Fast and powerful anti-inflammatory dry eye drug therapy
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.
An early onset of action, clinical significant efficacy on signs and symptoms and excellent comfort, as shown in the recent Phase 2/3 clinical ESSENCE-1 trial, differentiates CyclASol® from existing therapies.
Results from the long-term extension study ESSENCE-2 OLE confirmed that the effect of CyclASol was maintained, and even improved for most endpoints, over the 52-week treatment period.
Today anti-inflammatory therapeutic options are standard for care in DED. Inflammation is the key underlying driver of the disease as chronic immunologic processes have a pivotal role in the pathology of dry eye. The chronic inflammatory nature of DED also causes progressive corneal surface damage. Corneal surface damage can negatively affect visual function and any refractory eye care outcome in particular in cataract or refractive patients where dry eye is common.
Despite several anti-inflammatory therapeutic options approved, there is a large unmet need for a therapy that can rapidly and reliably repair corneal surface damage secondary to DED. Also better comfort is a high unmet need.
Regulatory status of CyclASol®
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 ongoing phase 3 study in China started in March 2021.