Ampio Pharmaceuticals, a
clinical stage biopharmaceutical company developing drugs for the treatment of
inflammation, eye disease, kidney disease, CNS disease, metabolic, disease and
male sexual dysfunction today announced that a pre-IND meeting with the FDA's
ophthalmology division of the Center for Drug Evaluation and Research (CDER)
took place on July 31st 2012 seeking guidance for a clinical trial path for
Optina.
·
The meeting followed a letter from the FDA
providing guidance for the path of approval of Optina™ in the USA.
·
The FDA agreed to Ampio's proposed
indication for Optina™ as a drug for the treatment of Diabetic Macular Edema
(DME) in adults.
·
The FDA agreed that the approval process
through the 505(b)2 pathway is acceptable.
·
The FDA raised no safety or CMC concerns.
·
The FDA agreed that no additional
non-clinical studies are necessary and that guidance for the dose and
inclusion/exclusion criteria for this larger trial may be drawn from the
recently completed successful Canadian trial.
·
The proposed study, agreed by the FDA to be
conducted by Ampio, will be based on similar end points as the intraocular
injectable drug, LucentisAmpio Pharmaceuticals, a clinical stage biopharmaceutical
company developing drugs for the treatment of inflammation, eye disease, kidney
disease, CNS disease, metabolic, disease and male sexual dysfunction today
announced that a pre-IND meeting with the FDA's ophthalmology division of the
Center for Drug Evaluation and Research (CDER) took place on July 31st 2012
seeking guidance for a clinical trial path for Optina
