FDA Approves Phase 3 Clinical Trial Protocol for Elate Ocular.

Cambium Bio Limited (ASX: CMB) has received FDA approval for the Phase 3 clinical trial protocol of Elate Ocular a biologic treatment for moderate to severe dry eye disease This milestone advances Elate Ocular toward market registration following its FDA Fast Track designation in December 2024 The trials CAMOMILE 2 and CAMOMILE 3 will be conducted as multi regional clinical trials MRCTs across Australia the United States and select countries 

The Phase 3 trials will enroll 800 patients evaluating safety and efficacy over a nine week treatment period with a subset undergoing a 43 week safety follow up Cambium Bio anticipates first patient enrollment by mid 2025 top line data readout in mid 2026 and Biologics License Application BLA submission upon successful completion Chief Executive Officer Karolis Rosickas highlighted this milestone as pivotal for Elate Oculars development and commercialization.

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