MAUI, Hawaii, Oct. 13 /PRNewswire/ -- NeoVista, Inc., presented yesterday the anatomic effects of the company's novel epiretinal brachytherapy device on choroidal neovascular lesions in an analysis at the American Society of Retina Specialist's (ASRS) 26th Annual Meeting. The 12-month data presented by David Brown, MD, F.A.C.S., of The Methodist Hospital, Houston, Texas, demonstrated anatomic improvements on both angiography and ocular coherence tomography (OCT) in many patients treated in the ongoing pilot study. NeoVista's therapy, when delivered concomitantly with an intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent, demonstrated a marked reduction in choroidal neovascular membrane (CNVM) size in many patients in the trial, which has not been seen in previous anti-VEGF monotherapy trials.
The current standard of care for wet AMD involves repeated monthly intravitreal injections of an anti-VEGF agent for an indefinite period of time. In contrast, NeoVista's therapy applies a targeted dose of beta radiation to the leaking blood vessels that affect central vision; concomitantly, two injections of an anti-VEGF agent are delivered one month apart to maximize the acute therapeutic response and additional anti-VEGF injections are given on a PRN basis.
"After reviewing the anatomical data outcomes from the Phase II pilot study, I believe this concomitant approach to treating wet AMD looks promising as a potential way to decrease the number of required injections necessary in the treatment of patients with neovascular AMD," said Dr. Brown. "At 12 months, many patients were fluid free on OCT with reductions in FFA lesion size despite being undertreated with the PRN anti-VEGF agents. As this biologic response seems to be observed at six to nine months after the epiretinal brachytherapy procedure, my personal opinion is that the use of more anti-VEGF therapy immediately post treatment may improve the excellent visual acuity results which have previously been presented from this trial. This hypothesis will be tested in the ongoing multicenter Phase III registration trial."
Dr. Brown's analysis examined over 1400 images from patients enrolled in the company's ongoing Phase II pilot study, which includes 34 trial participants (with a mean age of 72 years) treated from June 2006 to April 2007 at two centers in Brazil and one in Mexico. These patients, 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 intravitreal injections of an anti-VEGF agent (bevacizumab), which are delivered to maximize the acute therapeutic response. Preliminary data show that NeoVista's targeted radiation therapy is well tolerated and may provide a new approach to restore the patient's vision and improve their quality of life.
"Dr. Brown's analysis is providing valuable information on our novel technology," said John N. Hendrick, President and CEO of NeoVista. "For someone with his credibility and expertise in the field of retinal medicine to independently analyze and present this data is quite encouraging and provides further proof of concept of our technique. We know that the mechanism of action of radiation is different from any therapy currently available for wet AMD and we look forward to the potential promise of significantly decreasing the burden of wet AMD therapy."
The observational analysis was presented at ASRS while NeoVista continues to enroll patients in the company's pivotal Phase III trial, CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy). CABERNET is a multicenter, randomized, controlled study that will enroll 450 subjects at 45 sites worldwide, evaluating the safety and efficacy of NeoVista's epiretinal brachytherapy delivered concomitantly with the FDA-approved anti-VEGF 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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