PowerVision, Inc., based in Belmont, California, south of San Francisco, is a private ophthalmic start-up company focused on developing the FluidVision accommodating IOL (Figure 1). A nonfoldable version of the FluidVision lens has been implanted in sighted eyes, and clinical trials with a foldable version are expected to begin in Europe later this year. The lens uses a novel approach to accommodation: Forces exerted on the haptics by the accommodative muscles of the eye drive fluid into and out of the lens optic, changing the shape of the optic and altering its refractive power.
CRST Europe spoke with PowerVision Cofounder, President, and Chief Executive Officer (CEO) Barry Cheskin to learn about the genesis of the company and the prospects for the FluidVision IOL.
CRST Europe: Tell us about the origins of the company.
Barry Cheskin: PowerVision got started in earnest in 2005 when we raised our first round of funding and began hiring our first employees. A number of people have been involved in the company over time, but two of us in particular got the company going, my partner Matt Frinzi and I. We’re both veterans of the medical device industry and ophthalmology.
I’m a serial start-up CEO; this is my third venture. My early training was in mechanical engineering, and I spent the beginning of my career as a mechanical engineer in the medical device industry. I later got my MBA and moved into management consulting, business development, and general management. Prior to my first role as CEO of a start-up, I was a division president at a large medical device company.
Matt Frinzi, our chief business officer, is a veteran of the medical device industry and the ophthalmology area. He has held a variety of senior management roles, including running a US-based IOL sales force for Johnson & Johnson. That was where Matt started his career in the medical device industry.
CRST Europe: The concept of the fluid-driven accommodating IOL is different from any other approach to restoring accommodation. Where did the idea come from?
Cheskin: The initial patents for the process were originally in-licensed by Matt from some inventors outside the ophthalmology space, interestingly. But the actual product and the vast majority of our intellectual property have been developed since the company was funded. We started with those few ideas that had been licensed in, but we really brought them to life. There was an idea on a piece of paper and a few mathematical analyses, but there was no hardware.
The fundamental design is substantially the same that we started with in our first prototypes. We have streamlined and simplified along the way, but we’ve stuck with the basic idea, and it has been working great.
CRST Europe: Can you briefly describe how the mechanism of action works?
Cheskin: To give the napkin-sketch version, we use the natural muscle-accommodating forces of the eye to transport fluids in the lens. That results in shape change of the lens, similar to what occurs in the crystalline lens, from thin to thick or from flat to more curved. We can create an accommodative range of more than 5.00 D on average, which is about the natural accommodative range of a healthy 35-year-old human eye. The only commercially available competitive technology cannot create more than 1.00 D of accommodative range, and arguably that. Our real advantage, the unique element of the design, is the fluid and the shape change.
The two haptics in our lens design are not like typical IOL haptics; they could be described more like pontoons. Those haptic pontoons and the lens optic are tucked into the capsule after cataract removal (Figure 2). As the capsule acts on those pontoons, they pump fluid into the lens optic, which inflates the optic and increases its curvature. As the capsule relaxes, the haptics withdraw the fluid and flatten the lens. In essence, the haptics are pumping fluid into and out of the center of the lens, changing the shape and refractive power of the optic.
The FluidVision IOL has been called a fluid-filled lens, but the lens contains only about 30 μL of fluid (less than 1 drop). This amount is enough to drive the shape change and power change.
CRST Europe: What is the status of clinical trials?
Cheskin: A nonfoldable version of the lens has been implanted in sighted eyes. One-year follow-up of those patients showed that the base IOL powers were accurate and stable, visual acuities were good, and patients showed more than 5.00 D of accommodation on average.1 That was our original design, but we always intended to implement, and are now implementing, a foldable design. We plan to go into trials with that foldable version later this year in Europe and South Africa, where we have some terrific investigators lined up.
Designing the insertion system took creativity and innovation, but we’ve come up with a novel way of inserting this device through a standard small incision. The lens may look bulky, like an inner tube or a balloon, but, as I said, it has less than 1 drop of fluid in it. Nevertheless, the FluidVision does require a novel insertion method. Keeping with the liquid theme of our fluid-driven lens, we have developed a proprietary inserter design that uses fluids to load the lens into the delivery system and deliver it gently into the eye.
We are shooting, initially, for the lens to go through an incision of 4 mm or less. Over time, we think we can make the incision smaller, but sub–4-mm will be our starting point.
CRST Europe: Some people would call that a large incision at this point.
Cheskin: It’s all relative, isn’t it? At this time, if we can deliver true restoration of accommodative ability, which we believe no one else can do, we think the market will be responsive to a device that goes through a sub–4-mm incision, and over time we believe we can make that smaller. The amount of accommodation we can deliver is a step change from existing technologies, and we think that’s a good spot for us to be in.
CRST Europe: Is manufacturing a fluid-filled lens more difficult that a standard plastic IOL?
Cheskin: It is different, although some aspects are similar. We have a number of veterans of the ophthalmic industry on our team who have used a lot of tricks of the trade, and we’ve had to invent a few of our own as well. It took some innovation to think about how to design this lens, and it took innovation to think about how to make it, too. Having now figured out how to make it, it’s not especially difficult.
CRST Europe: Have you attracted sufficient financial backing to do what you want to do with the lens?
Cheskin: I think we have. We have a great line-up ofhigh-quality venture investors. We’ve also brought in terrific corporate investors, including Johnson & Johnson and Medtronic, and we recently completed our Series C venture capital financing, which totaled more than $37 million, in addition to the $29 million we brought in previously. This funding will be used to support our continued research and development efforts and our planned clinical trials. We’ve had great financial interest in the concept, and we’re in a strong financial position. There’s a natural interest in the idea of restoring accommodation, and I think we’re seen by many as having a leading concept in this space.
CRST Europe: What do you foresee for the future of the company and the lens?
CheskinM: We feel great about our future. We’re looking forward to beginning our trials in Europe and trying to bring this technology into the marketplace there.
In classic fashion in this industry, we’ll be doing our first clinical trials outside the United States, and we will use the results of those to secure marketing approval in Europe and also to secure approval to begin trials in the United States. We plan to begin US trials after the European trials have delivered their early endpoints. We intend to do a fullscale clinical trial in the United States leading to regulatory approval and to introduce the lens there as well.
Barry Cheskin is Cofounder, President, and CEO of PowerVision, Inc. He may be reached at tel: +1 650 620 9948 x212; e-mail bcheskin@ powervisionlens.com.
- Nichamin LS. Initial study of the feasibility of injecting a fluid-filled Aiol through a small incision. Paper presented at: ASCRS Symposium and Congress; March 25-29, 2011; San Diego.