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Netarsudil, latanoprost together more effective for glaucoma than separately
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The combination of netarsudil and latanoprost proved to be superior in treating glaucoma compared with the use of the two drugs by themselves, according to findings published in the American Journal of Ophthalmology.
Sanjay Asrani, MD, MBBS, and colleagues compared the ocular hypotensive efficacy and safety of a fixed-dose combination of the Rho kinase inhibitor netarsudil 0.02% (Rhopressa, Aerie Pharmaceuticals) and latanoprost vs. the use of netarsudil or latanoprost alone.
“Several clinical studies support the general conclusion that greater reductions in IOP are associated with delays in progression in patients with glaucoma or ocular hypertension,” Asrani, a professor of ophthalmology at the Duke University School of Medicine, and colleagues wrote. “IOP can be reduced using topical ocular hypotensive medications; however, for many patients, monotherapy is insufficient to achieve target IOP, necessitating the use of multiple medications.”
The researchers conducted a 3-month primary analysis of a randomized double-masked, phase 3 clinical trial.
Asrani and colleagues stratified adults with open-angle glaucoma or ocular hypertension into groups receiving the fixed-dose combination of netarsudil and latanoprost once daily (n = 238), netarsudil 0.02% (n = 244) or latanoprost 0.05% (n = 236) for up to 12 months. The primary efficacy endpoint was mean IOP at 8 a.m., 10 a.m. and 4 p.m. at 2 weeks, 6 weeks and 3 months.
The researchers found that the mean treated IOP for the fixed-dose combination group ranged from 14.8 mm Hg to 16.2 mm Hg, while the netarsudil group had a mean treated IOP range between 17.2 mm Hg and 19 mm Hg. The mean treated IOP range for latanoprost was 16.7 mm Hg to 17.8 mm Hg.
Asrani and colleagues wrote that the netarsudil and latanoprost fixed-dose combination met superiority criteria in all nine timepoints (P < .0001). The fixed-dose combination led to additional decreases in IOP compared with both netarsudil (additional decrease of 1.8 mm Hg to 3 mm Hg) and latanoprost alone (additional decrease of 1.3 mm Hg to 2.5 mm Hg).
At the 3-month mark, 43.5% of patients in the fixed-dose group achieved a mean diurnal IOP of 15 mm Hg or less compared with 22.7% of the netarsudil only group and 24.7% of the latanoprost only group, the researchers wrote.
The most frequent ocular adverse event was conjunctival hyperemia, which was seen in 53.4% of the fixed-dose combination group, 41% of the netarsudil group and 14% of the latanoprost group, Asrani and colleagues wrote. The conjunctival hyperemia led to the discontinuation of treatment in 7.1% patients in the fixed-dose combination group, 4.9% of the netarsudil group and none in the latanoprost group. – by Earl Holland Jr.
Disclosures: Asrani reports receiving consulting fees from Aerie Pharmaceuticals, Camras Vision, Noveome Biotherapeutics and Regenex Bio. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Mark Eltis, OD, FAAO
Decreasing IOP is currently the only way to preserve vision for glaucoma sufferers. Current medications achieve this result by either decreasing aqueous outflow via trabecular or uveoscleral pathways or decreasing aqueous production. An ideal medical solution would provide maximum protection against disease progression along with convenient dosing and minimal side effects. Unfortunately, the simplest therapy, monotherapy, often fails to achieve our IOP-lowering goals.
Prostaglandin analogs and Rho-associated kinase inhibitors have complementary mechanisms of action. Not surprisingly, these drugs have a synergistic effect. They are two of the most potent IOP-reducing medications currently available, and both also offer patients convenient once daily dosing. These drugs are currently available commercially in the fixed combination preparation Rocklatan (netarsudil 0.02%/latanoprost 0.005% ophthalmic solution, Aerie Pharmaceuticals). This combination can be significant, as every 1 mm Hg decrease in IOP can result in a 10% reduction in the risk of glaucomatous progression (Early Manifest Glaucoma Trial, Heijl et al.). While I’m excited to have a new IOP-lowering preparation, the incidence of hyperemia with the combination in this new study was four times greater than with a prostaglandin analog alone. In our zeal to minimize IOP we must be mindful of side effects that could cause patients to abandon the treatment altogether.
Reference:
Heijl A, et al. Arch Ophthalmol. 2002;doi:10.1001/archopht.120.10.1268.
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