Aerie bags an early OK for its self-described blockbuster glaucoma drug Rhopressa, recruiting 100 reps
The FDA has approved Aerie’s $AERI glaucoma drug Rhopressa, hitting the green light a full two months ahead of the PDUFA date.
This wasn’t a big surprise. An expert panel offered a lopsided 9-to-1 vote in its favor, happy to see a new drug would be a welcome addition to the pharmacopeia available for the eye disease.
That vote came on the heels of an insider FDA review that concluded the drug reduced elevated intraocular pressure in the eye — the key task in the field. But the review also noted that the comparator drug, the generic timolol ophthalmic solution 0.5% twice daily, was more effective for the more severely afflicted patients.
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