The FDA's insider view on Aerie’s glaucoma drug: Yes on efficacy, but…
The FDA had some encouraging words for Aerie’s new glaucoma drug Rhopressa, but there’s a significant caveat that might come back to haunt the biotech as it hunts an approval.
In the internal review offered up by the agency two days ahead of the mission-critical panel discussion and vote, FDA insiders give the data a thumbs up on efficacy, but note that the comparator therapy was better than the drug in the more severely afflicted patients included in their Phase III studies.
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