Cambium Bio Secures Funding for Pivotal Phase 3 Trial of Elate Ocular
News related to:Cambium Bio Limited · 2 min read
SYDNEY, Sept. 16, 2026 /CourierPR/ -- Cambium Bio Limited, a clinical-stage regenerative medicine company based in Sydney, has secured A$10.85 million to initiate a pivotal Phase 3 trial of Elate Ocular®, a potential first-in-class biologic therapy for moderate to severe dry eye disease (DED). The funding package includes A$7.1 million in firm commitments from strategic shareholders and an A$3.75 million secured facility that pre-finances the company’s FY2027 Research and Development Tax Incentive refund.
The company’s lead product, Elate Ocular®, is derived from human platelet lysate and is being developed as a biologic therapy for DED. To the best of Cambium Bio’s knowledge, no biologic therapy has been approved for the treatment of DED, and Elate Ocular® could be the first. The program has received FDA Fast Track designation, which expedites the development and review process for drugs and biologics that are intended to address unmet medical needs.
The pivotal trial, CAMOMILE-2, is a single 475-patient Phase 3 trial that the U.S. Food and Drug Administration (FDA) has confirmed is sufficient to support a Biologics License Application (BLA). The trial is targeted for initiation in the fourth quarter of 2026. Topline data from the trial are expected in late calendar 2027, and if the trial meets its co-primary sign and symptom endpoints, the company intends to file a BLA with the FDA in 2028.
Karolis Rosickas, Chief Executive Officer of Cambium Bio, stated, “Our strategic shareholders have backed Cambium Bio at a premium to market, and that support now gives us the funding to start the pivotal trial of Elate Ocular®. Dry eye disease still has no approved biologic therapy. With one pivotal trial agreed with the FDA, Fast Track designation, and the funding in place to initiate that trial, our path is clear: topline data in late 2027 and a BLA filing in 2028.”
The placement is conditional on shareholder approval at the Company's 2026 Annual General Meeting. Full details are available in the Company's ASX announcement dated 16 September 2026.