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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