Novel ocular hypotensive drug meets endpoints
Third phase III trial findings add evidence of efficacy and safety
Topline results from data collected after 90 days in the 6-month Rocket 4 phase III clinical trial confirm that netarsudil ophthalmic solution 0.02% (formerly AR-13324; Rhopressa, Aerie Pharmaceuticals) safely and effectively lowers elevated IOP in eyes with ocular hypertension or open-angle glaucoma, said Jason Bacharach, MD.
Rocket 4 randomly assigned about 700 patients 1:1 to once-daily netarsudil or twice-daily timolol maleate 0.5%. Netarsudil met the primary efficacy endpoint, achieving non-inferiority to timolol for lowering IOP in eyes with baseline IOP ranging from >20 to <25 mm Hg.
Netarsudil also met the secondary efficacy endpoints by demonstrating non-inferiority to timolol for lowering IOP in eyes with baseline IOPs ranging from >20 to <27 mm Hg and from >20 to <28 mm Hg.
“The 90-day topline efficacy results from Rocket 4 reiterated the positive findings of Rocket 1 and Rocket 2, the two phase III registration trials. Collectively, the phase III clinical trial program for netarsudil includes a robust number of treated patients, with nearly 2,000 patients dosed,” said Dr. Bacharach, who was an investigator in the Rocket 2 and Rocket 4 trials and a glaucoma specialist in private practice in Sonoma County, CA.
“Approval of this rho kinase/norepinephrine transporter inhibitor would be an exciting and welcome development considering that it would be the first new class of IOP-lowering agents to become available in over 20 years,” he said. “Based on the clinical trial experience, I expect netarsudil will be an important part of our armamentarium, and I am looking forward to using it in the clinical practice.”
Dr. Bacharach observed that in Rocket 4, netarsudil performed better for lowering IOP in eyes with the higher baseline levels than it did in the Rocket 1 and Rocket 2 trials.
In addition, its activity for reducing IOP in eyes with lower starting IOPs distinguishes it from available ocular hypotensive agents. Netarsudil’s broad efficacy is probably explained by its multimodal mechanism of action that involves increased trabecular outflow facility and likely also reduction of episcleral venous pressure, he said.