Novaliq submits NDA for CyclASol for treatment of dry eye disease
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, with the effects maintained through 12 months, including an improvement in some sign and symptom endpoints, according to the release.
Specifically, CyclASol demonstrated a clinically meaningful improvement in total corneal fluorescein staining and a statistically significant higher percentage of patients with increases in Schirmer’s tear test scores.
“This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol as a drug carrier,” Christian Roesky, PhD, CEO of Novaliq, said in the release. “If approved by the FDA, CyclASol addresses important unmet medical needs in [dry eye disease] through its ocular surface healing effect combined with high comfort of administration.”
Read more about