HEIDELBERG, Germany, and CAMBRIDGE, MA, USA– Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).
The Agency completed the filing review of the CyclASol® NDA and determined that the application is sufficiently complete to permit a substantive review. No potential review issues have been identified at this time. The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA for announcing its decision on Novaliq’s NDA after reviewing the application is June 8, 2023.
“This is an exciting time for ophthalmologists and optometrists and their patients as we are one step closer to address important needs and to better treat a serious ocular surface condition affecting millions of Americans”, said Christian Roesky, Ph.D., CEO, Novaliq. “If approved, CyclASol® would be a highly potent but comfortable anti-inflammatory therapy for patients with dry eye disease. It shows impressive and rapid therapeutic effects objectively measured on the ocular surface in the majority of patients, with clinical benefits on the signs and symptoms of the disease.”
CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in afflicted patients in this indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints.
“This important milestone marks the second NDA acceptance of water-free dry eye therapies in less than 3 months.1 The two distinct modalities of action of the EyeSol®-based dry eye therapies open new and complimentary clinical prospects on how to treat DED in the future,” said Sonja Krösser, Ph.D., Vice President Preclinical & Clinical Development at Novaliq. “We are committed to work closely with the FDA to bring this novel cyclosporine drug product to patients suffering from DED as quickly as possible.”
Dry eye is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.2,3 Inflammation and immunologic processes play a key role in the pathology of the disease.
Novaliq further plans to submit a marketing authorization application to the European Medicines Agency and further authorities in 2023.
