The US Food and Drug Administration (FDA) has approved a once-daily treatment with netarsudil and latanoprost ophthalmic solution (Rocklatan, Aerie Pharmaceuticals) to decrease elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, the company has announced.
Rocklatan is the first and only once-daily, fixed-dose combination of a prostaglandin analog (latanoprost) and the first-in-class rho-associated protein kinase (ROCK) inhibitor (netarsudil), according to the company.
Netarsudil is the active ingredient in Rhopressa (Aerie Pharmaceuticals), which was approved by the FDA in February 2018 as a once-daily treatment for open-angle glaucoma or ocular hypertension. Netarsudil targets the trabecular outflow pathway, countering the stiffening and contraction of the meshwork that elevates ocular pressure.
FDA approval of the netarsudil/latanoprost ophthalmic solution was supported by data from two phase 3 clinical trials known as MERCURY 1 and MERCURY 2.
In both studies, the drug achieved the primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, "demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured time point," the company said.
More than 60% of patients using the netarsudil/latanoprost ophthalmic solution in the two studies achieved an IOP reduction of 30% or more, a frequency that was nearly twice that achieved by participants taking latanoprost alone.
The netarsudil/latanoprost combination product also helped more patients get to "low target" pressures, the company said, noting that nearly twice as many patients using it reached 16 mm Hg or lower and nearly three times as many reached 14 mm Hg or lower compared with latanoprost.
The netarsudil/latanoprost ophthalmic solution was associated with generally mild and tolerable ocular adverse events, according to the company, with minimal systemic side effects. The most common ocular adverse event was conjunctival hyperemia. Most patients who experienced hyperemia reported it as mild; 5% stopped using the eye drops because of it. Other common ocular adverse effects reported in the studies include instillation site pain, corneal verticillata, and conjunctival hemorrhage.
The company said it plans to launch the netarsudil/latanoprost ophthalmic solution in the second quarter of 2019.
Tad Heitmann, head of communications for Aerie Pharmaceuticals, told Medscape Medical News that the company has not announced a price for Rocklatan, "but you can expect a small premium to Rhopressa. We have guided to a net price of about $100 per bottle for Rhopressa and about $110-115 per bottle for Rocklatan."
The National Eye Institute estimates that more than 2.7 million people in the United States have glaucoma, a number expected to reach 4.3 million by 2030.
Cite this: FDA OKs Rocklatan, a New Once-Daily Eye Drop for Glaucoma - Medscape - Mar 13, 2019.