Ocular Therapeutix Q2 2025: Unpacking Key Contradictions in SOL-R Trial Criteria and FDA Relations

Rescue criteria for SOL-R, FDA involvement in rescue criteria changes, purpose of redosing in SOL-1, rescue criteria for SOL-R trial, and FDA discussions and regulatory path are the key contradictions discussed in Ocular Therapeutix's latest 2025Q2 earnings call.



Clinical Trial Advancements:
- Ocular Therapeutix reported exceptional retention and conduct in both the SOL-1 and SOL-R trials, with over 344 patients randomized in SOL-1 and a 6-month screening and loading phase completed in SOL-R.
- The strong retention and trial integrity were attributed to robust site selection, investigator commitment, and rigorous operational planning.

Rescue Criteria and Trial Strategy:
- The rescue criteria in SOL-R were modified to a greater than 5 letter loss in visual acuity plus a greater than or equal to 75-micron increase in central subfield thickness.
- This strategic change was made purely for a competitive advantage and to align real-world clinical decision-making in the trial, not due to FDA requirements.

Investor Confidence and Extension Studies:
- Ocular Therapeutix plans to incorporate long-term open-label extension studies for both SOL trials, following the 2-year safety follow-up period.
- The extension study aims to generate valuable real-world insights into potential long-term benefits and is seen as crucial for physician confidence and market adoption.

Financial Position and Cash Guidance:
- The company ended the second quarter with over $390 million in cash and cash equivalents, having raised approximately $97 million through its ATM facility.
- The raised capital is aimed at supporting key initiatives, including investments in commercial infrastructure, planning for FDA-aligned future studies, and providing flexibility for potential expansion in NPDR and DME.