The unique water-free investigational drug increases residual time on the ocular surface and enables a high bio-availability in the target tissues to unfold the full potential of cyclosporine A and fast onset of action within 2 weeks.
The multi-dose, preservative-free, smaller and more physiologic drop size profile provides unique clinical benefits and outstanding tolerability.
Improvement in visual function associated with a clinically significant reduction of corneal staining, as shown in the recent Phase 2/3 clinical ESSENCE-1 trial, differentiates CyclASol® from existing therapies.
The CyclASol® development plan and clinical trial design have been agreed upon by the U.S. Food and Drug Administration (FDA) in an end-of-phase 2 meeting. The FDA concurred with the company that the replication of the ESSENCE-1 results on clinical signs and patient reported symptoms is sufficient clinical evidence to support a New Drug Application (NDA) filing in the indication.
The ongoing ESSENCE-2 trial is a multicenter, randomized, double-masked, vehicle-controlled clinical trial to assess efficacy, safety and tolerability of CyclASol® for the treatment of signs and symptoms of dry eye disease.
After approval in the U.S.A. Novaliq intends to seek approval in other geographies including the European Union as well.
In December 2020, Jiangsu Hengrui Medicine (SHA 600276) has received approval from China’s Center for Drug Evaluation of the National Medical Products Administration to carry out clinical studies with CyclASol® for the treatment of dry eye in China.
CyclASol® was exclusively licensed to Hengrui for China in November 2019. The start of the phase 3 study in China is planned for the 1st half of 2021.