A well-funded eye device startup in Aliso Viejo is making regulatory progress in its quest to bring a new product to treat glaucoma to the U.S. market.
AqueSys Inc. said last week that it has completed enrollment in an investigational study of its Xen 45 gel stent. The company will collect 12 months of data on patients enrolled in the study. AqueSys also recently received a license from regulators in Canada to sell the product there.
Glaucoma is an eye disease that affects roughly 65 million people around the world and is a major cause of blindness. AqueSys’ Xen gel stent is a miniscule, minimally invasive implant for treating forms of the disease that are resistant to traditional therapies, such as drugs and surgery.
Xen is intended to “effectively treat [glaucoma patients] in a safe manner after they’ve already failed medical and/or previous surgical glaucoma treatments,” Chief Executive Ron Bache said.
“You have to be able to give them efficacy and relief—it’s a tall order, but we’ve been able to establish that we can do it well,” Bache said. “We think we have the answer to a very large disease.”
Bache estimates that Xen could get Food and Drug Administration clearance in late 2016.
AqueSys will be entering a large market if Xen is approved. The company pegs the early drug and surgery market for treating glaucoma at about $5 billion annually.
That’s just a fraction of the potential market, according to Bache, who said only 25% of glaucoma is diagnosed worldwide.
AqueSys is developing Xen with a solid war chest—it’s raised $77 million in its nine-year history. Its last large round of funding came in January 2014, when it raised $43.6 million in a fourth round.
“We’re well-funded for years,” Bache said.
Carlyle Group of Washington, D.C.; Longitude Capital of Menlo Park and Greenwich, Conn., and Rho Ventures, which has offices in New York, Menlo Park and Montreal, are among AqueSys’ investors.
Rivals
AqueSys is gearing up to compete in a market with some big rivals.
Irvine-based Allergan Inc., which is being acquired by Actavis PLC in a deal currently valued at $71.5 billion, has several glaucoma drugs in its lineup, including Alphagan P, Lumigan, Combigan and Ganfort.
Switzerland-based Alcon Inc., which has some 765 local workers, sells the Travatan Z and Azopt glaucoma drugs and the Ex-Press, a surgical device that lowers pressure in the eye.
AqueSys plans to remain independent instead of positioning itself for an acquisition.
“We’re focused on executing the business … a liquidity event is not our primary focus,” Bache said. “That will come by us executing with excellence.”
AqueSys was founded in 2006 and now has about 30 workers. It has sales overseas, but Bache declined to give specific revenue figures.
The company is now using “the very best distributors” for Europe and Canada, Bache said.
AqueSys will have a direct sales force to serve ophthalmic surgeons in the U.S. once Xen reaches the market here.
AMO Ties
AqueSys Chief Executive Bache has spent more than 20 years in the business and has big ophthalmic device company credentials. He was with Santa Ana-based Advanced Medical Optics Inc. when Allergan spun that business off in 2002.
Chicago-based Abbott Laboratories acquired Advanced Medical in 2009, and the company is now known as Abbott Medical Optics.
Bache participated in several deals that built up Advanced Medical’s surgery unit. The company spent $1.3 billion for Santa Clara-based Visx Inc. in 2005 and $808 million for Irvine-based IntraLase Corp. in 2007.
Bache joined AqueSys in 2009 when Duluth, Ga.-based Innovation Factory, an investment firm that founded and incubated the startup, brought him on board.
He moved AqueSys to Orange County because of “access to critical human resources,” he said. “The potential for talent around here in ophthalmology is the best in the world.”
