Cambium Bio Advances Elate Ocular Into Phase 3

Sydney, Australia, September 16, 2026

Cambium Bio Secures Funding for Pivotal Trial

The CAMOMILE-2 Phase 3 study is planned as a single pivotal trial enrolling approximately 475 patients with moderate to severe dry eye disease. According to Cambium Bio, the U.S. Food and Drug Administration (FDA) has confirmed that the single trial could be sufficient to support a future Biologics License Application (BLA) if the study successfully achieves its required endpoints. The company is targeting topline results in late 2027, followed by a potential BLA submission in 2028, subject to successful clinical results and regulatory requirements. The strategic financing includes a placement priced at A$0.48 per share, while the additional secured facility will pre-finance the company’s FY2027 R&D Tax Incentive refund. The financing announcement marks another step in Cambium Bio’s development of biologic therapies for ophthalmology and tissue repair. The company is developing Elate Ocular using its proprietary human platelet lysate technology, with the candidate being investigated as a potential treatment for patients whose dry eye disease is more severe and may require additional therapeutic options. The company described the financing as its fourth consecutive equity raise priced at a premium to the market price, although the placement remains subject to shareholder approval at its 2026 Annual General Meeting.

Elate Ocular Targets Unmet Dry Eye Disease Needs

Elate Ocular is a biologic derived from human platelet lysate and is being developed specifically for moderate to severe dry eye disease. Cambium Bio stated that, to its knowledge, no biologic therapy has yet been approved specifically for dry eye disease, giving Elate Ocular the potential to become a first-in-class biologic if clinical development and regulatory review are successful. The program has also received FDA Fast Track designation, which is intended to facilitate development and regulatory interactions for therapies addressing serious conditions with unmet medical needs. Dry eye disease is associated with inadequate tear production, excessive tear evaporation or instability of the tear film, and can cause symptoms including ocular discomfort, irritation, burning and visual disturbance. More severe disease can substantially affect everyday activities and quality of life. The development of biologic approaches could potentially broaden the therapeutic strategies available for patients with significant dry eye symptoms, although the clinical benefits of Elate Ocular remain to be established through the planned Phase 3 study.

Phase 3 Data Could Support Future BLA Filing

The upcoming CAMOMILE-2 study is expected to evaluate both sign and symptom endpoints, reflecting the multidimensional nature of dry eye disease and the need to assess changes in both objective clinical measures and patient experiences. Cambium Bio has stated that successful achievement of the trial’s co-primary endpoints would support its planned regulatory pathway toward a BLA submission in 2028. The transition into a pivotal Phase 3 program represents an important development milestone for the company and its regenerative medicine platform. With funding secured, FDA alignment on the pivotal study design, and Fast Track designation, Cambium Bio is preparing to advance Elate Ocular into late-stage clinical development. However, the candidate remains investigational, and its safety and efficacy will ultimately depend on the results of CAMOMILE-2 and subsequent regulatory assessment. If the study produces supportive results, the data could form the clinical foundation for a future U.S. regulatory application for the treatment of moderate to severe dry eye disease.

Source: Cambium Bio press release