- Shares in Aerie Pharmaceuticals rocketed up by as much as 40% Thursday morning, fueled by an announcement from the California-based biotech late Wednesday that its experimental eye drop drug met the main objective of a Phase 3 study.
- Designed for the treatment of glaucoma, Aerie's Roclatan (netarsudil/latanoprost opthalmic solution) lowered intraocular pressure (IOP) more than either the commonly used latanoprost or the company's other experimental drug Rhopressa (netarsudil).
- Aerie now expects to submit a New Drug Application to the Food and Drug Administration for Roclatan in the first half of 2018, provided that safety results from a 12-month Phase 3 study set to read out later this year are positive.
Aerie, which currently has no marketed products, hopes to make the jump to commercial stage over the next two years.
Rhopressa, also intended as a glaucoma treatment, was submitted to the FDA in February 2017 and could win approval early next year. The regulator has set a target action date for February 28, 2018.
Roclatan, on the other hand, combines the active ingredient in Rhopressa with latanoprost, a widely prescribed prostaglandin analog used to lower IOP. In the recently announced results for the Mercury 2 study, Roclatan proved statistically superior to both Rhopressa and latanoprost in reducing IOP.
"We believe this [result] was impressive not only in the magnitude of IOP reduction at all time points, but low inter-trial variability combined with data in nearly ~3,000 patients could comfort FDA in knowing the data in-hand is sufficiently robust to predict performance post-approval," wrote Canaccord Genuity analyst Dewey Steadman in a May 24 note.
A previous Phase 3 trial, dubbed Mercury 1, showed a similar effect in its primary 90-day efficacy analysis. Safety data from that study are expected in the third quarter and, if positive, would support Aerie's filing with the FDA.
Roclatan's results, along with a nearing regulatory decision for Rhopressa, mark Aerie's progress in moving closer to market — achievements that could make it an attractive acquisition target, Steadman suggested.
The glaucoma market is sizable, estimated by Aerie at nearly $3 billion currently. Latanoprost commands over a third of that market, but Aerie believes Roclatan results show a potential "greater IOP-lowering effect than any other currently approved glaucoma product."
By the time Roclatan reaches the desks of reviewers at the FDA, though, a new competitor could be on the scene. Valeant Pharmaceuticals expects to win approval of Vyzulta (latanoprostene bunod) by August, after remedying a manufacturing-related problem which had led to an initial rejection.
Vyzulta is a prostaglandin analog that also proved to lower IOP. Roclatan could have an advantage though, in that it reduces pressure through all known mechanisms of actions, while Vyzulta works mainly by reducing fluid outflow through the trabecular and uveoscleral pathways.