Medical Device Daily Washington Editor

Those suffering from macular degeneration face a gradual loss of vision in the central visual field. As the macula degrades, what starts out as vaguely fuzzy vision ends with a hole in the center of the visual field, rendering ordinary daily tasks, such as reading, difficult at best. Social interaction is also affected inasmuch as eye-to-eye contact is greatly reduced.

VisionCare (Saratoga, California) has tackled the particularly difficult feat of amending the loss of central visual field, albeit not by means of treating the macula directly.

Thanks to technology developed by Israeli scientists Isaac Lipshitz, MD, and Yossi Gross at the company's research facilities in Yehud, Israel, help may be on the way. But the company will have to take another crack at the FDA approval process before sufferers in the U.S. can benefit.

The Phase II/III clinical trial, which commenced in early 2003, recently closed and the firm presented its findings to an FDA advisory panel July 14. However, VisionCare's clinical data were not enough to nail down positive votes by the panel. Panelists voted to recommend against final FDA approval.

VisionCare's implantable miniature telescope, or IMT (Medical Device Daily, Jan. 15, 2003), is designed for adults with bilateral, stable, but untreatable impairment of central vision of moderate to profound severity. This impairment can be due to macular degeneration or any other disorder of similar characteristics.

The IMT is a prosthetic telephoto lens 4 mm in length that enlarges images by a factor of either 2.2 or 2.7, depending on the model chosen. VisionCare says that the double-lens device will not completely fill in the blind spot characteristic of macular degeneration, but will trim down the blind spot by refracting incoming light to still-functioning parts of the retina outside the macula. Because the device reduces peripheral vision, it is installed in only one eye. The IMT corrects visual field for intermediate and distant images, leaving the user in need of external correction for near-field vision in that eye.

The IMT has the shape of a stubby cylinder with two curved arms extending to the side from roughly halfway up the circumference. Known as haptic loops, these pressure-sensitive extensions keep the device fixed in place. The central portion of the device contains stainless steel, which may disallow the use of magnetic resonance technology unless compatibility is established.

VisionCare conducted a prospective, multicenter trial (28 sites) with 218 subjects with a primary efficacy endpoint of “an improvement of two lines or greater” in either near or distant best-corrected acuity in at least half the implanted eyes after 12 months. The device did well on this measure, ringing in at 90.1% of implanted eyes with an improvement of at least two lines.

The primary safety endpoint, which is where the company's application fell short, was the average loss of endothelial cell density less than or equal to 17% at the one-year mark. Unfortunately, mean endothelial cell density fell 25.3% (both the cornea and the retina possess endothelial cells, but it is perhaps safe to assume that the reference is to corneal endothelia).

Despite that shortfall, VisionCare won three votes from the panel of 13. FDA panels sometimes demonstrate leniency on such measures for devices that address a critical need that is otherwise unmet, but such considerations did not carry the day for the IMT.

At least one member of the panel had a problem with a lack of morphometric analysis of the endothelial cell density data, which would have allowed calculation of the chronic rate of endothelial cell density loss. The panel also found efficacy data somewhat less than fully persuasive because of what were seen as confounders may have given a greater impression of visual improvement than the device actually provided.

According to VisionCare's web site, it is a “privately-held development-stage company” engaged in R&D for proprietary implantable ophthalmic devices, but the site lists no other products.

A venture capital- (VC) funded company, VisionCare's investors include California-based VC firms Onset Ventures (Menlo Park) and Three Arch Partners (Portola Valley).

In January 2005, VisionCare announced that it had nailed down a “Series D financing totaling $20 million,” obtained in part from cardiac care colossus Boston Scientific (Natick, Massachusetts).

VisionCare did not respond to calls from MDD for comment on the panel decision.

CMS issues revised NCD guidance

The Centers for Medicare & Medicaid Services (CMS; Baltimore) has released revised guidance for national coverage determinations (NCDs) that include, as a condition of payment, the development and capture of additional patient data to supplement standard claims data and help ensure that patients receive appropriate care.

“Our goal is to speed access to valuable new technologies and to promote the effective use of those technologies by providing patients and doctors with better medical evidence,” said CMS Administrator Mark McClellan, MD, PhD. He said that the guidance links “faster and more effective coverage” with “more informed clinical decision-making,” – adding the boilerplate promises of more appropriate treatment, better outcomes and “fewer unnecessary medical costs and complications.”

The release follows CMS's announcement that it is reconsidering its NCD on how it covers clinical research, to better clarify how and when CMS can pay for both routine costs and investigational costs incurred in clinical trials.

In a statement, CMS said that “Collecting additional patient data as part of the coverage process, Coverage with Evidence Development [CED], generates data on the utilization and impact of the item or service evaluated in the NCD,” so that Medicare can document the appropriateness of use under current coverage; consider future changes in coverage; and generate clinical information.

CMS said: “The specific data developed through the CED process may help ensure that the care provided to a particular beneficiary is 'reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,' the standard set by law for Medicare coverage.”

By reconsidering its NCD on coverage of clinical trials to better clarify its relationship to CED, CMS said it is providing the public “an opportunity to engage in a discussion of those changes.”

CMS posted a draft document on April 7, 2005, which drew a large number of public comments. Based on this feedback, it said, the revised guidance document introduces two precepts of CED-coverage with appropriateness determination and coverage with study participation.

New Orleans healthcare goes 'patient-friendly'

U.S. Secretary of Health and Human Services Michael Leavitt said on Monday that the federal government will help Louisiana finance a more patient-friendly healthcare system in the New Orleans area, but the new version cannot be a remake of the one that was “fraught with inefficiency” before Hurricane Katrina. Leavitt said that the destruction of hospitals and the rebuilding of medical infrastructure in the area have given the region an opportunity to design a more efficient and flexible system that focuses more on patients and less on institutions.

His remarks came during the final day of the meeting of the Southern Governors Association in New Orleans. Leavitt said he has the authority to approve changes in existing healthcare spending for the new plan, such as using federal Medicaid dollars to help pay private insurance premiums for the uninsured or poor.

He said he will sign off on a more flexible use of the federal revenue as long as the plan “is based on principles we all agree on. I will not sign one that doesn't.”

He cautioned that the new plan “should not look exactly like the current two-tiered system” in which the poor are treated at charity hospitals and clinics run by the state and paying or insured patients receive care at private hospitals and clinics.

“The old system may have served well in the old day, but that day has passed,” he said. “There is an excess of [hospital] beds in the private sector and a shortfall of beds in the public sector.” Indigent patients are using emergency rooms of state hospitals for routine care that isn't an emergency because they cannot afford private-care doctors, he said.