Aerie Pharmaceuticals Inc. has set its sights on a potentially huge target: helping glaucoma patients reduce the risk of blindness.
The Bedminster biotech, which recently completed a $68 million initial public offering intended largely to finance late-stage clinical trials for its lead product, is doing so by building a pipeline of therapies designed to reduce nerve damage resulting from glaucoma.
“The biggest fear is going blind,” Aerie Chief Financial Officer Richard Rubino said. “It's one of the biggest fears we have. If you can stop the progression of the disease by taking a convenient one-drop-a-day that has been shown heretofore to be safe — there are more studies to do obviously — I think patients will certainly gravitate toward the drug.”
Glaucoma, the second leading cause of blindness after cataracts, causes damage to the eye's optic nerve. It is associated with increased pressure inside the eye — called intraocular pressure — resulting from fluid buildup. Glaucoma can lead to blindness if untreated. The condition often worsens with age.
Aerie is attacking the problem with a distinct technology it believes will give it a competitive advantage. Rubino uses a plumbing analogy to illustrate the point.
Existing glaucoma treatments mostly relieve intraocular pressure by decreasing fluid production. Rubino said Aerie's lead product, AR-13324, seeks to go beyond that by targeting the diseased tissue that causes drainage problems in the first place. Plus, the eye drop would be taken once daily, whereas most competing treatments are taken two to three times a day.
AR-13324 treats an area of tissue known as the trabecular meshwork, the eye's primary draining system near the base of the cornea. When the tissue is damaged, it fails to drain effectively and, like any bad plumbing system, creates backup and increases pressure.
Using patented technology based on the discovery of certain molecules, Aerie seeks to relax the damaged tissue while also reducing fluid production, restoring a more normal flow.
“There is no drug that targets the diseased tissue,” said Dr. David Epstein, chairman of Duke University's ophthalmology department and co-founder of Aerie. “Back in medical school, the first rule is you identify the diseased tissue and intervene there.”
Aerie plans to begin Phase III, or late-stage trials, of AR-13324 by mid-year. About 1,200 patients will be enrolled and safety and efficacy data is expected by mid-2015. The company hopes to file a new drug application to the Food and Drug Administration in 2016. Aerie's second product, PG-324, which expands upon the first, is about a year behind that schedule.
The pre-revenue company estimates $4.5 billion is spent annually on glaucoma treatments in the United States, Europe and Japan, Aerie's target regions. If AR-13324 gets approval, the company anticipates hiring its own sales force of about 100 in the United States.
While success hinges on clinical trials, investors are taking notice. Aerie's stock is up 70 percent since its October IPO of $10.
“The level of interest is really remarkable,” Rubino said. “The level of interest on the part of clinicians, the investor base. Investors are always looking for innovation. The potential is very big.”
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