Researchers found in two randomized, double-masked clinical trials that once-daily dosing of netarsudil 0.02% was well tolerated for the treatment of ocular hypertension and open-angle glaucoma and non-inferior to timolol.
A total of 1,167 patients were enrolled in the ROCKET-1 and ROCKET-2 clinical trials and randomized to receive netarsudil 0.02% ophthalmic solution (Rhopressa, Aerie Pharmaceuticals) once daily, timolol twice daily and netarsudil 0.02% twice daily (ROCKET-2 only).
Once-daily netarsudil showed clinically and statistically significant reductions from baseline IOP and was non-inferior to timolol. Researchers also found that netarsudil twice daily was non-inferior to timolol but was not as well tolerated as once-daily dosing.
All three treatment groups produced statistically significant mean IOP reductions from baseline over the 3-month assessment.
Mean IOP in the netarsudil once-daily group ranged from: 16.7 mm Hg to 18.2 mm Hg; in the twice daily group: 15.7 mm Hg to 17.6 mmHg; and in the timolol group: 16.6 mm Hg to 17.7 mm Hg.
Adverse events in patients treated with once-daily netarsudil were mainly non-serious, generally mild in intensity and resulted in patient discontinuation from the study in 10% to 12% of participants, researchers wrote. The twice-daily dosing of netarsudil led to discontinuation in 30% of patients.
The most frequently reported adverse events were conjunctival hyperemia and conjunctival hemorrhage.
Researchers unexpectedly found that once-daily netarsudil 0.02% did not meet the criteria for non-inferiority to twice-daily timolol in the primary efficacy population of patients with maximum baseline IOP of less than 27 mm Hg. They are testing a hypothesis for this result in a follow-up phase 3 study, ROCKET-4, which includes subjects with baseline unmedicated IOP from greater than 20 mm Hg to less than 30 mm Hg. –by Abigail Sutton
: The research was sponsored by Aerie Pharmaceuticals. Serle is a member of the Aerie Pharmaceuticals scientific advisory board and is a consultant to Bausch + Lomb and Allergan and receives research support from Allergan, Inotek and Ocular Therapeutix and is a stockholder in Aerie Pharmaceuticals. Please see the full study for all remaining authors’ financial disclosures.