Netarsudil lowers IOP when added to other treatments
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Netarsudil maintained IOP control and provided IOP-lowering efficacy when added to other treatments for patients with open-angle glaucoma or ocular hypertension, according to findings published in Current Medical Research and Opinion.
“Elevated IOP is associated with increased risk for progression of visual field loss in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), and pharmacotherapy to reduce IOP delays progression. The treatment goal for OAG/OHT patients in clinical practice is to lower IOP to the point that subsequent damage to the optic nerve is prevented, without sacrificing safety or convenience,” Fiaz Zamon, MD, ophthalmologist at Houston Eye Associates in Texas, and colleagues wrote.
“The objective of this study was to evaluate the IOP-lowering efficacy of netarsudil in real-world clinical settings when used as monotherapy or concomitantly with other IOP-lowering agents in patients with elevated IOP due to OAG or OHT,” the authors stated.
In a multicenter, prospective, interventional, open-label, phase 4 clinical trial, Zamon and colleagues analyzed data from 261 adults aged 18 and older with OAG or OHT. The study took place at 22 clinical sites in the U.S. for a duration of 12 weeks.
Researchers instructed all participants to use one daily drop of netarsudil ophthalmic solution 0.02% in addition to treatment regimens determined by the investigators. Participants visited the clinical sites three times over 12 weeks: baseline visit (day 0), follow-up visit at week 6 (±7 days) and a final visit at week 12 (±7 days). The primary efficacy endpoint was the percentage reduction from baseline IOP at week 12.
One patient dropped out of the study before taking medication. Of the remaining 260 participants, 99 received netarsudil as monotherapy (mean age, 67.2; 62.6% women; 12.1% Hispanic or Latino; 24% Black; 74% white) and 161 received netarsudil with concomitant therapy (mean age, 67.2; 60.3% women; 5.3% Hispanic or Latino; 29.8% Black; 67.6% white). Before the final visit, 41 additional patients dropped out, including 29 who experienced adverse events.
Of the original 261 participants, 242 received one or more netarsudil doses and had one or more follow-up IOP measurements.
Researchers found that IOP lowered by 16.9% in patients using netarsudil as monotherapy. Additionally, they noticed reductions in mean IOP among subgroups who added netarsudil to a single agent (4.3 ± 2.88 mm Hg; 20.5%) or two or more classes of concomitant therapy (4.5 ± 4.08 mm Hg; 20.9%) and who used netarsudil to replace one or more other drug classes (0.4 ± 2.47 mm Hg; 1.7%).
The limitations of this study include the open-label design, the lack of a comparator group and the potential for improved medication adherence during the study participation prior to enrollment.
“In the real-world treatment of patients with OAG or OHT, netarsudil consistently maintained IOP control when it replaced previous IOP-lowering therapies and provided additional IOP-lowering efficacy when added to other treatments,” Zamon and colleagues wrote. “The introduction of netarsudil treatment as monotherapy or an adjunct to other topical treatments achieved clinically meaningful reductions in IOP, and the replacement of prior agents with netarsudil resulted in IOP control comparable to levels obtainable with established treatments such as prostaglandin analogs.”
The authors concluded that the benefits and safety of netarsudil translate to the real world.
Perspective
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Netarsudil was approved by the FDA in December 2017 for the treatment and management of open angle glaucoma and ocular hypertension. This novel medication provides a once-daily treatment option that lowers IOP by increasing aqueous outflow through the expansion of the juxtacanalicular tissue of the trabecular meshwork and dilation of episcleral vessels. While typically well tolerated, the most noted side effects for this medication are conjunctival hyperemia, corneal verticillata, instillation site pain and conjunctival hemorrhage.
Zaman and colleagues evaluated the IOP lowering efficacy of netarsudil in a real-world setting and found through this multicenter, retrospective analysis that the medication accomplished its IOP lowering goal whether used as monotherapy, in conjunction with other medications or when used as a replacement medication. This study is limited by its open label design and short duration of only 12 weeks.
Netarsudil and the combination therapy of netarsudil-latanoprost are proving to be safe and effective treatment options. Although it’s sometimes hard to change our ways, having additional drops in our arsenal that are well tolerated, easy to use and effective is a luxury that we just can’t ignore.
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Zamon F, et al. Curr Med Res Opin. 2021;doi:10.1080/03007995.2021.1901222.
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