Ocular Therapeutix's Q4 2024: Unraveling Contradictions in Study Designs, Strategic Labeling, and Redosing Plans

These are the key contradictions discussed in Ocular Therapeutix's latest 2024Q4 earnings call, specifically including: SOL-R study design and size, expectations for label differentiation and strategic value of AXPAXLI, and the purpose of redosing in SOL-1:



Clinical Trial Success and Efficiency:
- Ocular Therapeutix's clinical trials are progressing successfully, with SOL-1 completing randomization ahead of schedule in December 2024, enrolling 344 subjects across more than 100 clinical sites.
- This success is attributed to their strategic trial design and patient selection, which has resulted in high patient retention and alignment with FDA requirements.

Redosing and Trial Design Changes:
- The FDA approved redosing in SOL-1 at weeks 52 and 76, allowing for extended treatment intervals.
- This amendment is aimed at demonstrating best-in-class durability and flexibility, potentially leading to a label with six to twelve month dosing intervals.

SOL-R Enrollment and Efficient Trial Design:
- SOL-R enrollment has been strong, with 311 subjects enrolled as of January 10, 2025, and is being streamlined to 555 subjects due to updated SOL-1 redosing.
- The reduction in SOL-R size is due to increased efficiency from combining safety data from both trials, enhancing capital efficiency while maintaining robust statistical powering.

Financial Strength and Strategic Focus:
- Ocular Therapeutix ended 2024 with a cash balance of $392 million, sufficient to fund operations into 2028.
- The company remains disciplined and focused on execution of critical registrational trials in wet AMD, aiming to redefine the retina experience and expand into other retinal indications.