Cambium Bio Cuts Path to FDA Approval From Two Trials Down to One for Dry Eye Drug
Cambium Bio (ASX: CMB) has secured FDA confirmation that a single pivotal Phase 3 trial is an acceptable pathway to a Biologics License Application for Elate Ocular, materially reducing capital requirements and accelerating the timeline to potential market authorisation for moderate-to-severe dry eye disease.
Key Takeaways
- The FDA confirmed at a Type D meeting on 22 April 2026 that a single adequate and well-controlled pivotal Phase 3 study, supported by confirmatory evidence, is an acceptable BLA pathway for Elate Ocular in moderate-to-severe dry eye disease.
- This single-trial pathway replaces the historical dual-study requirement, materially reducing clinical development costs, compressing timelines, and improving the probability of regulatory success for Cambium Bio.
- The CAMOMILE-3 Phase 3 study (n=400, randomised, double-masked, vehicle-controlled) remains the agreed pivotal programme, with First Patient In expected later in 2026.
- Cambium Bio holds Fast Track Designation for Elate Ocular, enabling rolling BLA submission and allowing confirmatory evidence to be supplemented during and after the pivotal study's open-label extension period.
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