{"id":55921,"date":"2026-01-30T14:01:56","date_gmt":"2026-01-30T06:01:56","guid":{"rendered":"https:\/\/flcube.com\/?p=55921"},"modified":"2026-01-30T14:01:57","modified_gmt":"2026-01-30T06:01:57","slug":"zhaoke-ophthalmologys-yuvezzi-gets-fda-nod-for-presbyopia","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=55921","title":{"rendered":"Zhaoke Ophthalmology’s Yuvezzi Gets FDA Nod for Presbyopia"},"content":{"rendered":"\n

Zhaoke Ophthalmology<\/strong> (HKG: 6622<\/a>) announced that its UK partner Tenpoint Therapeutics<\/strong> has received FDA clearance<\/strong> to market carbachol and brimonidine tartrate ophthalmic solution (2.75%\/0.1%)<\/strong> under the trade name Yuvezzi<\/strong> in the US. The preservative\u2011free, once\u2011daily miotic eye drop, known clinically as BRIMOCHOL PF<\/strong>, is indicated for improving near vision in adults with presbyopia.<\/p>\n\n\n\n

Product & Regulatory Details<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Zhaoke Ophthalmology (6622.HK)<\/td><\/tr>
Partner<\/strong><\/td>Tenpoint Therapeutics, Ltd. (UK)<\/td><\/tr>
Product<\/strong><\/td>Carbachol and brimonidine tartrate ophthalmic solution (2.75%\/0.1%)<\/td><\/tr>
Trade Name<\/strong><\/td>Yuvezzi<\/td><\/tr>
Clinical Name<\/strong><\/td>BRIMOCHOL PF<\/td><\/tr>
Formulation<\/strong><\/td>Preservative\u2011free, once\u2011daily miotic eye drop<\/td><\/tr>
FDA Clearance<\/strong><\/td>Based on BRIO series Phase\u202fIII studies<\/td><\/tr>
Indication<\/strong><\/td>Improving near vision (presbyopia)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Efficacy & Safety<\/h2>\n\n\n\n
Endpoint<\/th>Result<\/th><\/tr><\/thead>
Primary: Near Vision Improvement<\/strong><\/td>Statistically significant improvement of \u22653 lines<\/strong> in Binocular Uncorrected Near Visual Acuity (BUCNVA)<\/td><\/tr>
Distance Vision Preservation<\/strong><\/td>No decline of \u22651 line<\/strong> in Binocular Uncorrected Distance Visual Acuity (BUCDVA)<\/td><\/tr>
Safety Database<\/strong><\/td>>72,000 treatment days<\/strong> monitored in BRIO\u202fII study<\/td><\/tr>
Serious Adverse Events<\/strong><\/td>Zero treatment\u2011related SAEs<\/strong> observed<\/td><\/tr>
Tolerability<\/strong><\/td>Good overall tolerability profile<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Impact & Strategic Context<\/h2>\n\n\n\n