The potential of this treatment is enormous
San Francisco, CA (PRWEB) October 27, 2009
NeoVista, Inc. made public at the American Academy of Ophthalmology meeting the company's interim study results from the preliminary study MERITAGE-I. The study was designed to examine the company's novel epimacular brachytherapy procedure when used in patients that require chronic therapy with anti-VEGF agents on an ongoing basis to control their neovascular AMD. The study enrolled patients that had as many as 23 injections of anti-VEGF therapy before receiving epimacular brachytherapy. All patients that entered the study were required to have received a minimum of 8 injections in the past 12 months or 6 injections in the past 6 months preceding enrollment. Preliminary study results (n=16) suggest that a single procedure of epimacular brachytherapy can further improve visual acuity in a majority of this patient population while decreasing the number of injections required based on Optical Coherence Tomography imaging after the brachytherapy procedure. Most importantly, 63% of patients enrolled in the study experienced improvement in their visual acuity while 50% of patients gained 5 or more letters of visual acuity at 6 months.
"MERITAGE-I is the first of its kind study designed to evaluate the potential role of our device in decreasing the current burden of treatment while maintaining or improving visual acuity," said John N. Hendrick, President and CEO of NeoVista. "Data from recent randomized trials suggest that most patients suffering from neovascular AMD will require treatment on an ongoing basis for an indefinite period of time. We are very excited that our device has the potential to significantly decrease the number of injections administered in this patient population and may also improve visual acuity in a majority of cases."
In contrast to other forms of radiation therapy for wet AMD, NeoVista's approach delivers a focused dose of energy directly to the choroidal neovascular lesion without damaging the adjacent healthy retinal vasculature. Utilizing strontium 90, the targeted energy is delivered to a an area up to 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 epimacular device is less than that from a typical chest x-ray.
The ongoing multicenter MERITAGE study enrolled 50 trial participants (with a mean age of 79 years) at two centers in the US, one in UK, and two in Israel. These patients, with predominantly classic, minimally classic, or occult (with no classic) choroidal neovascularization (CNV), received a single exposure of epimacular brachytherapy after having received a minimum of 8 injections of anti-VEGF therapy in the past 12 months or 6 injections of anti-VEGF therapy in the past 6 months preceding enrollment. Additional anti-VEGF therapy was delivered based upon strict re-treatment criteria and the investigator's evaluation of disease activity.
There were a limited number of adverse events in the trial which were related to the vitrectomy procedure (subconjunctival hemorrhage, vitreous hemorrhage, and cataract formation), rather than the epimacular brachytherapy. To date, no instances of radiation toxicity have been reported.
The data were presented by Pravin U. Dugel, MD, managing partner, Retina Consultants of Arizona, Phoenix, AZ. "The potential of this treatment is enormous," said Dr. Dugel. "I believe that epimacular brachytherapy, unlike anti-VEGF therapy alone offers a broad spectrum of activity and may therefore inhibit the multiple disease processes involved in the pathology of neovascular AMD."
NeoVista recently completed enrollment in the company's first pivotal trial, CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy). CABERNET is a multicenter, randomized, controlled study that has enrolled over 450 subjects at 45 sites worldwide, and is evaluating the safety and efficacy of NeoVista's therapy delivered concomitantly with the FDA-approved anti-VEGF therapy Lucentis® (ranibizumab) versus Lucentis alone.
About NeoVista, Inc.
NeoVista, Inc. is a privately held medical device company based in Fremont, California. The company's first commercial product, the VIDION® ANV® Therapy System, is cleared for commercial sale in all markets that accept a CE Mark. Initial orders for the product have been received.
NeoVista, Inc is planning to begin commercial activity in the US in early 2011 pending Food and Drug Administration (FDA) approval. For more information about the company, or this novel neovascular AMD therapy, please visit the company's Web site at http://www.neovistainc.com.