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.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.