Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized...

Area of Science:

• Ophthalmology
• Pharmacology
• Clinical Trials

Background:

• Glaucoma and ocular hypertension require effective intraocular pressure (IOP) management.
• Current monotherapies may not achieve sufficient IOP reduction for all patients.
• Fixed-dose combinations (FDCs) offer potential for improved efficacy and patient compliance.

Purpose of the Study:

• To compare the ocular hypotensive efficacy and safety of a fixed-dose combination (FDC) of netarsudil and latanoprost versus monotherapy with netarsudil or latanoprost.
• To evaluate the superiority of the FDC over its individual components in reducing IOP.

Main Methods:

• A 3-month primary endpoint analysis of a randomized, double-masked, phase 3 clinical trial.
• Adults with open-angle glaucoma or ocular hypertension were randomized to once-daily netarsudil/latanoprost FDC, netarsudil 0.02%, or latanoprost 0.005%.
• Primary efficacy endpoint: mean IOP at 8:00 AM, 10:00 AM, and 4:00 PM at weeks 2, 6, and month 3.

Main Results:

• Netarsudil/latanoprost FDC achieved mean treated IOPs ranging from 14.8-16.2 mm Hg, significantly lower than netarsudil (17.2-19.0 mm Hg) and latanoprost (16.7-17.8 mm Hg).
• The FDC demonstrated statistically and clinically superior IOP reduction (1.8-3.0 mm Hg vs. netarsudil; 1.3-2.5 mm Hg vs. latanoprost) at all time points.
• 43.5% of patients on the FDC achieved mean diurnal IOP ≤15 mm Hg, compared to 22.7% for netarsudil and 24.7% for latanoprost.
• Conjunctival hyperemia was the most frequent ocular adverse event, leading to discontinuation in 7.1% of FDC patients.

Conclusions:

• Once-daily netarsudil/latanoprost FDC demonstrated statistically and clinically superior IOP reductions compared to monotherapy with either agent.
• The FDC offers an effective treatment option for patients with open-angle glaucoma or ocular hypertension.
• The combination therapy showed acceptable ocular safety, with manageable adverse events like conjunctival hyperemia.