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Abstract #81324 Published in IGR 20-3

Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: 3-Month Data From a Randomized Phase 3 Trial

Asrani S; Robin AL; Serle JB; Lewis RA; Usner DW; Kopczynski CC; Heah T;
American Journal of Ophthalmology 2019; 207: 248-257

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PURPOSE: To compare the ocular hypotensive efficacy and safety of a fixed-dose combination (FDC) of the Rho kinase inhibitor netarsudil and latanoprost vs monotherapy with netarsudil or latanoprost. DESIGN: Three-month primary endpoint analysis of a randomized, double-masked, phase 3 clinical trial. METHODS: Adults with open-angle glaucoma or ocular hypertension (unmedicated intraocular pressure [IOP] >20 and <36 mmHg at 8:00 AM) were randomized to receive once-daily (PM) netarsudil/latanoprost FDC, netarsudil 0.02%, or latanoprost 0.005% for up to 12 months. The primary efficacy endpoint was mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at week 2, week 6, and month 3. RESULTS: Mean treated IOP ranged from 14.8-16.2 mmHg for netarsudil/latanoprost FDC, 17.2-19.0 mmHg for netarsudil, and 16.7-17.8 mmHg for latanoprost. Netarsudil/latanoprost FDC met the criteria for superiority to each active component at all 9 time points (all P < .0001), lowering IOP by an additional 1.8-3.0 mmHg vs netarsudil and an additional 1.3-2.5 mmHg vs latanoprost. At month 3, the proportion of patients achieving mean diurnal IOP ≤15 mmHg was 43.5% for netarsudil/latanoprost FDC, 22.7% for netarsudil, and 24.7% for latanoprost. No treatment-related serious adverse event (AE) was reported; treatment-related systemic AEs were minimal. The most frequent ocular AE was conjunctival hyperemia (netarsudil/latanoprost FDC, 53.4%; netarsudil, 41.0%; latanoprost, 14.0%), which led to treatment discontinuation in 7.1% (netarsudil/latanoprost FDC), 4.9% (netarsudil), and 0% (latanoprost) of patients. CONCLUSIONS: Once-daily netarsudil/latanoprost FDC demonstrated IOP reductions that were statistically and clinically superior to netarsudil and latanoprost across all 9 time points through month 3, with acceptable ocular safety.

Duke University School of Medicine, Durham, North Carolina, USA. Electronic address: sanjay.asrani@duke.edu.

Full article

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Classification:

11.13.5 Other (Part of: 11 Medical treatment > 11.13 Combination therapy)

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