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Janet B Serle, Malik Kahook, Richard A Lewis, Theresa G. H. Heah, Nancy Ramirez-Davis, Casey Kopczynski, Dale W Usner, Gary Novack; Long-term Safety and Ocular Hypotensive Efficacy of Netarsudil Ophthalmic Solution: The ROCKET-2 Study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1242. doi: https://doi.org/.
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Previously, we reported 3-month results of the ROCKET-1 (R1) and ROCKET-2 (R2) Phase 3 studies of netarsudil, a new topical inhibitor of Rho kinase and norepinephrine transporter, in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) (Serle JB et al. AJO in press). In this report, we extend that report to include safety observations from the full 12-months of treatment in R2.
The 12-month R2 study was a double-masked, randomized, multi-center, parallel-group study comparing netarsudil ophthalmic solution, 0.02% to timolol maleate ophthalmic solution, 0.5% in 756 patients with elevated IOP. Netarsudil was dosed QD PM or BID and timolol was dosed BID. Following the primary efficacy endpoint at 3 months, patients were seen quarterly at 08:00 hours.
For subjects with maximum baseline IOP < 25 mmHg, mean IOP at 08:00 hours ranged from 17.9 to 18.8 mmHg for netarsudil dosed QD, demonstrating persistence of ocular hypotensive efficacy over the 12 months of the study.Adverse events (AE) in patients treated with netarsudil QD were predominantly non-serious, generally mild in intensity, and resulted in discontinuation from the study in 12% of patients over three months, and 28% over 12 months. In contrast, AEs associated with twice-daily dosing of netarsudil led to discontinuation in 52% of patients, and with timolol, 6%. The most frequently reported AEs were ocular, with the most frequent ocular AE being conjunctival hyperemia with an incidence of 61% for netarsudil QD, 66% for netarsudil BID, and 14% for timolol. The next most frequent AEs were corneal deposits (corneal verticillata), with an incidence of 25%, 25%, and 1%, respectively and conjunctival hemorrhage (typically petechial) with an incidence of 20%, 19% and 1%, respectively. All three AEs were generally scored as mild with conjunctival hyperemia and/or hemorrhage appearing sporadically throughout the 12 months.
In this randomized, double-masked trial, once-daily dosing of netarsudil 0.02% was found to be effective, consistently lowering IOP through 12-months, and well-tolerated in patients with OAG and OHT. The novel pharmacology and aqueous humor dynamic effects of this molecule suggest it may be a first line treatment option and a potentially beneficial adjunct to the other classes of compounds used to treat glaucoma.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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