fda2outsideweb

Aerie’s glaucoma drug gets strong preliminary FDA opinion

pharmafile | October 12, 2017 | News story | Sales and Marketing Aerie, Aerie Pharmaceutical, FDA, Glaucoma, Rhopressa, pharma 

In a preliminary review of the drug, the FDA has judged that Aerie Pharmaceutical’s experimental glaucoma treatment Rhopressa (netarsudil) effectively reduces intraocular pressure when administered once a day. The drug is currently being assessed in the indication of open-angle glaucoma or ocular tension.

The positive review comes just two days before a meeting to decide whether the drug should be approved in the US market. Agency reviewers did however question the effectiveness of a twice-daily regimen of the rho kinase inhibitor in patients with the highest degree of eye pressure.

The news from the FDA proved a huge boon for Aerie, as its shares leapt 19% on the announcement.

Rhopressa was previously tested in the Rocket 1 study in 2015, where it failed to lower intraocular eye pressure compared to existing treatment timolol. In the Rocket 2 trial, where baseline intraocular pressure was restricted compared to the first study, both once-daily and twice-daily regimens proved effective.

Caused by damage to the optic nerve including increased eye pressure, glaucoma affects 2.7 million people in the US and is the second-leading cause of blindness worldwide. The number of those affected in the US is expected to grow to four million by 2030.

Matt Fellows

Related Content

GSK’s Jemperli accepted for FDA review for endometrial cancer treatment

GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …

FDA approves ImmunityBio’s Anktiva bladder cancer treatment

ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …

Roche’s Alecensa approved by FDA as lung cancer treatment

Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …

Latest content