Novaliq announced that it has begun enrolling patients in a phase 2 clinical trial that will evaluate the safety, efficacy, and tolerability of CyclASol for the treatment of moderate to severe dry eye disease. CyclASol is a clear, preservative-free ophthalmic solution of cyclosporine in SFA (semifluorinated alkanes).
This phase 2 study is a randomized, double-masked, placebo-controlled, multicenter trial, designed to evaluate the safety, efficacy, and tolerability of topical CyclASol for the treatment of moderate to severe dry eye disease, according to a company news release. Patients will be randomized to one of four treatment groups that include two CyclASol groups, a placebo (vehicle control) group, and an open label cyclosporine A 0.05% ophthalmic emulsion group. Study subjects will self-administer one drop twice daily, returning for examination periodically and at the end of the trial at 4 months. The study is being conducted in approximately 4 sites in the United States, and total planned enrollment is 200 patients.
“CyclASol is differentiated from other cyclosporine containing treatments for dry eye due to its innovative vehicle,” George Ousler, Vice President of Dry Eye at Ora, said in the news release. “In a murine model of dry eye disease, CyclASol was shown to be at least equally effective but with a significantly faster therapeutic response compared to commercially available cyclosporine and dexamethasone products. Furthermore, the clinical phase 1 data has demonstrated excellent tolerability.”
“The initiation of this phase 2 trial is an important step in advancing our clinical development plan,” Bernhard Günther, managing director and CEO of Novaliq, said in the news release. “In 2015, we made our footprint in the OTC dry eye market with the successful European launch of NovaTears. Given the lack of treatment options currently available for patients with more severe dry eye disease, there is a need for novel, non-blurring, non-irritating, and preservative- and water-free formulations.”