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Cambium Bio (ASX:CMB) has flagged approval from the U.S. FDA for phase three of a clinical trial using its Elate Ocular product to treat moderate to severe dry eye disease.
The market clearly liked the news – Cambium jumped more than 40% in the second hour of trade; the latest winner in a small basket of biotech stocks progressing towards late-stage approvals and commercialisation.
In Cambium’s own words, the Phase 3 trial represents a final step towards market registration for its Elate Ocular product, with the third trial typically being the final in the FDA’s approval ringer. The Phase 3 program is ultimately geared to acquire a Biologics Licence Application (BLA.)
Trial sites in both the U.S. and Australia – “and select other countries” – will constitute Phase 3; Cambium won FDA Fast Track designation for Elate last December.
Elate Ocular are eye drops marketed by Cambium as regenerative in nature with “tissue rejuvenation” as a (proposed) selling point. The eye drops are derived from a type of platelet called lysate which, Cambium intends to prove, can support the health of the surface of the eye.
The Phase 3 trial will enrol 800 patients and test the product against placebo. But it could be a wait – the company expects top-line data in mid-2026.
“FDA approval of our Phase 3 protocol marks a pivotal milestone in Elate Ocular’s development journey,” Cambium CEO Karolis Rosickas said.
“The trial design reflects extensive consultation with regulatory experts and key opinion leaders to ensure we meet the FDA’s requirements for registration.
“With Fast Track designation now secured and the protocol approved, we are well-positioned to advance Elate Ocular through its final stages of clinical development.”
CMB last traded at 56cps.
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