Where Art Thou O treatment for diabetic neuropathy: the sequel.
Yigit Can GuldikenAyesha MalikIoannis N PetropoulosHoda GadEinas ElgassimIuliia SalivonGeorgios PonirakisUazman AlamRayaz A MalikPublished in: Expert review of neurotherapeutics (2023)
Quantitative sensory testing, intraepidermal nerve fiber density, and especially corneal confocal microscopy remain an after-thought, demoted at best to exploratory secondary endpoints in clinical trials of diabetic neuropathy. If pharma are to be given a fighting chance to secure approval for a new therapy for diabetic neuropathy, the FDA needs to reassess the evidence rather than rely on 'opinion' for the most suitable endpoint(s) in clinical trials of diabetic neuropathy.