Well-heeled baby boomers will be able to reach for something besides reading glasses now that Irvine-based AcuFocus Inc. can debut its flagship eye device in the U.S.
The venture-backed startup’s Kamra corneal inlay to treat presbyopia—a condition that affects the eye’s natural ability to focus up close and affects nearly everyone 50 and older—recently got regulatory approval from the Food and Drug Administration.
The condition is traditionally treated with reading glasses.
The Kamra is a fraction of the size of a contact lens and implanted into a patient’s cornea through a pocket created by a femtosecond laser, a device that is more commonly used for cataract and laser vision correction surgeries.
The device has been under development for more than 10 years and on the market for the past five in Europe, where it’s been used in thousands of procedures.
AcuFocus is going after a potentially huge market: Presbyopia affects an estimated 114 million Americans, a number that’s likely to rise in coming years with the aging of baby boomers—the generation born approximately between the late 1940s and mid-1960s.
The company declined to discuss prices for the Kamra, but marketing materials suggest the device and inlay procedure can cost thousands of dollars in Europe, where it has been on the market for five years.
AcuFocus expects to start shipping Kamra in the middle of May to a group of doctors throughout the U.S. who will undergo training and certification in its use.
Kamra is the “first of its kind,” said James Mazzo, the Orange County device veteran who serves as AcuFocus’ chief executive. “In presbyopia, we really don’t have anything. For the ophthalmologist now, for that 45- to 60-year-old, they now have a treatment that can help their patients who are challenged by reading glasses.”
Mazzo said that the overall medical device community benefits from AcuFocus’ approval because of what he described as an “open, cooperative spirit” in how the FDA arrived at its decision to approve Kamra.
“We’ve had our challenges in the past with the FDA. … I will have to tell you I have never seen in my 35 years in this industry a better cooperation with the FDA than in this area,” Mazzo said, praising Drs. Jeffrey Shuren and Malvina Eydelman, a pair of FDA device officials, for their work.
Shuren and Eydelman “beat the timeline” for making a decision on Kamra, according to Mazzo, who said the deadline was in mid-May.
“This clearly shows now that the FDA is in that cooperative mode to have open, candid, very difficult discussions,” Mazzo said.
Venture Capitalists
AcuFocus has backing from venture capitalists, including a $21 million round last year and $65 million in 2011.
The company’s investors include Menlo Park-based Versant Ventures, which has an office in Newport Beach, and San Francisco-based SV Life Sciences.
Mazzo said that AcuFocus’ investors “have been extremely cooperative.”
Bill Link, a Newport Beach-based managing director of Versant who serves as AcuFocus’ chairman, expressed confidence about the device maker’s product and leadership.
“The Kamra technology is one of the most important steps forward in the field of corneal refractive surgery in the past decade,” Link said. “Jim and the AcuFocus team have a strong track record. We had confidence that they would make progress, and obviously they have.”
The Kamra is already sold in 50 countries worldwide and has some 20,000 implants to its credit. Privately held AcuFocus, which doesn’t disclose financial data, also makes the IC-8, an intraocular lens for cataract patients sold overseas, as well as the AcuTarget HD diagnostic and surgical planning instrument.
Mazzo said Kamra would be a “patient pay” product marketed to affluent patients—AcuFocus has no expectations of reimbursements from insurers for the device or procedure.
“We do not anticipate, nor do we desire for this to ever be reimbursed,” Mazzo said.
AcuFocus has 65 workers companywide and plans to hire another five to 10 over the next year. The team includes executives who have worked for Mazzo in the past, including Darin Dixon, director of commercialization for the Americas. Dixon worked for Mazzo when the pair was at Santa Ana-based Advanced Medical Optics Inc., now known as Abbott Medical Optics.
Mazzo said that AcuFocus’ goal is to “continue to build this entity.” He also noted that the company has gained the attention of “large strategics” in the ophthalmic field, including Abbott Medical and Novartis AG unit Alcon Inc.
“We’ve gained that attention—I was very popular” at the American Society of Cataract and Refractive Surgeons’ annual meeting in San Diego earlier this month, Mazzo said.
AcuFocus is “not going to be held hostage” by the notion of attracting a buyer, Mazzo said, although he acknowledged that the company’s backers are likely to eventually seek a sale or initial public offering.
AcuFocus representatives trained some doctors on the Kamra procedure at the meeting, Mazzo added.
AcuFocus is not the only Orange County-based company working on presbyopia. Others include Lake Forest-based ReVision Optics Inc.
AcuFocus was established in 2001 and moved to OC three years later. It grew out of the Innovation Factory LLC, a suburban Atlanta business incubator with ties to Versant.
