By Fineline Cube 
Zhaoke Ophthalmology (HKG: 6622) announced that its UK partner Tenpoint Therapeutics has received FDA clearance to market carbachol and brimonidine tartrate ophthalmic solution (2.75%/0.1%) under the trade name Yuvezzi in the US. The preservative‑free, once‑daily miotic eye drop, known clinically as BRIMOCHOL PF, is indicated for improving near vision in adults with presbyopia.
Product & Regulatory Details
| Item | Detail |
|---|---|
| Company | Zhaoke Ophthalmology (6622.HK) |
| Partner | Tenpoint Therapeutics, Ltd. (UK) |
| Product | Carbachol and brimonidine tartrate ophthalmic solution (2.75%/0.1%) |
| Trade Name | Yuvezzi |
| Clinical Name | BRIMOCHOL PF |
| Formulation | Preservative‑free, once‑daily miotic eye drop |
| FDA Clearance | Based on BRIO series Phase III studies |
| Indication | Improving near vision (presbyopia) |
Clinical Efficacy & Safety
| Endpoint | Result |
|---|---|
| Primary: Near Vision Improvement | Statistically significant improvement of ≥3 lines in Binocular Uncorrected Near Visual Acuity (BUCNVA) |
| Distance Vision Preservation | No decline of ≥1 line in Binocular Uncorrected Distance Visual Acuity (BUCDVA) |
| Safety Database | >72,000 treatment days monitored in BRIO II study |
| Serious Adverse Events | Zero treatment‑related SAEs observed |
| Tolerability | Good overall tolerability profile |
Market Impact & Strategic Context
- Presbyopia Market: Affects ~120 million adults in the US; global market projected to exceed $8 billion :by 2030
- Competitive Advantage: Yuvezzi is the first once‑daily, preservative‑free miotic approved for presbyopia, offering convenience over twice‑daily competitors
- Strategic Value: Validates Zhaoke’s partnership model and positions the company for revenue sharing from US commercialization
- Next Steps: Tenpoint to launch Yuvezzi in Q2 2026; Zhaoke eligible for milestone payments and tiered royalties on ex‑China sales
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, revenue projections, and market adoption for Yuvezzi. Actual results may differ due to commercial execution, competitive dynamics, and reimbursement decisions.-Fineline Info & Tech