Netarsudil Ophthalmic Solution (Rhopressa) Launches in United States


The solution to lower elevated intraocular pressure is approved 2 months ahead of the scheduled PDFUA date.

rhopressa, fda, aerie, netarsudil opthalmic solution

Aerie Pharmaceuticals, Inc., has announced that it has launched its netarsudil ophthalmic solution 0.02% (Rhopressa) in the United States, after receiving approval from the US Food and Drug Administration (FDA) in December.

The therapy is now in possession of national and regional US pharmaceutical distributors, and patients will have access to it through local pharmacies across the country, according to Aerie.

“We are pleased to announce the availability in the United States of Rhopressa®, the first new drug class in more than two decades for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension. Our national sales force is fully trained, deployed, and already providing product information and samples to physicians," Vicente Anido Jr., PhD, chairman and chief executive officer of Aerie, said in a statement. "Formulary contracts for commercial insurance coverage in 2018 and Medicare Part D program coverage beginning in 2019 are in the final stages of being executed. In addition, through the availability of a co-pay savings card program, all patients covered by commercial insurance will have immediate access to Rhopressa®. Aerie has also proactively engaged the major e-prescribing platforms to ensure physicians are able to prescribe Rhopressa® electronically for their patients. We look forward to providing additional details as part of our business update during our first-quarter 2018 financial results call scheduled for May 8, 2018."

DEC. 18, 2017: The 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.

This story was originally published on Dec. 18, 2017.

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