Christmas came a week early for Aerie Pharmaceuticals.
Christmas came a week early for Aerie Pharmaceuticals, Inc. The U.S. Food and Drug Administration approved Rhopressa, the company’s treatment to lower elevated intraocular pressure in glaucoma patients.
The FDA approved the drug on Monday, two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of Feb. 28, 2018, the company said. The approval came two months after an FDA advisory panel voted 9 to 1 to support Rhopressa. The panel strongly supported the idea that the efficacy of Rhopressa outweighed safety risks.
Aerie Chief Executive Officer Vicente Anido, Jr. called the drug’s approval “the single greatest achievement in Aerie’s history to date.” In a statement issued Monday, Anido said the approval of Rhopressa is “exciting news” for patients with open-angle glaucoma or ocular hypertension.
Rhopressa (netarsudil ophthalmic solution) 0.02%, is a novel once-daily eye drop. Phase III data from Rhopressa showed the triple-action eye drop lowered intraocular pressure in patients with glaucoma and ocular hypertension. The company had hoped Rhopressa would be placed for FDA review in 2016, but third-party manufacturing problems caused a delay.
With the FDA approval, Anido said the company is prepared to commercialize the drug. Aerie will hire 100 sales representatives in the first quarter of 2018 and launch the treatment by the middle of the second quarter.
“As the 2018 year progresses, it is our goal to make strides in gaining formulary coverage for commercial plans, which represent approximately half of the U.S. market. The other half of the U.S. market is covered through Medicare Part D, and we expect our formulary presence for this market to commence in January 2019,” Anido said.
During clinical testing, there were some concerns raised about the safety profile of Rhopressa, including eye redness, corneal deposits and conjunctival hemorrhage. While regulatory approval was expected, the safety issues had some analysts concerned. They believed the concerns would shrink market share for Rhopressa. The company has said a “deep dive” into the data shows that Rhopressa maintains a good safety profile.
“While this was widely expected by investors, we think it’s now up to Aerie to convince patients and practitioners that Rhopressa’s perceived side-effect profile is manageable and that the single-agent Rhopressa has a place in the ophthalmologist’s armamentarium. We’re encouraged that the final label was generally consistent with the draft provided at the October panel meeting with slight clarifications for corneal deposits and side effects,” Canaccord Genuity healthcare analyst Dewy Steadman said in a note this morning.
Despite the positive news, shares of Aerie are down this morning to $57.10 as of 11:27 a.m.
Not only does Aerie intend to launch Rhopressa in the early part of 2018, the company is looking to seek FDA approval for Roclatan, a combination of Rhopressa and market-leading prostaglandin analogue (PGA) latanoprost. In May, the company shared Phase III data that demonstrated Roclatan achieved statistical superiority in lowering intraocular pressure over each of its component drugs.
Glaucoma can cause blindness if it is left untreated. Glaucoma is not curable, and vision lost cannot be regained. However, some medications my halt disease progression.
