Novaliq today touted topline data from the first pivotal trial of its CyclASol 0.1% drug designed to treat dry eye disease.
The company is hoping to position its 0.1% cyclosporine A product as advantageous compared to other ophthalmic treatments, noting that its EyeSol technology helps boost the drug’s efficacy and provide an earlier onset of effect.
Novaliq’s Essence Phase IIb/III trial enrolled 328 patients at sites across the U.S. and was designed to assess the safety, efficacy and tolerability of topical CyclASol 0.1% in people with aqueous-deficient dry eye disease. The study’s primary efficacy endpoint, improvement of total corneal fluorescein staining, was measured at four weeks and participants continued receiving doses for efficacy and safety considerations over the course of the three months.
The trial met its primary efficacy endpoint with high statistical significant, according to Novaliq. The company reported that, consistent with previously-held studies, the central area of the cornea benefited most from treatment with CyclASol. Novaliq also noted that participants saw the effects of CyclASol as early as two weeks into treatment and that those benefits were maintained throughout the remainder of the trial.
The study also confirmed a strong safety and tolerability profile for the drug, Novaliq said. Detailed results from the company’s Essence trial are slated to be presented by CEO Christian Roesky during the Ophthalmology Innovation Summit in Chicago later this month.
“We are very pleased with the outcomes from Essence. CyclASol 0.1% unfolds the full potential of cyclosporine for the first time in the treatment of DED and demonstrates the superior benefits of our non-aqueous, preservative-free formulation, allowing clinicians to treat more of their patients suffering from DED,” Dr. Gabriela Burian, consulting CMO for Novaliq GmbH, said in prepared remarks. “These results provide pivotal evidence and a clear direction for Novaliq to pursue a timely completion of the clinical development of CyclASol.”