Netarsudil ophthalmic solution shows positive phase 2 results in Japanese-American population

A pilot phase 2 trial showed Aerie Pharmaceuticals’ netarsudil ophthalmic solution lowered IOP in a Japanese-American population, according to a press release.

Two dose concentrations of netarsudil ophthalmic solution, known as Rhopressa (netarsudil ophthalmic solution 0.02%) in the United States, were studied in 40 Japanese-American subjects in accordance with the requirements of Japan’s Pharmaceuticals and Medical Devices Agency to support potential regulatory submission, the release said.

Patients with an average baseline IOP of 18.3 mm Hg received netarsudil ophthalmic solution 0.02% and experienced a mean diurnal IOP reduction of 5 mm Hg to 5.3 mm Hg, while those with an average baseline of 20.2 mm Hg received netarsudil ophthalmic solution 0.04% and had a reduction between 5.2 mm Hg and 6.6 mm Hg. The trial’s placebo arm, which had an average baseline pressure of 19.6 mm Hg, had an IOP reduction of 2 mm Hg to 2.5 mm Hg. The IOP reduction in the two study arms was statistically significant compared with the placebo arm.

“These pilot study results, while representing a relatively low number of subjects, may hold great promise for the Japanese glaucoma market,” Vicente Anido Jr., PhD, Aerie’s chairman and CEO, said in the release. “Studies in Japan have shown that Japanese glaucoma patients experience IOPs that are generally lower than those experienced in the United States and Europe, essentially what is known as low-tension glaucoma. Also, the netarsudil IOP-reducing performance in this study compares favorably to that of a twice-daily Rho kinase inhibitor currently marketed in Japan.”

Aerie plans a phase 2 clinical trial in Japan in the first quarter of 2019 that will include a 0.01% concentration of netarsudil.

A pilot phase 2 trial showed Aerie Pharmaceuticals’ netarsudil ophthalmic solution lowered IOP in a Japanese-American population, according to a press release.

Two dose concentrations of netarsudil ophthalmic solution, known as Rhopressa (netarsudil ophthalmic solution 0.02%) in the United States, were studied in 40 Japanese-American subjects in accordance with the requirements of Japan’s Pharmaceuticals and Medical Devices Agency to support potential regulatory submission, the release said.

Patients with an average baseline IOP of 18.3 mm Hg received netarsudil ophthalmic solution 0.02% and experienced a mean diurnal IOP reduction of 5 mm Hg to 5.3 mm Hg, while those with an average baseline of 20.2 mm Hg received netarsudil ophthalmic solution 0.04% and had a reduction between 5.2 mm Hg and 6.6 mm Hg. The trial’s placebo arm, which had an average baseline pressure of 19.6 mm Hg, had an IOP reduction of 2 mm Hg to 2.5 mm Hg. The IOP reduction in the two study arms was statistically significant compared with the placebo arm.

“These pilot study results, while representing a relatively low number of subjects, may hold great promise for the Japanese glaucoma market,” Vicente Anido Jr., PhD, Aerie’s chairman and CEO, said in the release. “Studies in Japan have shown that Japanese glaucoma patients experience IOPs that are generally lower than those experienced in the United States and Europe, essentially what is known as low-tension glaucoma. Also, the netarsudil IOP-reducing performance in this study compares favorably to that of a twice-daily Rho kinase inhibitor currently marketed in Japan.”

Aerie plans a phase 2 clinical trial in Japan in the first quarter of 2019 that will include a 0.01% concentration of netarsudil.