Cambium Bio Advances Dry Eye Treatment with Dual Ethics Approvals for Phase 3 Trials
Cambium Bio has secured ethics approvals in Australia and the US to initiate pivotal Phase 3 trials of Elate Ocular, targeting moderate to severe dry eye disease, with patient dosing expected in October 2025.
- Ethics approvals granted by Bellberry HREC (Australia) and Advarra IRB (US)
- Phase 3 trials to enrol approximately 800 patients globally
- First patient dosing anticipated in October 2025
- Top-line data expected in Q3 2026
- Trials designed to support regulatory registration and Biologics License Application
Ethics Approvals Clear Path for Phase 3 Trials
Cambium Bio Limited (ASX, CMB), a clinical-stage regenerative medicine company focused on ophthalmology, has reached a significant milestone by obtaining ethics approvals to commence its Phase 3 clinical trials of Elate Ocular in both Australia and the United States. The approvals, granted by Bellberry Human Research Ethics Committee in Australia and Advarra Institutional Review Board in the US, pave the way for the company to initiate patient dosing as early as October 2025.
Aiming to Address Unmet Needs in Dry Eye Disease
Elate Ocular is a novel biologic eye drop derived from fibrinogen-depleted human platelet lysate, designed to treat moderate to severe dry eye disease, a condition that affects millions worldwide with limited effective therapies. The upcoming Phase 3 trials, named CAMOMILE-2 and CAMOMILE-3, will randomise around 800 patients globally in a double-masked, placebo-controlled study. The trials will assess both signs and symptoms of dry eye disease, focusing on corneal staining and patient-reported discomfort.
Global Multi-Regional Clinical Trial Program
These trials form part of a broader multi-regional clinical trial program, reflecting Cambium Bio’s strategic approach to secure regulatory approvals across major markets. The company has already received FDA clearance for the clinical protocol earlier this year, and the current ethics approvals mark the next critical step towards regulatory submission. Cambium Bio aims to submit a Biologics License Application following the completion of these Phase 3 studies.
Looking Ahead
CEO Karolis Rosickas highlighted the importance of these approvals, describing them as pivotal for advancing Elate Ocular towards commercialization. With site activations and operational readiness underway, the company is focused on meeting its timeline for first patient dosing in October 2025 and expects to report top-line data by the third quarter of 2026. Success in these trials could position Cambium Bio as a key player in the regenerative medicine space for ophthalmology.
Bottom Line?
Cambium Bio’s Phase 3 trial approvals set the stage for a critical test of Elate Ocular’s potential to transform dry eye treatment.
Questions in the middle?
- How quickly will Cambium Bio be able to activate trial sites and begin patient recruitment?
- What interim data milestones might investors expect before the top-line results in Q3 2026?
- How will Elate Ocular compare to existing dry eye therapies if approved?