Zhaoke Ophthalmology-B (06622): Self-developed innovative drug Jingyouling® (cyclosporine eye gel) obtained marketing approval from the China Drug Administration

Zhitong Finance App News, Zhaoke Ophthalmology-B (06622) issued an announcement. Based on COSMO's phase III clinical study, the innovative drug Jingyuling® (ciclosporin eye gel) independently developed by the company was approved for marketing by the China Drug Administration (China Drug Administration) on November 10, 2026. The indication is to promote tear secretion in patients with dry eyes. It is suitable for patients with reduced tear production due to dry eyes to improve their ocular signs.

Cyclosporine eye gel only needs to be taken once a day before bedtime to avoid eye discomfort and inconvenience caused by daytime medication. Furthermore, clinical efficacy can be observed as soon as two weeks after starting treatment. With the two major advantages of once-daily administration and rapid effect, ciclosporin ophthalmic gel can be expected to significantly improve patient adherence to medication and improve quality of life.

The phase III clinical study COSMO was a multicenter, randomized, double-blind, solvent-based controlled study that enrolled 644 patients with moderate to severe dry eye. Participants were randomly assigned to receive ciclosporin as an ophthalmic gel or solvent, and administered once a day before bedtime. Follow-up assessments were conducted on day 14, day 42 and day 84, respectively.

On day 84, the lower corneal staining score (ICSS) of 73.7% of patients in the ciclosporin ophthalmic gel group improved by at least 1 point compared to baseline, while the solvent control group was 53.2%, showing that the difference was statistically significant (P<0.0001), reaching the end point of the main study. Notably, significant treatment differences (P<0.05) were observed as early as the 14th day, indicating that the efficacy of ciclosporin ophthalmic gel can be observed within 2 weeks of starting treatment.

Since day 14, compared with the solvent control group, patients treated with cyclosporine ophthalmic gel showed significant statistical improvements in the following measurement indicators: average change in lower corneal staining score (ICSS) from baseline, average change in Oxford scale score for corneal and conjunctival staining compared to baseline, and average change in tear secretion measured by surface anesthesia Schirmer tear test compared to baseline. The benefits of these treatments continued until day 84 (all P<0.05).

During the study period, the incidence of treatment-related adverse ocular events in the ciclosporin ophthalmic gel group was 12.5%, compared with 5.4% in the solvent control group. The most commonly reported adverse reaction in the ciclosporin ophthalmic gel group was eye pain (8.1%), and the incidence of all other adverse effects was less than 3%. There were no reports of serious drug-related adverse events during the study period. Overall, ciclosporin ophthalmic gels showed good safety and tolerability.