NeoVista Epi-Retinal Strontium 90 Treatment for AMD: Update 2
Also, please see the latest updated information about the CABERNET Trial below.
NeoVista initiated this study to test the efficacy and safety of their novel beta radiation epiretinal therapy when used in combination with Avastin. In the ongoing non-randomized, multi-center feasibility study, 34 subjects with predominantly classic, minimally classic, or occult (with no classic) CNV received a single 24 Gy treatment of NeoVista's Strontium-90 epi-retinal therapy in combination with two injections of Avastin, one dose at the time of radiation delivery and another one month later.
After twelve months follow-up, as shown in the updated graph below, subjects experienced a mean improvement of visual acuity of 13.1 letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) test. Ninety-six percent of patients lost less than 15 letters of visual acuity. Only 15%, or five patients in the study, required additional injections of Avastin – four patients received one additional injection, and one patient received two injections – throughout the year, while 85% had no additional injections and, only 12% of patients experienced adverse events related to the procedure (retinal tear, retinal detachment, subretinal hemorrhage, and vitreous hemorrhage).One patient developed a retinal tear which was easily treated.
Jeffrey S. Heier, MD, a retinal specialist and partner at Ophthalmic Consultants of Boston, presented the one-year followup data attained from 27 trial participants (mean age, 72 years) from June 2006 to April 2007 in two centers in Brazil and one in Mexico. Dr. Heier is a consultant for NeoVista, Inc.
"The one-year data provides important evidence that this novel concomitant treatment approach may provide more sustainable options for those suffering from this degenerative condition," said Dr. Heier. "NeoVista's targeted beta radiation in this study demonstrated its differences from previous attempts by the medical community to use radiation for the treatment of wet AMD. Additional on-going studies may well confirm the viability of this new therapeutic option for the elderly with wet AMD."
Unlike previous forms of radiation therapy for Wet AMD, NeoVista's approach delivers the peak dose of radiation directly to the lesion without damaging the underlying choroidal vasculature. Utilizing strontium-90, the focused radiation is delivered to a target area 3 mm in depth and up to 5.4 mm in diameter. Importantly for patients, the systemic exposure to radiation is minimal, as the effective dose to the entire body from NeoVista's epi-retinal device is comparable to 15 minutes of exposure to the sun.
"The ultimate promise of this therapy revolves around that fact that NeoVista's targeted radiation delivery system allows patients to continue living their lives, with significantly less injections, while also having the potential to save both patients and the healthcare system billions of dollars," said John N. Hendrick, President and CEO of NeoVista. "We look forward to unveiling the true impact of our therapy on patients and physicians now that our larger CABERNET trial is underway."
The CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epi-retinal Therapy) trial is a multi-center, randomized, controlled study which will enroll 450 subjects at 30 sites worldwide (20 in the United States). The study, which will evaluate the safety and efficacy of NeoVista's beta radiation epi-retinal therapy delivered concomitantly with the FDA approved antiangiogenic therapy, Lucentis, versus Lucentis alone, was started in June 2007.
(For additional background information on the NeoVista Epi-Retinal treatment, see my two prior reports posted on July 11, 2007, and February 14, 2007.)
NeoVista, Inc. announced on April 17, 2008, that the U.S. Food and Drug Administration (FDA) had granted the company’s request to expand the number of sites participating in its pivotal Phase 3 trial from 10 to 30 in the United States. The approved expansion of CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial, which seeks to evaluate the safety and efficacy of the company’s novel epiretinal brachytherapy for the wet form of age-related macular degeneration (AMD), was dependent on the FDA’s review of 90-day safety data, typical of new-to-market medical devices.
“With this expansion to 30 sites, we will not only be able to recruit more patients at a higher rate, taking us one step closer to commercialization in the United States, but it will also allow additional retina specialists to see the benefits of our novel therapy first-hand while treating their patients,” said John N. Hendrick, President and CEO of NeoVista. “It’s an exciting time at NeoVista with our recent CE Mark approval in the EU and the FDA approval of our trial expansion. We are getting closer and closer to seeing our investigational therapy become an approved treatment option for millions of patients worldwide afflicted with wet AMD.”
CABERNET is a multicenter, randomized, controlled study that will enroll 450 subjects at clinical centers worldwide. The study will evaluate the safety and efficacy of NeoVista’s epiretinal brachytherapy, delivered utilizing a limited vitrectomy, concomitant with two intravitreal injections of the FDA-approved antiangiogenic therapy Lucentis® (ranibizumab) versus Lucentis alone. For those enrolled in the trial arm utilizing brachytherapy, Lucentis is injected once at the time of the surgery and once again 30 days later. The co-primary endpoints in the CABERNET trial are 1) the noninferiority of epiretinal brachytherapy plus Lucentis versus Lucentis alone based on the proportion of subjects losing fewer than 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 12 months as compared to baseline or 2) the superiority of epiretinal brachytherapy plus Lucentis versus Lucentis alone based on the proportion of subjects gaining 15 letters or more on the ETDRS chart at 12 months.