Consult on Unexpected Preclinical Finding

Case Study:
The Challenge

Development program status:
Phase 1 clinical trial complete and planning for Phase 2

Unexpected chronic safety finding:
"Corneal Opacity"


  • Is finding drug-releated?
  • What is relevance to patients?
  • What are the regulatory implications?
  • How best conduct Phase 2 surveillance?
The Solution

Our Team

  • Basic Scientists (cornea)
  • Regulatory Toxicologists
  • DVM and MD Ophthalmologists
  • MD Clinical Trialist

Our Work

  • 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

Our Advice

  • Include additional characterization of finding in ongoing preclinical safety study
  • Approach to Phase 2 clinical surveillance and protocol design
The Outcome

"Thanks for sending the summary in a timely manner. This is very helpful." ...and... "Once again a special thanks to the whole OSOD Team for the very productive discussion.

Phase 2 Ongoing