regulatory
confidence high
sentiment positive
materiality 0.85
FDA approves Clearside's XIPERE for macular edema associated with uveitis; first suprachoroidal therapy
Clearside Biomedical, Inc.
- XIPERE (triamcinolone acetonide injectable suspension) is the first FDA-approved therapy for suprachoroidal injection.
- Phase 3 PEACHTREE trial: 47% of XIPERE patients achieved ≥15-letter BCVA improvement vs 16% sham (p<0.01) at Week 24.
- Bausch + Lomb markets XIPERE; expected availability Q1 2022 under Clearside's SCS Microinjector delivery system.
- This is Clearside's first commercial product and the first approved treatment specifically for macular edema associated with uveitis.