Cambium Bio Advanced Dry Eye Biologic to Phase 3
The FDA granted Fast Track status to the therapy, which is now set for a 515-patient trial beginning in late 2026.
Updated on Oct. 2, 2026 in Biotech
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Cambium Bio has advanced its Elate Ocular biologic for moderate to severe dry eye disease into Phase 3 clinical testing. The company recently confirmed the candidate received Fast Track designation from the FDA.
Why it matters
This advancement moves the investigational therapy, which utilizes a human platelet lysate platform, closer to potential regulatory approval. The transition follows the company's efforts to address the clinical demand for treatments targeting persistent ocular surface discomfort.
The CAMOMILE-2 study will evaluate corneal staining and patient-reported eye discomfort as primary endpoints for the Elate Ocular biologic. This candidate is built on a fibrinogen-depleted human platelet lysate platform, a delivery method that uses human blood components stripped of clotting factors to potentially promote healing.
The players
Cambium Bio
A biotechnology firm focused on developing regenerative ocular therapies using human-derived platelet lysate platforms.
FDA
The United States federal agency responsible for regulating biological products and granting priority review designations for serious conditions.
The details
The treatment functions by leveraging human platelet lysate — a substance derived from concentrated platelets that contains growth factors and proteins which may stimulate tissue repair. By depleting the fibrinogen — a glycoprotein essential for blood clotting — the platform aims to provide these biological benefits without the risk of clotting associated with untreated plasma. The upcoming trial will specifically measure corneal integrity and subjective symptom relief in patients suffering from moderate to severe forms of the condition.
Timeline
Q4 2026: Commencement of patient enrollment for the CAMOMILE-2 study.
Q4 2027: Expected release of topline Phase 3 data.
Mid-2028: Planned submission of a Biologics License Application.
The Tech Race
This development places Cambium Bio within a crowded pipeline of regenerative medicine candidates seeking to move beyond traditional lubricant-based ocular treatments. The progression of Elate Ocular toward a Phase 3 milestone follows a trend of leveraging human-derived biologics to compete with existing immunomodulatory dry eye drugs.
Patients with moderate to severe dry eye disease in the United States and Australia will be the initial participants for this new therapy during the upcoming study. Availability for the broader public depends entirely on successful trial results and the subsequent regulatory approval process projected for mid-2028.
The takeaway
The transition to a 515-patient Phase 3 trial establishes the next major hurdle for the company's platform in treating chronic ocular discomfort. Industry observers should watch for the topline data release in Q4 2027 to see if the biological platform meets its clinical endpoints.
What happens next
Cambium Bio is scheduled to begin patient enrollment for the CAMOMILE-2 study in Q4 2026.
Further reading
For more on the current landscape of regenerative therapies, see our Biotech section.
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