CyclASol® is the first water-free topical anti-inflammatory and immunomodulating ophthalmic solution, containing 0.1% cyclosporine. The water-insoluble active pharmaceutical ingredient cyclosporine is solubilized in the novel excipient perfluorobutylpentane. CyclASol® is preservative-free and does not contain any oils or surfactants, which can be irritating and disturbing for the tear film. 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.
The two paper presentations include results from the 12-month ESSENCE-2 open label extension study and the pooled analysis of ESSENCE-1 and ESSENCE-2, the two pivotal studies, looking into subgroups with and without cataract.
Long-Term Safety and Efficacy of a Water-Free Cyclosporine Ophthalmic Solution for the Treatment of Dry-Eye Disease: Essence-2-OLE Study
ASCRS Paper ID 89620
Session title: Ocular Surface Disease II
Presentation date: Sunday, May 7, 2023
Session time: 8:00 AM-9:30 AM
Presenter: David Wirta, MD
“The long-term data confirm the excellent safety and tolerability profile of CyclASol®,” said David Wirta, MD, investigator and presenter for the study. “Notably, all studied dry eye symptom scores showed a constant reduction reaching a minimum after 1 year of treatment combined with high patient satisfaction rates. If approved this treatment will address important patient needs”.
Efficiency of a water-free topical cyclosporine in the treatment of dry eye disease (DED) in patients with or without cataract
ASCRS Paper ID 94201
Session title: Ocular Surface Disease III
Presentation date: Sunday, May 7, 2023
Session time: 10:00 AM-11:30 AM
Presenter: Esen Akpek, MD
“We are excited to present new results of our CyclASol® program,” said Dr. Christian Roesky, CEO Novaliq. “Dry eye is a very common ocular surface disease and has also an influence on patient satisfaction after LASIK or cataract surgery. The rapid and clinically meaningful improvements on the ocular surface in patients with dry eye disease and concomitant cataract make CyclASol a promising new option to maximize postsurgical outcomes and patient satisfaction. We hope that we can bring this innovation to patients soon.”
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 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.
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