FDA

FDA experts give a thumbs-up to Aerie Pharma’s glaucoma drug

Aerie Pharmaceuticals $AERI appears to be on a glide path to an FDA approval for its glaucoma drug Rhopressa.

 Vicente Anido

An expert panel convened by the FDA offered a clear thumbs up, voting 9-1 that the efficacy of the drug outweighed any safety risks.

The biotech’s stock slipped 2% after the vote on Friday.

That decision came on the heels of an insider FDA review that concluded the drug reduced elevated intraocular pressure in the eye. 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.

That may well come back to haunt the company if the FDA comes through with an OK, as expected.

Needham analyst Serge Belanger noted:

“All ophthalmologists on the panel expressed excitement of having a new drug that is dosed once-daily, is safe (and) can be used with other treatments.”

A bullish Aerie CEO Vicente Anido has already touted Rhopressa as a likely blockbuster able to earn more than $1 billion a year, even though the biotech had to get the FDA’s permission to change the endpoint for its second late-stage study of Rhopressa in order to avoid back-to-back failures.

Aerie is also two for two on its pivotal Phase III studies for Roclatan, a combo drug that combines the generic latanoprost to Rhopressa.


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