Data Analysis Shows Promise of Epiretinal Brachytherapy as NeoVista
Progresses with Phase III CABERNET Study
PALM BEACH, Fla., March 28 /PRNewswire/ -- NeoVista, Inc. released today to the eye community updated results from a one-year feasibility study of the company's novel epiretinal brachytherapy for the wet form of age-related macular degeneration (AMD) at the 31st Annual Macula Society Meeting in Palm Beach, Florida. The promising data from the study, which was initiated by NeoVista to test the efficacy and safety of their novel therapy when used in conjunction with Avastin(R) (bevacizumab), showed a marked improvement in mean visual acuity.
In the ongoing nonrandomized, multicenter feasibility study, 34 subjects with predominantly classic, minimally classic, or occult (with no classic) choroidal neovascularization (CNV) received a single 24 Gy treatment of NeoVista's epiretinal brachytherapy in combination with two injections of Avastin, one dose prior to or at the time of radiation delivery and another one month later, depending on which arm of the trial the patient was enrolled in.
After 12 months of follow-up on 33 of the trial participants, subjects had experienced a mean improvement in visual acuity of 10 letters using the Early Treatment Diabetic Retinopathy Study (ETDRS) test; 94 percent of patients lost fewer than 15 letters, 39 percent gained 15 or more letters, and 12 percent gained 30 or more letters. 76 percent of the patients in the study did not require additional injections of Avastin throughout the year.
Most adverse events were related to the vitrectomy procedure (retinal tear, retinal detachment, subretinal hemorrhage, and vitreous hemorrhage). No events related to radiation toxicity have been reported to date.
Jeffrey S. Heier, MD, a retinal specialist, partner at Ophthalmic Consultants of Boston and a consultant for NeoVista, presented the one-year data obtained from trial participants (mean age, 72 years) who enrolled from June 2006 to April 2007 at two centers in Brazil and one in Mexico.
"As more data are collected and analyzed surrounding this one-time surgical procedure, we're continuing to see the potential of the concomitant approach to treat wet AMD," said Dr. Heier. "Unlike previous attempts with radiation therapy, NeoVista has developed a means of delivering targeted beta radiation to choroidal neovascular membranes with minimal penetration, resulting in little effect on the surrounding healthy tissue."
In contrast to other forms of radiation therapy for wet AMD, NeoVista's approach delivers the peak dose of energy directly to the lesion without irreparably damaging the normal retinal vasculature. Utilizing strontium 90, the focused energy is delivered to a target area up to 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 less than that from a typical chest x-ray.
"We've seen a significant amount of promise so far with epiretinal brachytherapy and we're excited to see the ultimate potential of the therapy when evaluated in our definitive Phase III trial," said John N. Hendrick, President and CEO of NeoVista. "Patients will finally be able to have access to a treatment for wet AMD that not only has the possibility of restoring their vision, but also saving them money and alleviating the difficulties of current treatment regimens for all involved -- patients, caretakers and physicians."
The CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial 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 beta radiation therapy delivered concomitantly with the FDA-approved antiangiogenic therapy Lucentis(R) (ranibizumab) versus Lucentis alone.
About NeoVista, Inc.
NeoVista, Inc. is a privately held development-stage medical device company based in Fremont, California. NeoVista's epiretinal beta radiation therapy is currently being studied in a definitive Phase III 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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