Zhaoke Ophthalmology Limited (Ltd) has received FDA clearance for its investigational new drug (IND) application on a cyclosporine (CsA) ophthalmic gel to treat dry eye disease (DED).
First, a rundown on this company.
Headquartered in China, the ophthalmic pharmaceutical company was founded in 2017 with a focus on the research, development, manufacturing, and commercialization of therapies targeting significant unmet needs.
Fast forward to today: Via strategic partnerships with both domestic and international pharma companies, Zhaoke Ophthalmology features a drug portfolio of “innovative and generic” drugs targeting six major ocular diseases:
- DED
- Diabetic macular edema (DME)
- Glaucoma
- Myopia
- Presbyopia
- Wet age-related macular degeneration (AMD)
Now explain CsA.
As an anti-inflammatory therapeutic, topical CsA is routinely used as a first- or second-line therapy for ocular surface disease (OSD).
- In the case of ocular inflammation, systemic CsA may be utilized in combination with other immunosuppressive agents.
How it works: CsA inhibits the activity of certain immune cells (such as T-cells) and reduces inflammatory substance production—leading to reduced inflammation and swelling in the eye and, as a result, increased tear production.
And its use in the United States?
The first FDA-approved therapy for DED was Allergan, Inc’s Restasis (cyclosporine ophthalmic emulsion) 0.05% in 2003.
This was followed by Cequa (cyclosporine ophthalmic solution) 0.09% from Sun Pharmaceutical Industries’ Sun Ophthalmics in 2018 and then Novaliq’s (now Harrow) VEVYE (cyclosporine ophthalmic solution) 0.1% in 2023.
- Check out our coverage on VEVYE’s approval and January 2024 commercial launch.
Alrighty, now to Zhaoke’s CsA ophthalmic gel.
Referred to as one of the company’s “core products,” this gel is intended for the treatment of moderate-to-severe DED.
What it is: A proprietary hydrogel whose novel formulation is designed to enhance the "pharmacokinetic profiles and exposure of CsA on the ocular surface,” enabling CsA to have more time to take effect on DED.
Any clinical research on it so far?
Yes! The ophthalmic gel was previously evaluated in the pivotal phase 3 COSMO study.
- The setup: Over 640 patients were randomized 1:1 to receive nightly treatment with either CsA 0.05% or a placebo for 84 days.
- Evaluations: Corneal and conjunctival staining; Schirmer test; tear breakup time (TBUT)
- Subjective measures: Eye Dryness Score and other dry eye symptoms (using a visual analog scale (VSA)
- The outcome measures:
- Primary: Patients with a ≥1-point decrease in inferior corneal fluorescein staining score (ICSS) from baseline on day 84.
- Secondary: See here.
And those findings?
The study met its primary efficacy endpoint, with 73.7% of patients in the CsA treatment group (versus 53.2% in the vehicle group) achieving a ≥1-point decrease in ICSS.
And in general: CsA 0.05% was found to significantly reduce corneal and conjunctival staining as well as improve tear secretion (versus vehicle) in moderate-to-severe DED.
Nice! Any more recent developments?
Zhaoke announced in April 2025 that patient enrollment had begun for a China-based phase 3 clinical trial on the ophthalmic gel.
- The multicenter, randomized, double-blind, and placebo-controlled study is evaluating CsA 0.05% for its efficacy and safety among 350 moderate-to-severe dry eye patients.
Gotcha. So what’s the plan moving forward?
Thanks to this IND clearance, the company can progress to initiating a multicenter, randomized, double-masked, active-controlled phase 3 trial.
The intent: To use clinical findings from the already-completed COSMO phase 3 trial and the aforementioned China-based phase 3 trial in CsA ophthalmic gel’s “U.S. development plan.”