Novaliq initiates patient randomization in CyclASol phase 3 trial
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Novaliq has started the randomization of patients in ESSENCE-2, a phase 3 clinical trial of CyclASol, a topical anti-inflammatory and immunomodulating ophthalmic solution for the treatment of dry eye disease, according to a press release.
CyclASol (cyclosporine A 0.1% in EyeSol) is a water-free formulation with early-onset efficacy and improved tolerability in patients with dry eye disease, the release said. ESSENCE-1, a previous phase 2/3 clinical trial, showed statistically significant improvements in sign and symptom endpoints at 4 weeks.
“If ESSENCE-2 is successful, we will have sufficient clinical evidence to support a new drug application for CyclASol for the treatment of the signs and symptoms of dry eye disease in 2022,” Sonja Krösser, PhD, vice president of clinical development at Novaliq, said in the release.
The multicenter, randomized, double-masked, vehicle-controlled trial, assessing the efficacy, safety and tolerability of CyclASol in dry eye treatment, will include about 834 patients, according to the release. Novaliq anticipates publishing topline data in the second half of 2021.
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