Novaliq submitted a new drug application to the FDA for CyclASol, a cyclosporine ophthalmic solution for the treatment of dry eye disease signs and symptoms, according to a company press release.
The submission is supported by positive safety and efficacy results in more than 1,000 participants in a phase 2 dose-finding study, the phase 2b/3 ESSENCE-1 study, the phase 3 ESSENCE-2 study and an open-label extension study.
The topical solution demonstrated a fast therapeutic effect, clinically meaningful improvement of ocular surface damage and positive tolerability in ESSENCE-1 and ESSENCE-2,