, MA and primary author of the publication, corneal staining represents the single most critical clinical parameter for DED due to its direct and indirect impact on vision. As reported, the rapidity of the onset as well as the magnitude of effect of CyclASol® 0.1%, twice-daily eye drop solution, on corneal staining has not been shown with any of the currently used therapies. The profile combined with demonstrated tolerability may provide distinct clinical benefit to patients and eye care professionals alike when the product is approved.
CyclASol® consists of the water-insoluble active pharmaceutical ingredient cyclosporine solubilized in a novel, water-free excipient, perfluorobutylpentane. This makes CyclASol® the first water-free drug solution without requirement to use any preservatives, oils, or surfactants, which can be irritating and disturbing for the tear film.
“High quality clinical research and scientific communications of the results are key strengths at Novaliq,” said Dr. Christian Roesky, CEO Novaliq. “The breadth and depth of the scientific publications on CyclASol® in peer-reviewed journals provides increasing evidence on the clinical value of our water-free technology to address unmet patient and medical needs”.
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 reviews 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.
- Holland EJ, Jackson MA, Donnenfeld E, et al. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208
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/20230412005078/en/
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
ReNew Announces Results for the Fourth Quarter (Q4 FY23) and Fiscal 2023, both ended March 31, 20237.6.2023 00:00:00 EEST | Press release
ReNew Energy Global Plc (“ReNew” or “the Company”) (Nasdaq: RNW, RNWWW), a leading decarbonization solutions company, today announced its consolidated IFRS results for Q4 FY23 and the fiscal year ended March 31, 2023. Operating Highlights: As of March 31, 2023, the Company’s portfolio consisted of 13.7 GWs, a 28.2% increase year on year, of which ~ 8.0 GWs are commissioned and 5.7 GWs are committed. 101 MW of Purchase Power Agreements (“PPAs”) were signed in the fourth fiscal quarter of 2023 and only ~1% of our total portfolio have Letters of Award that await a PPA. Total Income (or total revenue) for Q4 FY23 was INR 25,916 million (US$ 315 million), an increase of 47.1% over Q4 FY22. Adjusted EBITDA(2) for Q4 FY23 was INR 12,010 million (US$ 146 million), as against INR 12,787 million (US$ 156 million) in Q4 FY22. Net profit for Q4 FY23 was INR 74 million (US$ 1 million) compared to a net loss of INR 3,554 million (US$ 43 million) for Q4 FY22. Cash Flow to equity(2)(“CFe”) for Q4 was
Kenvue to Announce Second Quarter 2023 Results on July 20, 20236.6.2023 23:30:00 EEST | Press release
Kenvue Inc. (NYSE: KVUE) (“Kenvue”), the world’s largest pure-play consumer health company by revenue, today announced that its financial results for the second quarter ending July 2, 2023, will be released before market open on July 20, 2023. The company will host a conference call and webcast at 7:30 a.m. Eastern Time to report its second quarter results. The conference call can be accessed by dialing 877-407-8835 from the U.S. or 201-689-8779 from international locations. A live webcast of the conference call will be available at https://investors.kenvue.com. A replay will be available approximately two hours after the live event. About Kenvue Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, our iconic brands—including AVEENO®, BAND-AID® Brand Adhesive Bandages, JOHNSON’S®, LISTERINE®, NEUTROGENA®, TYLENOL® and ZYRTEC® — are recommended by health care professionals and can be truste
Bentley Systems Announces Allen Li has Joined as General Manager, China6.6.2023 23:01:00 EEST | Press release
Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced that Allen Li has been appointed to the new role of General Manager, China, reporting to Chief Revenue Officer Brock Ballard. Allen Li has had a long executive career at enterprise software leader SAP, including as Chief Operating Officer, China. He earned a bachelor’s degree in Engineering and a master’s in Technology Management at Harbin Institute of Technology, and then an Executive MBA from University of Mannheim Business School. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230606006011/en/ Allen Li has been appointed to the new role of General Manager, China. Image courtesy of Bentley Systems. While Bentley’s infrastructure engineering offerings have become well established in major design institutes and owner organizations, the company is also pursuing substantial growth opportunities as a platform for softwa
Kalray Announces Production Launch of New "Coolidge™2" DPU Processor Optimized for AI and Intensive Data Processing6.6.2023 18:46:00 EEST | Press release
Kalray (Euronext Growth Paris: ALKAL), a leading provider of hardware and software technologies and solutions for high-performance, data-centric computing markets from cloud to edge today announces the tape-out1 of Coolidge™2, a new version of its 3rd generation Coolidge™ DPU processor. Based on Kalray’s patented MPPA® (Massively Parallel Processor Array) architecture, the Coolidge™2 processor has been designed to deliver ever-higher performance in the processing of artificial intelligence (AI) and data in general. Thanks to Coolidge™2, Kalray intends to accelerate its growth, particularly in edge computing and data- intensive storage workloads. COOLIDGE™2, AN ULTRA-HIGH-PERFORMANCE DPU PROCESSOR FOR AI At a time when AI development is progressing rapidly, mastering this technology is a major challenge, both in terms of managing algorithms and in processing the massive quantities of data generated and stored by AI workloads. Processors are at the forefront of the solution. “We are very
BDA Promotes Bermuda’s FinTech Sector at Money20/20 Europe6.6.2023 17:47:00 EEST | Press release
The Bermuda Business Development Agency (BDA) will promote Bermuda’s burgeoning Financial Technology (FinTech) sector at the Money20/20 Europe conference. Money20/20 Europe focusses primarily on the future of payments and financial services and is being held this year in Amsterdam, Netherlands from June 6–8. David Hart, CEO, BDA said, “The BDA’s presence at Money20/20 Europe follows our participation at Consensus in Austin, Texas in April, where we experienced an outpouring of interest from potential new digital asset businesses. While Bermuda currently has 21 digital asset business licences on the register, we anticipate continued growth in our tech ecosystem. It is important to continue to promote Bermuda’s legal and regulatory certainty regarding FinTech regulation and supervision, so we are inviting everyone we are meeting with here to register for our fifth annual Bermuda Tech Summit, being held this year from October 9–10 at the Hamilton Princess & Beach Club.” In terms of promot
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