NeoVista, Inc. revealed new
data from a one-year feasibility study of the company's novel beta
radiation epiretinal therapy for the wet form of age related macular
degeneration (AMD) at the 2007 Annual Meeting of the American Academy of
Ophthalmology in New Orleans, Louisiana.
NeoVista initiated this study to test the efficacy and safety of their
novel beta radiation epiretinal therapy when used in combination with
Avastin(R). In the ongoing nonrandomized, multi-center feasibility study,
34 subjects with predominantly classic, minimally classic, or occult (with
no classic) CNV received a single 24 Gy treatment of NeoVista's epiretinal
therapy in combination with two injections of Avastin, one dose at the time
of radiation delivery and another one month later.
After twelve months follow-up, subjects experienced a mean improvement
of visual acuity of 13.1 letters using the Early Treatment Diabetic
Retinopathy Study (ETDRS) test. 96% of patients lost less than 15 letters
of visual acuity. Only 15% of patients in the study required additional
injections of Avastin throughout the year and only 12% of patients
experienced adverse events related to the procedure (retinal tear, retinal
detachment, subretinal hemorrhage, and vitreous hemorrhage).
Jeffrey S. Heier, MD, a retinal specialist and partner at Ophthalmic
Consultants of Boston, presented the one-year data attained from 27 trial
participants (mean age, 72 years) from June 2006 to April 2007 in two
centers in Brazil and one in Mexico. Dr. Heier is a consultant for
NeoVista, Inc.
"The one-year data provides important evidence that this novel
concomitant treatment approach may provide more sustainable options for
those suffering from this degenerative condition," said Dr. Heier.
"NeoVista's targeted beta radiation in this study demonstrated its
differences from previous attempts by the medical community to use
radiation for the treatment of wet AMD. Additional on-going studies may
well confirm the viability of this new therapeutic option for the elderly
with wet AMD."
Unlike previous forms of radiation therapy for Wet AMD, NeoVista's
approach delivers the peak dose of radiation directly to the lesion without
damaging the underlying choroidal vasculature. Utilizing strontium-90, the
focused radiation is delivered to a target area 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 comparable to 15 minutes of exposure to the
sun.
"The ultimate promise of this therapy revolves around that fact that
NeoVista's targeted radiation delivery system allows patients to continue
living their lives, with significantly less injections, while also having
the potential to save both patients and the healthcare system billions of
dollars," said John N. Hendrick, President and CEO of NeoVista. "We look
forward to unveiling the true impact of our therapy on patients and
physicians now that our larger CABERNET trial is underway."
The CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN
Epiretinal Therapy) trial is a multi-center, randomized, controlled study
which will enroll 450 subjects at 30 sites worldwide (20 in the United
States). The study will evaluate the safety and efficacy of NeoVista's beta
radiation epiretinal therapy delivered concomitantly with the FDA approved
antiangiogenic therapy, Lucentis(R), versus Lucentis(R) alone.
About NeoVista, Inc.
NeoVista, Inc. is a privately held development-stage medical device
company based in Fremont, California. NeoVista's beta radiation epiretinal
therapy is currently being studied in a definitive 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
neovistainc.
NeoVista, Inc.
neovistainc
View drug information on Avastin.