Earlier this month, federal regulators approved the first implantable eye telescope for elderly people with an advanced form of macular degeneration, which can cause a blind spot in the center of their vision, making even simple tasks a challenge.
The development is great news for the eight million people in America who suffer from macular degeneration and particularly the two million with an advanced form of the disease, according to estimates by the National Eye Institute of United States.
Still, the company behind the pea-size telescope, VisionCare Opthalmic Technologies, isn’t at the finish line yet — it now must conduct two post-approval studies — and it’s been a long race already. The company has been developing the telescope since 1997, but it ran into a major stumbling block in 2006, when an FDA advisory panel recommended the telescope not be approved because of concerns over its usefulness and safety. (Following more studies, a later panel unanimously approved the device.) In the meantime, investors, who’ve backed the company with $59 million and have followed its ups and downs with both joy and frustration, have wondered: when, when, when?
I recently spoke with one of those investors, and a VisionCare board member since 2002, Leslie Bottorff of Onset Ventures. We talked about the process, the highs and lows around VisionCare, and how the current process of getting its product’s FDA approval impacts the way she invests in other medical device companies.
From what I’ve read, this is the first device to treat age-related macular degeneration. Is that right?
Yes, there are a couple of drugs, including Lucentis, a huge, blockbuster Genentech drug that came out in 2003 or 2004, but that’s for a different form of the disease: wet age-related macular degeneration. [Editor’s note: dry AMD occurs when light-sensitive cells in the macula gradually break down, blurring vision. Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula. They’re fragile and leak blood, causing the macula to rise above its normal place in the back of the eye — and prompting loss of central vision quickly.]
The dry form is much more common. More than 85 percent of all people with intermediate and advanced AMD combined have the dry form. But of advanced AMD, about two-thirds of sufferers have the wet form.
Medical devices sometimes receive FDA approval fairly quickly; was this a longer process than you anticipated?
That would be an understatement. There’s huge controversy over the FDA making a regulatory process called the 510K — intended for products that are substantially equivalent to existing products — more rigorous. It’s right now supposedly much quicker and less expensive than the process that involved VisionCare, called the PMA process, which is longer and more stringent and grown longer and more difficult in recent years, as VisionCare’s experience would suggest.
It’s been five years since we submitted the PMA, which is way longer than PMAs are supposed to take. This is the poster child of what’s happened with the FDA and why it’s been so much harder to invest in medical devices.
What happened specifically?
In 2002, there was a pilot study — a small clinical trial. We then invested in a U.S. pivotal study, a big trial involving the many more patients that the FDA would require for final approval, after which we followed up with those patients for two years.
There were other communications and steps along the way. You usually do a panel — the FDA pulls together doctors who help them evaluate technologies. The panel that reviewed [VisionCare’s telescope] said [in 2006] that they didn’t think it was approvable at that time, that there was a question about the device. But they said: If you get information about the corneal health of patients [you can move forward].
Well, the company thought, we’ll get that data, pull it together, and maybe it will it will be another year. Instead, three years later, the [FDA] did another eight-person panel, and the panel said: This is fantastic; you should approve this right away, it’s been too long, these patients are already blind. From there, though, it took another 15 months [for the device to receive FDA approval]. It’s been quite a story.
So you think the FDA has become overly concerned about rushing through approvals?
They’re very concerned, understandably. The impetus was a couple of recalls that were well-publicized, including [the arthritis drug] Vioxx [after a study examining the drug’s impact on bowel cancer found that it caused an almost twofold increase in heart attacks and strokes].
But the medical world isn’t free of complications. Whatever people are using, there are complications involved. So [the scrutiny] is well-intention, but in their eagerness to be more stringent, which started changing about five years ago, they aren’t thinking about the people who are doing without these technologies. And it’s endangering investment in stuff that’s revolutionary.
How would you rate the current administration’s efforts?
The new administration vowed to restore credibility to the agency, not to get more devices out. Again, it’s well-intentioned, but it’s been a tremendous problem, and it’s discouraged investment.
At Onset, we still intend to invest in some technologies that are important and that we believe can be commercial successes, but we’ll do fewer and we’ll have to syndicate with a large number of firms so that we can ensure that enough money is around the table to get [those products] through the approval process.