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Core Requirements for the List: For a substance to be included on the 503B Bulks List, the FDA must determine there is a clinical need

Ocular hypertension triggers the production of pro-inflammatory cytokines by immune cells, which in turn drives the transformation of neuroprotective astrocytes into a neurotoxic A1-reactive phenotype, ultimately leading to RGC degeneration [45]

To be eligible for this treatment, adults generally need to have a Body Mass Index (BMI) of 30 or higher, or a BMI of 27 or higher if they also have conditions like type 2 diabetes or high blood pressure

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