One-Year Data Provides Ophthalmologists Critical Insight on Novel Beta
Radiation Epiretinal Therapy
NEW ORLEANS, Nov. 12 /PRNewswire/ -- NeoVista, Inc. revealed today new data from a one-year feasibility study of the company's novel beta radiation epiretinal therapy for the wet form of age-related macular degeneration (AMD) at the 2007 Annual Meeting of the American Academy of Ophthalmology in New Orleans, Louisiana.
NeoVista initiated this study to test the efficacy and safety of their novel beta radiation epiretinal therapy when used in combination with Avastin(R). In the ongoing nonrandomized, 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 epiretinal 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, subjects experienced a mean improvement of visual acuity of 13.1 letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) test. 96% of patients lost less than 15 letters of visual acuity. Only 15% of patients in the study required additional injections of Avastin throughout the year and only 12% of patients experienced adverse events related to the procedure (retinal tear, retinal detachment, subretinal hemorrhage, and vitreous hemorrhage).
Jeffrey S. Heier, MD, a retinal specialist and partner at Ophthalmic Consultants of Boston, presented the one-year 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 epiretinal 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 Epiretinal 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 will evaluate the safety and efficacy of NeoVista's beta radiation epiretinal therapy delivered concomitantly with the FDA approved antiangiogenic therapy, Lucentis(R), versus Lucentis(R) alone.
About NeoVista, Inc.
NeoVista, Inc. is a privately held development-stage medical device company based in Fremont, California. NeoVista's beta radiation epiretinal therapy is currently being studied in a definitive clinical study to support eventual filing for regulatory approval to market the product in the United States. For more information about the company, the clinical trial or this novel wet AMD therapy, please visit the company's Web site at http://www.neovistainc.com.
|SOURCE NeoVista, Inc.|
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