At the end of 2016, Aerie Pharmaceuticals had 95 employees and a lead drug candidate, Rhopressa, it hoped to launch next year. Now, Aerie has that hoped-for FDA approval—and it's preparing to hire 100 sales staffers to get the new glaucoma med to market.
The FDA approved Aerie's Rhopressa Monday to lower elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The nod followed a 9-1 vote in favor of approval by an FDA advisory panel back in October.
Aerie CEO Vicente Anido was exultant in a Monday statement, calling the development the "single greatest achievement in Aerie's history to date," adding that it "represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians." Analysts with Canaccord Genuity predict the med will bring in $443 million by 2027.
RELATED: Aerie climbs after FDA briefing concurs with efficacy claims
Rhopressa hasn't had an easy path through the FDA. Back in 2015, the med came up short in a phase 3 trial, and the FDA allowed Aerie to switch primary endpoints in a second phase 3. Rhopressa then hit the mark in that second study. If not for the FDA's pivot, Rhopressa would've failed the second phase 3 trial.
In a presentation (PDF) last month, Aerie execs touted their plan to hire 100 sales reps immediately after approval to target 12,000 prescribers, or 80% of the market. Aerie has already started initial market access meetings with government and commercial payers, according to the presentation.
Looking ahead, the company plans to file for approval by the second quarter next year with its other late-stage candidate, Roclatan, to treat glaucoma. That med combines Rhopressa with the widely prescribed glaucoma med latanoprost, originally marketed as Xalatan from Pfizer. Pfizer's drug brought in $1.75 billion in 2010 before generics hit in 2011.
RELATED: After a painfully slow 2016, FDA's racking up drug approvals lickety-split
According to its presentation, Aerie plans to position Rhopressa as an adjunctive therapy and Roclatan as a first-line treatment. Canaccord Genuity analysts see Roclatan as the bigger opportunity, predicting the med will bring in $989 million in 2027.
In a note to clients, Canaccord Genuity analyst Dewey Steadman wrote that while the Rhopressa approval 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."
Monday's news marked the FDA's 43rd new drug approval so far this year, according to its website, as the agency continues on a zippy pace that bodes well for the industry. Last week, the regulator signed off on Medimetrik's Xepi, a treatment for impetigo due to Staphylococcus aureus or Streptococcus pyogenes. Last year, the FDA approved just 22 new drugs.