This Biotech Yo-Yos After FDA Panel Recommends Glaucoma Drug
A split Food and Drug Administration committee voted Friday to recommend approval for Aerie Pharmaceuticals‘ (AERI) glaucoma drug Rhopressa — sending the company’s stock yo-yoing after it was briefly halted in early trades.
XAutoplay: On | OffOn the stock market today, Aerie popped as much as 5%, dipped as much as 3.4% and ended the day down 2.4% at 61.45. At the same time, the biotech group collectively lost 0.8% but stayed near a 22-month high.
The vote of the Dermatologic and Ophthalmic Drugs Advisory Committee puts Aerie one step closer to gaining full approval for Rhopressa, which aims to reduce increased pressure within the eye that’s associated with glaucoma. The FDA doesn’t have to follow the committee’s recommendation.
Committee members unanimously agreed that clinical trials support the efficiency of Rhopressa in reducing pressure within the eye in patients with open-angle glaucoma, in which the eye’s drainage canals become clogged over time, and in those with abnormally high pressure in the eye.
But the committee voted 9-1 on whether the efficiency of the drug outweighs risks associated with it. Rhopressa has been associated with inflammation and discharge near the eye and a whorl pattern on the eye that usually doesn’t impact vision.
IBD’S TAKE: An onslaught of strong biotech news has sent the group to a 22-month high. Among those spiking the group include a biotech with an epilepsy drug, another with a multiple-myeloma drug and a French biotech that could be acquired by Novartis. Visit IBD Industry Themes for a closer look at recent catalysts driving the group.
Needham analyst Serge Belanger noted that the only dissenting vote was from a biostatistician.
“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,” he wrote in a note to clients.
The FDA also noted in documents posted earlier this week, ahead of the committee meeting, that once-daily Rhopressa was found in three Phase 3 studies to be less effective than another drug, called timolol ophthalmic solution, given twice daily.
Rhopressa is set to go before the full FDA on Feb. 28, Aerie said in a news release.
“We believe there are significant unmet medical needs in the treatment of patients with open-angle glaucoma and ocular hypertension, and we are very excited about the prospects for Rhopressa,” Chief Executive Vicente Anido said in a statement.
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