AcuFocus Inc., a well-funded Irvine medical device startup, is getting ready to sell a replacement eye lens for fuzzy vision in Europe and Asia.
The company, which has raised $63 million in venture funding, makes the Kamra, a lens implanted in the cornea that treats presbyopia, or the inability to focus up close that comes with aging.
AcuFocus plans to train doctors and start gradual sales of Kamra in Europe and Asia, according to Chief Executive Ed Peterson.
The company, which employs about 25 people now, expects to grow to 40 workers or so in the next 12 months, Peterson said.
AcuFocus plans to hire people for sales, training and customer service.
The company recently brought on Mike Judy, a veteran of Aliso Viejo’s Eyeonics Inc., now part of Rochester, N.Y.-based Bausch & Lomb Inc., and Santa Ana’s Advanced Medical Optics Inc., now Abbott Medical Optics, as its chief commercialization officer.
The company’s lens isn’t approved for use in the U.S.
It could be 18 months to two years before AcuFocus can submit data from a 500-person U.S. clinical trial to a Food and Drug Administration eye device advisory panel, Peterson said.
The advice of the panel could lead to FDA approval.
Peterson declined to say when the company might see U.S. approval for its lens.
Kamra Lens
Kamra weighs less than a gram of salt and contains 8,400 holes that allow nutrients to flow to the cornea.
The lens “is absolutely tiny,” Peterson said.
AcuFocus is pushing its lens as an alternative to traditional treatments for presbyopia, such as reading glasses. It’s one of several companies looking to come up with a surgical fix.
Kamra is implanted in the eye through a flap cut into the cornea with a femtosecond laser device, similar to Lasik vision-correction surgery. It can be used in patients who already have had Lasik.
AcuFocus hasn’t set a price for Kamra, which is targeted at patients ages 45 to 60. Insurers aren’t expected to cover the lens, Peterson said.
The chief executive had the lenses implanted into his own eyes in Europe.
“I wanted to see what it was actually doing,” he said.
Peterson, a bicyclist who spent six days in Europe riding in front of the Tour de France last month, said he can read his BlackBerry and e-mails with the lenses and doesn’t have to use reading glasses.
AcuFocus has had European regulatory clearance since 2005 but has waited to start sales there. The company didn’t want to start selling abroad too soon before the prospect of U.S. approval, Peterson said.
Investors
Investors in the company include Menlo Park-based Versant Venture Management LLC, which has a Newport Beach office, SV Life Sciences of San Francisco and Accuitive Medical Ventures LLC of Atlanta. It’s also received funding from Carlyle Group LLC, a Washington, D.C.-based private equity investor, and Bausch & Lomb, which made an undisclosed investment in AcuFocus three years ago.
William Link, a locally based Versant managing director and AcuFocus’ chairman, has said the company’s lens has merit because of the size of its potential market.
“For any of us who are over 45 or 50, we realize we need help in reading and seeing intermediate,” he said.
Whether AcuFocus would need more investment “remains unanswered,” Peterson said.
Competition
AcuFocus could become part of a larger eye device company because potential buyers “are all interested in an answer for presbyopia,” he said.
The company is one of several local startups going after presbyopia.
The executives from those companies “all know each other well (and) we all speak frequently,” Peterson said.
Lens entrepreneurs are “all for each other, even if you have a competitive product. No one product is going to serve every population,” he said.
ReVision Optics Inc. of Lake Forest is working on a lens to treat the condition. Irvine’s Visiogen Inc., now part of Abbott Medical Optics, developed the Synchrony lens for treating presbyopia.
AcuFocus was founded in 2001 and moved to Orange County in 2004.
It grew out of a suburban Atlanta business incubator called Innovation Factory LLC, which has ties to Versant. Peterson was Innovation Factory’s vice president of business development when AcuFocus was started.
