Novaliq submits NDA for CyclASol for the treatment of dry eye disease
August 09, 2022
1 minute read
Novaliq has submitted a new drug application to the FDA for CyclASol, a cyclosporine ophthalmic solution for the treatment of signs and symptoms of dry eye disease, according to a company press release.
The submission is supported by positive safety and efficacy results in over 1,000 participants in a Phase 2 dose-finding study, the Phase 2b/3 ESSENCE-1 study, the phase 3 ESSENCE-2 and an open-label extension study.
The topical solution demonstrated rapid therapeutic effect, clinically significant improvement in ocular surface damage, and positive tolerance in ESSENCE-1 and ESSENCE-2, with effects maintained for 12 months, including improvement in some sign parameters and symptoms, according to the statement. .
Specifically, CyclASol demonstrated clinically significant improvement in total corneal fluorescein staining and a statistically higher percentage of patients with increased Schirmer tear test scores.
“This is the first submission for a new category of waterless topical drug therapy products using EyeSol as the drug carrier,” Christian Roesky, PhD, CEO of Novaliq, said in the statement. “If approved by the FDA, CyclASol addresses significant unmet medical needs in [dry eye disease] by its healing effect on the ocular surface associated with a great comfort of administration.