GREENWOOD VILLAGE, Colo. (TheStreet) -- The announcement by Regeneron Pharmaceuticals (REGN) on Tuesday that it will accelerate diabetic macular edema approval (DME) filings for its lead drug Eylea by one year is another reminder of the ridiculous and misleading statements made by Ampio Pharmaceuticals (AMPE) regarding the clinical development of its DME drug candidate Optina.
Ampio tells investors that a single, "pivotal" phase III study of Optina lasting just 12 weeks will be sufficient to seek FDA approval as a treatment for DME.
That's a remarkable claim, completely untethered from reality.
Consider Regeneron, which announced positive, one-year results from two large phase III studies of Eylea in DME on Tuesday morning. Regeneron had thought that two years of positive data from these trials would be necessary before supplemental new drug applications in DME could be filed in the U.S. and Europe.Not so any longer. Regeneron will file Eylea for DME approval before the end of this year based on the one-year trial results. Bayer, which markets Eylea in Europe for Regeneron, will do the same in Europe. "Concerted discussions with the FDA led us to make that change," said Regeneron CEO Leonard Schleifer to Forbes' Matt Herper. Regeneron spends considerable time and energy convincing FDA to review Eylea based on a year's worth of data, yet Ampio wants investors to believe the same regulators will be copacetic with a single clinical trial of 12 weeks on Optina. Absurd. A previous study of Optina in DME failed. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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