Another Orange County device maker wants an aging U.S. population to see better.
Presbia PLC—chartered in Dublin, Ireland, but with senior executives, most of its 46 employees, and manufacturing in Irvine—makes an implantable corneal lens to treat presbyopia, an age-related condition that hinders the eye’s ability to see objects close up.
It emerged from the shadows in OC with an initial public offering in early 2015 that raised $42 million, and a recent rights offering in March to current shareholders added another roughly $11 million.
The company’s Flexivue Microlens is in phase two clinical trials in the U.S. and has CE Mark approval that allows it to be sold in Europe, South Korea and Australia.
It’s about two years away from potential Food and Drug Administration approval, but Chief Financial Officer Jarett Fenton called a ramp-up in the company’s efforts “inevitable … no matter how we choose to commercialize.”
Presbia had been legally based here but moved its headquarters to Dublin after it went public.
Chief Executive Todd Cooper and Fenton said the company keeps its administration and the bulk of its employees here because of the local “healthcare talent … specifically in ophthalmic,” Fenton said.
This blessing also makes for a curse, since two of Presbia’s main competitors are also in OC: AcuFocus Inc. in Irvine and Revision Optics Inc. in Lake Forest.
Seeing Triple
AcuFocus and Revision Optics received FDA approval of their flagship products—the KAMRA and the Raindrop—in April 2015 and June 2016. The two eye inlays bring objects into focus by letting more light reach the retina, the former through an aperture or pinhole in the inlay, the latter by way of a gel that reshapes the cornea’s anterior curvature.
Presbia takes a slightly different view.
“Think of it as a very, very small [prescription-based] contact lens [implant which] you can change when you get older and your vision further deteriorates,” Fenton said.
Phase two trials on the lens implant’s safety and effectiveness have about 350 patients enrolled. Presbia plans to file for FDA premarket approval next year, company regulatory filings said.
Commercialization, in the meantime, can continue overseas, with a focus on South Korea and Germany—producing dual marketing approaches for different markets.
Korea has largely “an aesthetics market, and our product allows you to not wear reading glasses,” Fenton said, but in Germany presbyopia surgery “is more for convenience than aesthetics.”
Vision Quest
Presbia’s 2015 IPO priced 4.2 million shares at $10 a share—below an originally stated range of $11 to $13, according to IPO research firm Renaissance Capital.
The offering last month sold 3.6 million shares at $3 a share, and the company recently traded at $3.20 and a market cap of $56 million. It had planned to offer up to 4.5 million shares.
Presbia lost $15.8 million last year and $18.2 million in 2015.
The company’s foreseeable future is connected to Irvine. It ranked No. 68 on the Business Journal list of public companies in Orange County (see page 10).
Presbia declined to say where new hires would be located, but a regulatory filing said it has stopped buying its lenses from an Israel-based supplier, and filings state the company could increase production here.
Its Irvine digs include office, labs, and manufacturing space that add up to 17,600 square feet—about 94% of 18,748 total square feet, as listed in filings.
Its local lease for its manufacturing space is up in May, and Fenton said Presbia plans to extend its stay.
It also has facilities in Dublin, Ireland, and Amsterdam, the Netherlands.
