CyclASol 0.1% for dry eye disease
showed superiority to vehicle in change from baseline on corneal fluorescein staining in its first pivotal clinical trial, Novaliq announced in a press release.
The phase 2b/3 randomized, double-masked, vehicle-controlled ESSENCE trial included 328 patients at nine U.S. clinical sites and evaluated the primary efficacy endpoint of improvement in total corneal fluorescein staining over vehicle at 4 weeks, with continued dosing over 3 months.
Improvement of total corneal fluorescein staining at day 29 was statistically significant with CyclASol over vehicle (P = .0002), with effects beginning as early as 2 weeks after treatment, the release said.
CyclASol 0.1% is a preservative-free ophthalmic solution of 0.1% cyclosporine A in EyeSol, Novaliq’s water-free technology for ophthalmology.
“These results provide pivotal evidence and a clear direction for Novaliq to pursue a timely completion of the clinical development of CyclASol,” Gabriela Burian, MD,consulting chief medical officer for Novaliq, said in the release.