SAN FRANCISCO — Upon FDA approval of the fixed-dose glaucoma treatment Rocklatan, Aerie Pharmaceuticals’ next step is launching the product.
U.S. physicians are “excited about using it in their practices,” Aerie president and chief operating officer Tom Mitro told Healio.com/OSN during the American Glaucoma Society meeting.
Rocklatan (netarsudil 0.02%/latanoprost 0.005% ophthalmic solution) is indicated for reduction of IOP in patients with open-angle glaucoma or ocular hypertension. The approval, which Aerie announced on March 12, is based on data from two phase 3 trials in which Rocklatan not only reached its primary efficacy endpoints but also demonstrated IOP reduction of 30% or more in greater than 60% of patients, Mitro said. Furthermore, the studies showed twice as many patients achieved pressures of 16 mm Hg or less on Rocklatan vs. latanoprost, he added.
“One of the most exciting comments I heard a number of physicians make after they saw our data was that Rocklatan is the first and only product to demonstrate statistically significant IOP lowering in U.S. phase 3 trials compared to the world’s top-selling eye drop, which is latanoprost. What that means is, if you take the top-selling eye drop in the world, Rocklatan was statistically superior to that from an efficacy standpoint,” Mitro said. – by Patricia Nale, ELS
Disclosure: Mitro is the president and chief operating officer of Aerie Pharmaceuticals.