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EA Policies for Single Patient
At this time Cambium Bio is not offering expanded access. Cambium Bio will periodically review its expanded access policy for Elate Ocular® as the clinical development program progresses. Factors that may influence future decisions regarding expanded access include:
Clinical Trial Progress: The availability of Elate Ocular® for expanded access may be considered upon successful completion of key clinical trials and demonstration of a positive benefit-risk profile.
Drug Supply: Increased manufacturing capacity and drug supply may allow for expanded access in the future.
Regulatory Guidance: Cambium Bio will continue to monitor and adhere to relevant regulatory guidance on expanded access programs.