■ Aerie Pharmaceuticals announced positive top-line results of its pilot phase 2 study of netarsudil ophthalmic solution in a Japanese-American population. The study was designed to support the potential regulatory submission of netarsudil ophthalmic solution in Japan. Netarsudil ophthalmic solution 0.02% is known by the name Rhopressa in the United States, where it is currently marketed.
This pilot study was initially designed as a larger phase 2 trial to be conducted in the United States, enrolling Japanese subjects and Japanese-American subjects that are within second generation. Due to scarcity of qualified subjects in the United States, the enrollment of this study was limited to approximately 40 subjects across three study arms.
The primary objectives of the study were to evaluate (1) the ocular hypotensive activity of 2 different dose concentrations of netarsudil ophthalmic solution (0.02% and 0.04%) relative to placebo over a 28-day period, for a total of 3 arms all dosed in the evening, and (2) the ocular and systemic safety of netarsudil ophthalmic solution relative to placebo over that period.
The results demonstrated that netarsudil ophthalmic solution 0.02% lowered IOP in mean diurnal IOP by a range of 5.0 to 5.3 mmHg for subjects with an average baseline IOP of 18.3 mmHg. The netarsudil ophthalmic solution 0.04% arm lowered IOP in mean diurnal IOP by a range of 5.2 mmHg to 6.6 mmHg for subjects with average baseline IOP of 20.2 mmHg. The placebo arm lowered IOP in mean diurnal IOP by a range of 2.0 to 2.5 mmHg for subjects with an average baseline pressure of 19.6 mmHg. Both netarsudil arms showed higher levels of IOP reduction as compared to placebo to a statistically significant degree at day 28. The safety findings were consistent with previous netarsudil trials. GP