A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glauco
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ORIGINAL RESEARCH
A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma James H. Peace . Hayley J. McKee . Casey C. Kopczynski
Received: October 22, 2020 / Accepted: November 11, 2020 The Author(s) 2020
ABSTRACT Introduction: Pharmacotherapy to lower intraocular pressure (IOP) is a mainstay of treatment aimed at delaying progression of visual field loss in ocular hypertension (OHT) and open-angle glaucoma (OAG), but some topical treatments are less effective in controlling IOP at night. Peak IOP may be related to glaucoma progression and can occur outside office hours. A phase 2 study was conducted to evaluate the IOP-lowering efficacy of netarsudil across the diurnal and nocturnal periods. Methods: This was a randomized, doublemasked, single-center, vehicle-controlled, 9-day study. After washout of any prior ocular hypotensive agents, 12 patients with OHT or OAG underwent baseline IOP assessment at 15:00, 18:00, 21:00, 00:00, 03:00, 06:00, 09:00, and 12:00 h on day 1/day 2. Participants were then randomized in a 2:1 ratio to netarsudil ophthalmic solution 0.02% (n = 8) or vehicle (n = 4) for 7 days of self-administered dosing each evening. IOP was assessed at the same time points on day 8/day 9. All measurements were
J. H. Peace (&) United Medical Research Institute, Inglewood, CA, USA e-mail: [email protected] H. J. McKee C. C. Kopczynski Aerie Pharmaceuticals, Inc., Durham, NC, USA
conducted with a Perkins tonometer in habitual positions by day (seated) and at night (supine). Results: Baseline mean 24-h IOP was 22.4 mmHg in the netarsudil group and 22.9 mmHg in the vehicle group. Netarsudil was associated with a reduction in mean nocturnal IOP (measurements at 21:00, 00:00, 03:00, 06:00 h) of 3.5 mmHg, which was significant relative to baseline nocturnal IOP (P \ 0.001) and the reduction in the vehicle group (0.4 mmHg; P \ 0.001 vs. netarsudil). Reduction in mean diurnal IOP with netarsudil (3.5 mmHg) was the same as the nocturnal reduction and statistically significant versus baseline (P \ 0.001) and the vehicle group (0.9 mmHg; P \ 0.01). The magnitude of IOP reductions with netarsudil was consistent at each time point assessed over the 24-h period. No adverse events were reported. Conclusion: Netarsudil exhibited consistent IOP-lowering efficacy over a 24-h period in this short-term study. Trial Registration: Clinicaltrials.gov identifier: NCT02874846.
PLAIN LANGUAGE SUMMARY When pressure inside the eye (called intraocular pressure [IOP]) builds up, a patient may develop a condition known as glaucoma, in which damage to the optic nerve and possibly
Ophthalmol Ther
irreversible vision loss occur. Glaucoma can be preceded in some patients by a condition called ocular hypertension (OHT). Patients with OHT and the most common type of glaucoma (openangle glaucoma [OAG]) should be treated to lower their IOP and decrease the risk for progressive visual loss. Several studies that have evaluated 24-h IOP control have indicated tha
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