HEIDELBERG, Germany--(BUSINESS WIRE)--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.
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