Published:
NeoVista Presents Anatomic Outcomes of Novel Wet AMD Therapy at 2008 American Society of Retina Specialists Meeting
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 inBrazil and one inMexico. 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 inFremont, 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 inthe
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
www.neovistainc.com .
SOURCE NeoVista, Inc.
Copyright © 2009, PRNewswire
Copyright © 2009, NewsBlaze,
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