CyclASol filed with FDA and accepted for dry eye disease
Novaliq announced that the 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.
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. Novaliq further plans to submit a marketing authorization application to the European Medicines Agency and further authorities in 2023.
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