NeoVista, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the
company’s request to expand the number of sites participating in its
pivotal Phase 3 trial from 10 to 30 in the United States. The approved
expansion of CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN
Epiretinal Therapy) trial, which seeks to evaluate the safety and efficacy
of the company’s novel epiretinal brachytherapy for the wet form of
age-related macular degeneration (AMD), was dependent on the FDA’s review
of 90-day safety data, typical of new-to-market medical devices.

“With this expansion to 30 sites, we will not only be able to recruit
more patients at a higher rate, taking us one step closer to
commercialization in the United States, but it will also allow additional
retina specialists to see the benefits of our novel therapy first-hand
while treating their patients,” said John N. Hendrick, President and CEO of
NeoVista. “It’s an exciting time at NeoVista with our recent CE Mark
approval in the EU and the FDA approval of our trial expansion. We are
getting closer and closer to seeing our investigational therapy become an
approved treatment option for millions of patients worldwide afflicted with
wet AMD.”

CABERNET 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 brachytherapy, delivered
utilizing a limited vitrectomy, concomitant with two intravitreal
injections of the FDA-approved antiangiogenic therapy Lucentis(R)
(ranibizumab) versus Lucentis alone. For those enrolled in the trial arm
utilizing brachytherapy, Lucentis is injected once at the time of the
surgery and once again 30 days later. The co-primary endpoints in the
CABERNET trial are 1) the noninferiority of epiretinal brachytherapy plus
Lucentis versus Lucentis alone based on the proportion of subjects losing
fewer than 15 letters on the Early Treatment Diabetic Retinopathy Study
(ETDRS) chart at 12 months as compared to baseline or 2) the superiority of
epiretinal brachytherapy plus Lucentis versus Lucentis alone based on the
proportion of subjects gaining 15 letters or more on the ETDRS chart at 12
months.

In contrast to previous forms of radiation therapy for wet AMD,
NeoVista’s therapy delivers a one-time peak dose of beta particle energy
(24 Gy) directly to the lesion, and the normal retinal vasculature receives
minimal exposure. 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; the
radiation exposure within the ocular compartment is below the clinical
threshold of observable tissue damage for all structures including the
lens, optic disc, and retina. 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.

Prior to the CABERNET trial, the company had conducted a feasibility
trial to test the efficacy and safety of their brachytherapy device when
used concomitantly with two intravitreal injections of Avastin(R)
(bevacizumab), which yielded promising results after 12 months. At the 1
year follow-up evaluation of 33 participants, subjects had experienced a
mean improvement in best-corrected visual acuity of 10 letters from
baseline using the ETDRS chart.

About NeoVista, Inc.

NeoVista, Inc. is a privately held development-stage medical device
company based in Fremont, California. NeoVista’s epiretinal brachytherapy
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. NeoVista recently got approval to apply the CE Mark on
its device overseas, giving them ability to distribute and sell its product
throughout all EU countries. For more information about the company, the
clinical trial or this novel wet AMD therapy, please visit the company’s
Web site at neovistainc.

NeoVista, Inc.
neovistainc

View drug information on Lucentis.