Aerie Pharmaceuticals announced exciting efficacy results from the second part of its Phase 3 clinical trial of Roclatan at the end of last month.
Roclatan is devised for a group of eye conditions called glaucoma, and it works by lowering the intraocular pressure (IOP) that is characteristic of the disease. To learn more about glaucoma, including different types and current treatment options, click here.
In this Phase 3 study, Aerie found that Roclatan lowered IOP more than the alternatives: both commonly used latanoprost (a prostaglandin) and another experimental drug called Rhopressa, which is consistent with the findings from the primary registration trial of this drug.
The reason for this improvement could be attributed to the fact that Roclatan combines four different agents: a netarsudil, a rho kinase, a norepinephrine transporter inhibitor, and a prostaglandin, to lower IOP. This is a novel and more robust way to approach treatment of glaucoma.
Dewey Steadman, an analyst on the trial said that the results were impressive…
“…not only in the magniturde of IOP reduction at all time points, but low inter-trial variability ombined with data in nearly ~3,000 patients could comfort FDA in knowing the data in-hand is sufficiently robust to predict performance post-approval.”
Aerie now expects to submit a New Drug Application (NDA) to the U.S. FDA for Roclatan in the first half of next year, after the official safety results for the yearlong Phase 3 study are deemed positive later this year.
While there are treatment options currently available for glaucoma, Roclatan has the potential to streamline the therapy process overall.
Stay tuned in the coming months as important benchmarks are reached for this novel new drug!