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Ampio to consult with FDA on registration studies for diabetic macular oedema drug

This article was originally published in Scrip

Executive Summary

Ampio Pharmaceuticals has announced plans to request a meeting with the US FDA with a view to starting registration studies for Optina (repurposed danazol), its treatment for diabetic macular oedema, after the company halted a Phase II trial of the drug early after a planned interim review. Interestingly, the preliminary assessment of the data shows a benefit with an ultra-low dose of Optina but no apparent benefit at the high dose.

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