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HEIDELBERG, Germany and CAMBRIDGE, Mass.
In two pivotal studies, CyclASol® demonstrated rapid onset of therapeutic effect, clinically meaningful improvement in ocular surface damage and excellent tolerability in the indication
Dr.
Dry eye is one of the most common ocular surface diseases, with approximately 18 million Americans diagnosed with DED
Ocular surface damage secondary to DED may also affect refractive measurements prior to corneal refractive surgery and ultrasound refractive surgery and adversely affect expected visual outcomes after these procedures
"We are honored to see another product quickly enter the market, marking another important turning point and milestone in Novaliq's growth trajectory
About CyclASol®
CyclASol® is a first-in-class topical therapy with cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug
The NDA is supported by safety and efficacy results in more than 1,000 DED patients from the Phase 2 dose-finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study, and the open-label extension study
In two independent adequate and well-controlled multicenter studies (ESSENCE-1 and ESSENCE-2), CyclASol® demonstrated clinically meaningful and statistically significant improvements across indications
Effects on the ocular surface included a statistically significant reduction in total corneal fluorescein staining (tCFS) score, favouring CyclASol® in both studies on days 15 and 29
Effects on tear production: In both studies, a statistically significantly higher proportion (p<0.
Head-to-head data compared with Restasis™ from the Phase 2 study showed that CyclASol® had a stronger and faster treatment effect on the ocular surface
Efficacy Maintenance Results from the long-term CYS-005 study confirmed that the efficacy of CyclASol® was maintained over the 52-week treatment period and even improved on most endpoints
Safety and Tolerability: Tolerability of CyclASol® was shown in both studies by high eye drop comfort patient scores
Source: Novaliq GmbH
