Novaliq Plans to File a Marketing Authorization Application for CyclASol in the EU for Dry Eye Disease
Novaliq announced its plans for filing a marketing authorization application (MAA) 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 Authorization for the European Economic Area (EEA). Novaliq has submitted a letter of intent to EMA to file the MAA in July 2023.
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.
CyclASol has demonstrated in two independent 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 4 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,” Christian Roesky, PhD, CEO, Novaliq, said in a company news release. “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 FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for the CyclASol new drug application (NDA) on June 8, 2023.