Sydney-based Cambium Bio (ASX:CMB) announced that the US Food and Drug Administration confirmed a streamlined approval pathway for its flagship candidate, Elate Ocular.
Following a Type D meeting held on April 22, the agency agreed that a single, well-controlled pivotal clinical study—supplemented by confirmatory evidence—is sufficient to support a biologics licence application for treating moderate-to-severe dry eye disease.
The decision marks a departure from the historical requirement of two independent pivotal trials, aligning instead with an updated regulatory policy recently established in the New England Journal of Medicine.
By allowing the CAMOMILE-3 Phase 3 study to serve as the primary evidence package, the FDA has effectively reduced the clinical development capital required and accelerated the overall timeline for market entry.
The "single-trial" approach is designed to consolidate statistical risk into one well-powered study, involving 400 evaluable patients over a nine-week masked treatment period.
Furthermore, Elate Ocular maintains its Fast Track Designation, originally granted in late 2024.
The status permits a rolling BLA submission, enabling Cambium Bio to submit portions of its application as data becomes available rather than waiting for the entire package.
At the time of reporting, Cambium Bio’s share price was $0.385.