| IN BRIEF • Two pioneers of competing retinal prosthetic implant systems died weeks apart in February. John Wyatt, PhD, 69, co-founder of the Boston Retinal Implant Project with Joseph Rizzo, died February 3. Alfred E. Mann, 90, founder of Second Sight Medical Products, developer of the Argus II Retinal Prosthesis, died February 24. • The ForeseeHome AMD Monitoring Program has qualified for Medicare coverage, Notal Vision announced. ForeseeHome is a home-monitoring program available by prescription for patients with dry age-related macular degeneration at high risk for developing wet AMD. • Retinal prosthesis investigator Mark S. Humayun, MD, PhD, has been named recipient of the National Medal of Technology and Innovation from President Barack Obama. Dr. Humayun developed the retinal prosthesis that eventually became the Argus II. He is a professor of ophthalmology, biomedical engineering and cell and neurobiology at the Keck School of Medicine, University of Southern California. • Biotech firm Amarantus BioScience has requested Rare Pediatric Disease Designation from the Food and Drug Administration for its mesencephalic-astrocyte-derived neurotrophic factor (MANF) for treating retinitis pigmentosa. MANF was previously granted orphan drug designation by the FDA in December 2014. |
James Tahara Handa, MD, Robert Bond Welch Professor at Johns Hopkins Wilmer Eye Institute, reported on the five-year results of the Argus II (Second Sight Medical Products) last month at the 39th annual Macula Society meeting on behalf of the Argus II Study Group. The five-year study involved 30 subjects from the clinical trial who received the implants at 10 centers. All were blind, defined as bare light perception or worse, due to retinitis pigmentosa or other disorders before the implant.
“The five-year data looks basically the same as the three-year data in the two primary components: the adverse events rate did not change; and the performance of when people used the Argus II turned on was maintained,” Dr. Handa said. Serious adverse events totaled 24, all of which were “addressed with standard ophthalmic techniques,” and no eyes were lost, Dr. Handa says. Most complications related to the Argus II occurred in the first year after implantation.
But results of those who have had the implant since the device was first approved for commercial use in Europe in 2011 are even more encouraging, Dr. Handa tells Retina Specialist.
“There were 111 patients who had the implant placed worldwide after it was approved, and the adverse event rate was actually lower for each category of possible complication since the commercial rollout than during the first year of the trial,” he says.
While the reason for the improvement in outcomes hasn’t been studied, Dr. Handa says it may be attributable to three factors: surgeons are getting better with experience; Second Sight’s center-of-excellence strategy that requires implant sites meet specific requirements before the company approves them to implant the device; and innovations in surgical techniques to avoid adverse events, along with the company’s program to sit in during operations to address potential problems.
In the five-year study, the following percentages of patients reported improvement in these visual function tests with the Argus II turned on compared to baseline:
• Square Localization (ability to locate and touch a high-contrast target), 81 percent.
• Direction of Motion (ability to determine the direction of a high-contrast target), 50 percent.
• Grating Visual Acuity, (ability to distinguish the orientation of black and white bars of different widths), 38 percent.
As a group, performance on the Door and Line Orientation and Mobility tasks was significantly better, Dr. Handa said.
Can High-Dose Lipitor Cause Drusen Regression in AMD?
Treatment with high-dose atorvastatin has been found to cause regression of lipid deposits and improve visual acuity without progression to advanced disease in patients with dry age-related macular degeneration.
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| “These data suggest that it may be possible to eventually have a treatment that not only arrests the disease but also reverses its damage and improves the visual acuity in some patients.” - Demetrios Vavvas, MD, PhD |
Twenty-three subjects completed the minimum 12-month follow-up. High-dose atorvastatin resulted in regression of drusen deposits associated with vision gain (+3.3 letters, p = 0.06) in 10 patients. Thirteen patients were considered non-responders. No subjects progressed to advanced neovascular AMD.
“Not all cases of dry AMD are exactly the same, and our findings suggest that if statins are going to help, they will be most effective when prescribed at high dosages in patients with an accumulation of soft lipid material,” says Demetrios Vavvas, MD, PhD, a clinician scientist at Massachusetts Eye and Ear and co-director of the Ocular Regenerative Medicine Institute at Harvard Medical School.
“These data suggest that it may be possible to eventually have a treatment that not only arrests the disease but also reverses its damage and improves the visual acuity in some patients,” he says.
The study further validates an association between lipids, atherosclerosis and retinal disease. A 2010 study involved 18 subjects with diabetic macular edema and dyslipidemia who received an unspecified dose of atorvastatin.2 They showed a decrease in hard exudates and fluorescein leakage at 12 months. RS
REFERENCES
1. Vavvas DG, Daniels AB, Kapsala ZG, et al. Regression of some high-risk features of age-related macular degeneration (AMD) in patients receiving intensive statin treatment. EBioMedicine. In Press.
2. Panagiotoglou TD, Ganotakis ES, Kymionis GD, et al. Atorvastatin for diabetic macular edema in patients with diabetes mellitus and elevated serum cholesterol. Ophthalmic Surg Lasers Imaging. 2010;41:316-322.
