Mark another entry in Orange County’s growing roster of eye-care companies.
PresbiTech Inc., the U.S. affiliate of Netherlands-based medical device maker Presbia Coöperatief U.A., has opened an office and manufacturing facility at 8845 Irvine Center Drive in Irvine. The company recently took 9,000 square feet of space in a move from a previous, smaller headquarters in Los Angeles.
Presbia makes medical devices to fight presbyopia, an aging condition that hampers the ability to focus close up. An estimated 73 million Americans have the condition.
“We believe we will be able to recruit talent and professional people into our industry from the area [because] there are a bunch of companies,” Chief Executive Zohar Loshitzer said.
PresbiTech’s chief technology officer, Vladimir Feingold, lives in Orange County, Loshitzer noted. Presbia, which established its local office recently, expects to create 15 to 20 local jobs.
The company’s main product is the Presbia Flexivue Microlens. Flexivue is 3 millimeters in diameter and is implanted into a patient’s eye via a femtosecond laser device.
“We create the pocket in the cornea and designate the lens based on the power need, Loshitzer said. “That’s what’s unique about it.”
Flexivue also is reversible, and that sets it apart from other treatments. “The lens can be explanted and the vision restored to the previous condition,” Loshitzer said.
Flexivue received European regulatory clearance three years ago and is sold in Europe and Latin America.
Loshitzer declined to disclose Presbia’s revenue. The company is still a few years away from U.S. sales.
FDA
Presbia has applied for an investigational device exemption with the Food and Drug Administration and will then conduct clinical trials, Loshitzer said. He added that an approval could come in 2015 or 2016.
The company hopes to sell the device to laser eye-surgery centers with large patient volumes upon FDA approval, Loshitzer said. The company has been making such centers aware of Flexivue through presentations at eye-surgery trade shows.
“[Centers’ patients] become presbyopic with age, so they have [our target] customer base,” Loshitzer said.
“Significant Progress”
He added that PresbiTech’s move to OC and expansion of its U.S. operations “demonstrates the significant progress Presbia is making in the commercialization of the Presbia Flexivue Microlens.”
Flexivue will be targeted toward patients seeking to avoid reading glasses, and PresbiTech doesn’t expect insurance coverage of its implants.
Cluster
OC is home to a cluster of startup operations that also are involved in presbyopia treatment:
• Irvine-based AcuFocus Inc. makes a cornea implant called the Karma and received a $65 million investment last year to expand commercially in new and existing markets. Investors included Medtronic Inc., a Minnesota device maker with about 700 workers in Orange County; Rochester, N.Y.-based Bausch & Lomb Inc., which has an eye surgery hub in Aliso Viejo; and Menlo Park-based Versant Venture Management LLC, which has a Newport Beach office.
• ReVision Optics Inc. in Lake Forest makes the Raindrop corneal inlay lens, which is in third-phase FDA clinical trials and is sold in Europe to treat presbyopia. ReVision has raised over $70 million in venture funding.
• Abbott Medical Optics Inc.—a Santa Ana-based unit of Chicago-based Abbott Laboratories Inc.—acquired Irvine-based Visiogen Inc. and its Synchrony presbyopia-correction lens three years ago. Synchrony remains in development.
