Navigation Links
FDA Grants NeoVista's Request to Expand CABERNET Trial to 30 Sites in the U.S.
Date:4/17/2008

Agency Approves Expansion of Company's Phase 3 Study for Wet AMD after

90-day Review of Safety Data

FREMONT, Calif., April 17 /PRNewswire/ -- NeoVista, Inc. announced today 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 http://www.neovistainc.com.

Contact: Tony Moses

O: 510.933.7600

C: 510.402.3394

tmoses@neovistainc.com


'/>"/>
SOURCE NeoVista, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. US FDA Grants Orphan Drug Status to Immtechs Pafuramidine for Treatment of African Sleeping Sickness
2. Chinese SFDA Grants Immtech Fast Track Status
3. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
4. NTMir Announces Research Grants for Epidemiology and Household Water as Source of Infection
5. FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
6. FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel
7. FDA Grants Priority Review for ACIPHEX(R) (rabeprazole sodium) sNDA for Short-Term Treatment of GERD in Adolescents
8. FDA Grants Priority Review for PROMACTA(R) (eltrombopag)
9. Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
10. U.S. Patent Office Rejects Key HIV/AIDS Drug Patents at PUBPAT Request: Government Finds Prior Art Submitted By PUBPAT Invalidates All of Gilead Sciences Claims
11. Portrait(R) Plasma - A New Non-Surgical Option for one of the Most Requested Aesthetic Treatment - Aging Eyes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... , May 24, 2016 Cirujanos ... para ayudar a los médicos a compartir sus mejores ... a escala mundial. Profesionales médicos de Europa, África, ... han apuntado a la aplicación, que combina la transmisión ... entorno totalmente seguro. Educación   "Imagine ...
(Date:5/24/2016)... , May 24, 2016  NxStage Medical, Inc. ... company focused on advancing renal care, today announced that ... to participate in the following schedule of investor conferences. ... made available at http://ir.nxstage.com/ .   ... Jefferies Healthcare Conference NY, NY           Friday, June 10, ...
(Date:5/24/2016)... 2016 Les ... la première endoprothèse à double thérapie au ... portant sur les membres inférieurs et la ... entreprise mondiale spécialisée dans la fourniture de ... a élargi son portefeuille pour inclure des ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... Beleza Medspa ... fat composition regulations. This is the first time that Coolsculpting is being used ... least every six months to ensure they meet the prescribed body-fat standard, measured by ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... Despite last ... meeting, expect Janet Yellen and company to wait until March 2017 for an interest ... University’s J. Mack Robinson College of Business. , “The Federal Open Market Committee (FOMC) ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... property (IP) to its specialty academic programs. , Answering to the increasing demand ... certificate programs in health law, and environmental and land use law. ,  , ...
(Date:5/26/2016)... , ... May 26, 2016 , ... There are nearly ... than 32 million cancer survivors worldwide. On Sunday, June 5, 2016, communities around the ... National Cancer Survivors Day®. , National Cancer Survivors Day® is an annual worldwide ...
(Date:5/26/2016)... , ... May 26, 2016 , ... In an effort to provide hair restoration information ... both Snapchat users and those who do not use the app. Dr. Mohebi, the founder ... page, Dr. Mohebi Live . , Dr. Mohebi says, “The positive response to ...
Breaking Medicine News(10 mins):