Just over a year after securing approval for its glaucoma drug, Rhopressa, Aerie Pharmaceuticals has followed up with an approval for its second such treatment engineered to tackle hard-to-treat cases of the common eye disease that if untreated typically culminates in blindness.
The new approval, granted by the FDA on Tuesday, is for Rocklatan — a once daily eye drop comprising the widely used generic latanoprost and netarsudil, the active ingredient in Rhopressa.
Glaucoma is characterized by damage to the optic nerve, usually caused by fluid building up in the front part of the eye, which increases pressure inside the eye. This leads to the progressive degeneration of retinal cells, resulting in vision loss and eventually blindness. According to estimates by the Glaucoma Research Foundation, over 3 million Americans have glaucoma but only half of those know they have it.
Rhopressa works by restoring outflow through the trabecular meshwork — the eye’s primary fluid drain and the diseased tissue responsible for elevated intraocular pressure (IOP) in glaucoma — while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway, Aerie said.
Rocklatan’s approval was based on two late-stage studies: MERCURY 1 and MERCURY 2, in which the drug demonstrated statistically superior IOP reduction over latanoprost or netarsudil alone at every measured time point. It is also being evaluated in the MERCURY 3 pivotal study for European regulators.
“Rocklatan has the ability to address higher pressures and more-difficult-to-address glaucoma cases, given the drug contains latanoprost. Latanoprost is an added prostaglandin that could be used to increase drainage outflow. From the MERCURY studies, >60% of patients taking Rocklatan achieved IOP reductions of >30% (2x greater than what was seen by patients taking latanoprost alone). By 2021, we expect Rocklatan to have the same market share as Rhopressa, which we believe could be surpassed starting in 2022,” Cantor Fitzgerald’s Elemer Piros wrote in a note.
In the lead up to the decision for Rhopressa, FDA staff had highlighted that the drug did not work as well as the comparator therapy (timolol ophthalmic solution) in the more severely afflicted patients (with IOP ≥ 25 mmHg) included in their Phase III studies. Given that Rocklatan is designed to tap into the spectrum of IOP-lowering mechanisms, it could be suited for patients with such advanced disease.
Rhopressa was launched last April, and made about $24.2 million over the course of the year. Rocklatan, expected to hit the market in the second quarter of 2019, is already under review for reimbursement by major players, the company said.
“(I)nsurance coverage pickup could be faster as contracts with payers will already be in place (from Rhopressa),” Mizuho analyst Difei Yang wrote in a note.
In a separate release, Aerie management projected full-year 2019 revenue in the range of $110 million to $120 million for Rhopressa and Rocklatan combined. “We see this guidance as conservative and we believe there is a reasonable chance for Aerie to outperform in 2019,” Yang added.
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