Development program status:
Phase 1 clinical trial complete and planning for Phase 2
Unexpected chronic safety finding:
- Is finding drug-releated?
- What is relevance to patients?
- What are the regulatory implications?
- How best conduct Phase 2 surveillance?
- Basic Scientists (cornea)
- Regulatory Toxicologists
- DVM and MD Ophthalmologists
- MD Clinical Trialist
- Review the literature/study data and corneal images
- Network with MD and DVM ophthalmologists from OSOD, the animal supplier and ACVO to clarify etiology and relevance of finding.
- Partner with clinical planning and regulatory meeting
- Include additional characterization of finding in ongoing preclinical safety study
- Approach to Phase 2 clinical surveillance and protocol design