Advertisement
The current standard of care for wet AMD involves repeated monthlyintravitreal injections of an anti-VEGF agent for an indefinite period oftime. In contrast, NeoVista's therapy applies a targeted dose of betaradiation to the leaking blood vessels that affect central vision;concomitantly, two injections of an anti-VEGF agent are delivered one monthapart to maximize the acute therapeutic response and additional anti-VEGFinjections are given on a PRN basis.
Advertisement
"After reviewing the anatomical data outcomes from the Phase II pilotstudy, I believe this concomitant approach to treating wet AMD looks promisingas a potential way to decrease the number of required injections necessary inthe treatment of patients with neovascular AMD," said Dr. Brown. "At 12months, many patients were fluid free on OCT with reductions in FFA lesionsize despite being undertreated with the PRN anti-VEGF agents. As thisbiologic response seems to be observed at six to nine months after theepiretinal brachytherapy procedure, my personal opinion is that the use ofmore anti-VEGF therapy immediately post treatment may improve the excellentvisual acuity results which have previously been presented from this trial.This hypothesis will be tested in the ongoing multicenter Phase IIIregistration trial."
Dr. Brown's analysis examined over 1400 images from patients enrolled inthe company's ongoing Phase II pilot study, which includes 34 trialparticipants (with a mean age of 72 years) treated from June 2006 to April2007 at two centers in Brazil and one in Mexico. These patients, withpredominantly classic, minimally classic, or occult (with no classic)choroidal neovascularization (CNV), received a single 24 Gy treatment ofNeoVista's epiretinal brachytherapy in combination with two intravitrealinjections of an anti-VEGF agent (bevacizumab), which are delivered tomaximize the acute therapeutic response. Preliminary data show that NeoVista'stargeted radiation therapy is well tolerated and may provide a new approach torestore the patient's vision and improve their quality of life.
"Dr. Brown's analysis is providing valuable information on our noveltechnology," said John N. Hendrick, President and CEO of NeoVista. "Forsomeone with his credibility and expertise in the field of retinal medicine toindependently analyze and present this data is quite encouraging and providesfurther proof of concept of our technique. We know that the mechanism ofaction of radiation is different from any therapy currently available for wetAMD and we look forward to the potential promise of significantly decreasingthe burden of wet AMD therapy."
The observational analysis was presented at ASRS while NeoVista continuesto enroll patients in the company's pivotal Phase III trial, CABERNET (CNVSecondary to AMD Treated with BEta RadiatioN Epiretinal Therapy). CABERNET isa multicenter, randomized, controlled study that will enroll 450 subjects at45 sites worldwide, evaluating the safety and efficacy of NeoVista'sepiretinal brachytherapy delivered concomitantly with the FDA-approvedanti-VEGF therapy Lucentis(R) (ranibizumab) versus Lucentis alone.
About NeoVista, Inc.
NeoVista, Inc. is a privately held development-stage medical devicecompany based in Fremont, California. NeoVista's epiretinal beta radiationtherapy is currently being studied in a definitive Phase III clinical study tosupport eventual filing for regulatory approval to market the product in theUnited States. For more information about the company, the clinical trial orthis novel wet AMD therapy, please visit the company's Web site atwww.neovistainc.com .
SOURCE NeoVista, Inc.