Cambium Bio Wins FDA Backing for Single Pivotal Trial for Elate Ocular

Regeneus Ltd. ( (AU:CMB) ) has issued an announcement.

Cambium Bio has secured U.S. FDA confirmation that a single, well-controlled pivotal Phase 3 trial plus confirmatory evidence will be sufficient to support a Biologics License Application for its Elate Ocular treatment for moderate-to-severe dry eye disease. This aligns the programme with the FDA’s new regulatory default of one pivotal trial, replacing the previous two-trial expectation and validating Cambium’s existing Phase 3 design.

The shift to a single-trial pathway is expected to materially cut development costs, simplify operations, and accelerate patient enrolment by consolidating activity into the CAMOMILE-3 study of 400 evaluable subjects. Combined with Fast Track status and the option for rolling BLA submission, the new pathway is projected to shorten time to potential approval and improve the overall probability of regulatory success for Elate Ocular.

Cambium plans to initiate the pivotal Phase 3 study later in 2026, after which it will work with the FDA to define the precise nature of confirmatory evidence, potentially including additional nonclinical work on mechanism of action. The reduced capital needs and clearer regulatory runway may strengthen Cambium’s position in the competitive dry eye market and provide greater visibility for investors on the route to commercialisation.

More about Regeneus Ltd.

Cambium Bio Limited is a clinical-stage regenerative medicine company focused on ophthalmology and tissue repair. Its lead product candidate, Elate Ocular, targets moderate-to-severe dry eye disease, positioning the company within the high-need ocular therapeutics market.

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