FDA Approves Netarsudil Ophthalmic Solution (Rhopressa, Aerie)

DECEMBER 18, 2017
Jenna Payesko
rhopressa, fda, aerie, netarsudil opthalmic solutionThe US Food and Drug Administration (FDA) has approved netarsudil ophthalmic solution 0.02% (Rhopressa) to lower elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, announced Aerie Pharmaceuticals.

The novel, once-daily eye drop is approved for the lowering of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

“The clinical community has been waiting 21 years for a new category of eye drops to enhance medical therapy for their patients with glaucoma,” Richard A. Lewis, MD, chief medical officer, Aerie Pharmaceuticals, practicing glaucoma specialist, Sacramento Eye Consultants, told MD Magazine. “Once-daily Rhopressa represents the first new FDA-approved class of drug – Rho kinase, or ROCK, inhibitors – to treat elevated intraocular pressure (IOP) since the mid-1990s."

The FDA approval was made 2 months ahead of the scheduled Prescription Drug User Fee Act (PDUFA) date of Feb. 28, 2018.

"Rhopressa is believed to work differently than other widely-used IOP lowering medications by improving outflow of aqueous humor through the trabecular meshwork, the normal drainage pathway in the eye," Lewis added. "It has been shown to have an IOP-lowering effect with minimal systemic adverse events and no contraindications. Topical adverse events, when present, were typically mild in the majority of patients. This profile gives Rhopressa the potential to be used effectively alone or with other medications to help patients reach and maintain their target pressures.”

An expert advisory committee voted 9-to-1 in favor of the safety of the solution and 10-0 in favor of its efficacy in October.

The decision was based on data from Rhopressa’s clinical trials, Rocket 1 and Rocket 1.

The phase 3 clinical trials compared the once daily solution to timolol twice daily solution, and showed that Rhopressa demonstrated a consistent level of lowering intraocular pressure from day 90 through 12 months. The average diurnal intraocular pressure in the solution arm was 21.4 mmHg and decreased to 17.4 mmHg at day 90 — with changes beginning as early as week 2.

The most common adverse effect is conjunctival hyperemia (53%), while other reactions, approximately 20% include corneal verticillata, instillation site pain and conjunctival hemorrhage.

“The approval of once-daily of Rhopressa represents the single greatest achievement in Aerie’s history to date, and represents exciting news for patients with open-angle glaucoma or ocular hypertension, and physicians,” Vicente Anido, Jr., PhD, chairman and chief executive officer, Aerie, said in a statement.

Aerie plans to launch Rhopressa by mid-second quarter of 2018.

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