03.12.19

Aerie Pharmaceuticals Receives FDA Approval of Rocklatan for Reduction of IOP

Source: Aerie Pharmaceuticals

Aerie Pharmaceuticals announced that the FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% to reduce elevated IOP in patients with open-angle glaucoma or ocular hypertension.

Rocklatan is a once-daily eye drop that is a fixed-dose combination of latanoprost, the most widely-prescribed prostaglandin analog (PGA), and netarsudil, the active ingredient in Rhopressa (netarsudil ophthalmic solution) 0.02%, a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork. The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension. Rhopressa works by restoring outflow through the trabecular meshwork, while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway.

Aerie launched Rhopressa in the United States in April 2018. The company plans to launch Rocklatan in the United States in the second quarter of 2019.

In an exclusive interview with Eyewire News, Vicente Anido, Jr., PhD, chairman and chief executive officer at Aerie, discussed how he believes Rocklatan and Rhopressa will coexist to  provide a broad therapeutic franchise.

“We do think that both products [Rhopressa and Rocklatan] are going to do very well in the marketplace. There will always be a little bit of attrition to the Rhopressa business as a result of having Rocklatan available, but we think that the positioning—based on the discussion we’ve had with physicians—is as follows: We think that Rocklatan will be the first drug [physicians] think about for the majority of their patients that have [elevated] intraocular pressure or glaucoma. It will be their primary position, if you will, in terms of what drug they want to use. But we also know that physicians don’t all like lantanoprost as their favorite prostaglandin. Some of them like Lumigan (bimatoprost; Allergan), and Travatan (Travatan Z, travoprost; Alcon), etc., and they really don’t want to give those up and switch over necessarily to a lantanoprost-containing combination. So we think that Rhopressa will play very, very well as a product that will be added to the other prostaglandins,” Dr. Anido said.

“There are a lot of patients who either don’t respond to prostaglandins, or who are very concerned about the permanent cosmetic changes that are caused by the prostaglandins. I think about things like the long eye lashes or the loss of the fatty tissue around the eye, etc., or the changes in iris color. And so as a result, we think that there’s going to be also a pretty good-size opportunity for Rhopressa since it’s the only other product available once-a-day to be used in those kinds of patients. The ones who are simply not responsive to prostaglandins,” Dr. Anido added.

The FDA approval of Rocklatan is based on data from two phase 3 registration trials, MERCURY 1 and MERCURY 2. In these studies, Rocklatan achieved its 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. More than 60% of patients taking Rocklatan in the two MERCURY studies achieved an IOP reduction of 30% or more, a frequency that was nearly twice that achieved by participants taking latanoprost alone. Rocklatan also helped more patients get to low target pressures. Nearly twice as many patients taking Rocklatan reached 16 mmHg or lower and nearly three times as many reached 14 mmHg or lower compared to latanoprost.

In the two MERCURY studies, Rocklatan treatment was associated with generally mild and tolerable ocular adverse events, with minimal systemic side effects. The most common ocular adverse event in controlled clinical studies with Rocklatan was conjunctival hyperemia. Ninety percent of patients who experienced hyperemia reported it as mild and 5% discontinued because of it. Other common ocular adverse effects reported in the studies include instillation site pain, corneal verticillata, and conjunctival hemorrhage.

Aerie is working on securing favorable reimbursement for our products, Dr. Anido said, with Rhopressa now receiving broad commercial and Medicare Part D coverage, and Rocklatan already under review by major payers.

A link to the full product label is available on the Aerie website at http://investors.aeriepharma.com.

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