Wenzhou Medical University

FDA Grants Orphan Drug Designation to China-Developed ApDC for Uveal Melanoma

5 months ago

• An Aptamer Drug Conjugate (ApDC) developed by Chinese researchers has received orphan drug designation from the FDA for uveal melanoma treatment. • The ApDC, developed by Hangzhou Institute of Medicine and Wenzhou Medical University, targets malignant uveal melanoma and liver metastatic tumors with improved safety. • Preclinical studies demonstrate the ApDC's efficacy in inhibiting ocular tumor growth and reducing metastasis to vital organs like the liver and lungs. • Clinical trials are planned to expedite the drug's application, offering new hope for uveal melanoma patients with limited treatment options.

LNZ100 Demonstrates Positive Phase 3 Results for Presbyopia Treatment in China

7 months ago

• LNZ100 (1.75% aceclidine HCl) met the primary endpoint in a Phase 3 trial, showing significant improvement in near vision for Chinese patients with presbyopia. • The study demonstrated rapid onset, with a significant percentage of patients achieving 2-3 lines of improvement in visual acuity within 30 minutes of instillation. • LNZ100 exhibited a long duration of effect, with a notable proportion of patients maintaining improved near vision up to 10 hours post-treatment. • The treatment was well-tolerated, with no serious treatment-related adverse events, suggesting a favorable safety profile for presbyopia management.

Lenz Therapeutics' LNZ100 Demonstrates Positive Phase 3 Results in China for Presbyopia

7 months ago

• LNZ100 (1.75% aceclidine HCl) met the primary endpoint in a Phase 3 trial in China, showing significant improvement in near vision for presbyopic patients. • The study demonstrated rapid onset, with a significant percentage of patients achieving 2-3 lines of improvement within 30 minutes, and sustained effects up to 10 hours. • LNZ100 was well-tolerated, with no serious treatment-related adverse events, indicating a favorable safety profile for the presbyopia treatment. • These results, combined with previous studies, support LNZ100's potential as a global therapy, especially for the estimated 400 million people with presbyopia in China.

Lenz Therapeutics' LNZ100 Demonstrates Positive Phase 3 Results in China for Presbyopia

7 months ago

• Lenz Therapeutics and CORXEL announced positive topline data from a China Phase 3 trial of LNZ100, an aceclidine-based eye drop, for presbyopia treatment. • The trial met its primary endpoint, with 74% of participants achieving a three-line or greater improvement in near vision at 3 hours post-treatment. • LNZ100 showed rapid onset, with 69% effectiveness at 30 minutes, and was well-tolerated with no serious treatment-related adverse events reported. • The FDA has accepted the New Drug Application for LNZ100 in the United States, potentially paving the way for commercialization in major markets.