Cyclosporine Eye Drops 0.09% is a nanotechnology-enabled formulation in a clear solution. It uses a unique tiny structure called “micelle” as the vehicle to allow for greater tissue penetration and gentle side effect profiles in a high concentration. The product has been approved for marketing in the U.S., Australia and Canada.
In May 2021, the Group completed the enrollment of all 384 subjects for the phase III bridging trial in China, which only took around 4 months (including the Chinese Spring Festival).
The U.S. FDA approval was based on data from a multi-center, randomized, double-blind, vehicle-controlled phase III confirmatory study conducted on 744 patients with dry eye. After 12 weeks of treatment, as compared to vehicle, Cyclosporine Eye Drops 0.09% showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after the initiating treatment.
The incidence of dry eye in China is 21%-30%, 40% of which are moderate-to-severe patients (about 118-168 million people). Although various symptom alleviating agents such as artificial tears are available in the market, there are few satisfactory options in practice. In addition, in terms of ophthalmic cyclosporine, related treatment options are still limited due to the historic challenge of making an optic formulation of this agent at a suitable concentration without increasing side effects. Cyclosporine Eye Drops 0.09% is expected to meet this clinical need and provide a safe and effective treatment option for patients with dry eye.