Two months ahead of the PDUFA date scheduled for February 28, 2018, the Food and Drug Administration (FDA) approved Aerie Pharmaceuticals’ (AERI) ophthalmic solution) 0.02% Rhopressa® (netarsudil for the lowering of elevated intraocular pressure (IOP) in open-angle glaucoma.
Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie said that the firm will hire a sales force of 100 sales representatives early in the first quarter of 2018, and plans the launch by a mid-second quarter of 2018.
The firm’s goal during 2018, he said, is to gain formulary coverage for commercial plans, which represent approximately half of the U.S. market. The other half of the U.S. market is covered by Medicare Part D. He expects formulary presence for this market to commence in January 2019.”
About the firm’s product Roclatan™, Dr. Anido said, a new drug application to the FDA will be filed in the second quarter 2018.”
Rhopressa® (netarsudil) ophthalmic solution 0.02%, is a novel once-daily eye drop for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma. The drug is believed to reduce IOP by increasing the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye.
The approval of Rhopressa® was expected but the earlier approval was not. This early approval could be a telling sign that the FDA appreciates the novel mechanism of action of the product and the trial results. The approval is thrilling news for Aerie as it transitions it from development-stage into a revenue-generating firm, which is expected to facilitate its future projects.
The nearest of Aerie’s future accomplishment will be the filing for approval of its second Glaucoma product Roclatan™, in the second half of 2018.
Prohost selected Aerie for its Portfolio on 11/16/2016, at $41.58. The stock is trading today around $60.10 with a market cap of $2.20.
We take advantage to describe Aerie’s second in line product, Roclatan.
Aerie’s Next Program
Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% is a once-daily eye drop that combines Rhopressa™ ophthalmic solution with latanoprost, a widely-prescribed PGA.
Preclinical studies and clinical trials to date demonstrate that the drug could be the first to lower IOP through all known mechanisms:
(i) increasing fluid outflow through the trabecular meshwork, the eye’s primary drain,
(ii) increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain,
(iii) potentially reducing fluid production in the eye, and (iv) reducing episcleral venous pressure
All we can say at this stage is that Roclatan™ ophthalmic solution has the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product.
MERCURY 1 Trial: Demonstrated that Roclatan was statistically superior to each of its components with IOP-lowering beyond the comparators in the range of 1 to 3 mmHg.
MERCURY 2 Trial: Achieved its primary efficacy endpoint demonstrating statistical superiority beyond the comparators in the range of 1 to 3 mmHg.
MERCURY 3 Trial: This trial started in Europe in the third quarter of 2017. According to Aerie, Mercury 3 is not necessary for approval in the U.S., but rather to facilitate regulatory approval and commercialization in Europe. The trial compares Roclatan™ to Ganfort®, a fixed-dose combination product of bimatoprost and timolol marketed in Europe.
If successful, Aerie believes it would improve its commercialization prospects in Europe.
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