Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced positive Phase 2 results evaluating CyclASol®, a clear, preservative-free cyclosporine A solution, in 207 patients with moderate to severe dry eye disease (DED). CyclASol showed a consistent reduction in corneal fluorescein staining, the primary sign endpoint, with an early onset of action over the 4-month treatment period.
This Phase 2 randomized, double-masked, vehicle-controlled, multi-center U.S. study consisted of four treatment groups, including two CyclASol groups (0.05% and 0.1%), an open label active control, and a placebo (vehicle control) group. Both CyclASol groups showed a significant improvement in corneal staining compared with the vehicle over the 4-month treatment period. In particular, the central area of the cornea seems to benefit most, which is an important aspect for the visual function in dry eye patients. All treatment groups demonstrated improvement in symptoms, with CyclASol showing improvements over vehicle in subgroups. Data further indicates an early onset of action by reduction in corneal and conjunctival staining in as little as 14 days.
“These Phase 2 results are very promising and verify the preclinical data, in particular regarding an improvement in corneal staining and the tendency to an earlier onset of action,” said Michael E. Stern, Ph.D. and scientific advisory board member for Novaliq. “The role of cyclosporine A in resolving ocular surface inflammation has been well demonstrated and the novel CyclASol formulation may provide a promising new option for physicians and their patients suffering from moderate to severe dry eye disease.”
Both CyclASol concentrations showed excellent safety, tolerability and comfort profile with 98% of the enrolled patients completing the treatment period. No serious adverse events (SAEs) related to CyclASol were reported.
“Consistent improvements in several measures of ocular inflammation of dry eye disease, particularly the improvement in central corneal staining, is a very important feature of the formulation because it positively influences visual function. This, combined with the early onset of action and an excellent tolerability profile, represents a highly relevant improvement over currently available therapies,” said Claus Cursiefen, MD, PhD, FEBO, chairman and professor, Department of Ophthalmology, University of Cologne, and member of Novaliq’s scientific advisory board.
“We are excited as these positive results further validate the potential of our EyeSol® drug delivery platform,“ said Christian Roesky, PhD and chief executive officer Novaliq. “There is a high medical need for innovative, effective, fast-acting and safe treatment options for patients with dry eye disease. These encouraging results will guide our further clinical development in this important disease.”