regulatory
confidence high
sentiment positive
materiality 0.75
Kiora Pharmaceuticals Receives IND Approval for Phase 2 Study of KIO-101 for Ocular Autoimmune Disease
KIORA PHARMACEUTICALS INC
- Kiora received IND approval from FDA for Phase 2 study of KIO-101 for ocular surface disease in autoimmune patients.
- Phase 2 trial will enroll ~120 patients in a multi-center, randomized, double-masked, controlled study assessing safety and efficacy.
- Study expected to begin enrolling patients in Australia in first half of 2023; two concentrations (0.15% and 0.30%) will be tested.
- KIO-101 is a topical DHODH inhibitor; systemic DHODH inhibitors generate ~$2B annually; target market ~3.43M U.S. patients.