Navigation Links
FDA Grants NeoVista's Request to Expand CABERNET Trial to 30 Sites in the U.S.

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

Contact: Tony Moses

O: 510.933.7600

C: 510.402.3394

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:
(Date:11/26/2015)... 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in the ... Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new 247-page ... therapeutic drug monitoring market, including emerging tests, technologies, ...
(Date:11/25/2015)... SYDNEY , Nov. 26, 2015  The total global ... nearly 7% over 2015-2016. Latin America ... Asia , (excluding Japan ), is ... continues to face increased healthcare expenditure. In 2013-2014, ... expenditure declined from 43.5% in 2008-2009 to 41.2% in 2013-2014. ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma Services ... investment of at least $15.8  Million to expand ... Wilmington, NC . The expansion will provide ... meet the growing demands of the pharmaceutical and ... site expansion will provide up to 40,000 square ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Dental professionals who would ... OH , are invited to attend Dr. Mark Iacobelli’s Advanced Implant Mentoring (AIM) CE ... Cleveland, OH. , As the co-founders of Advanced Implant Mentoring (AIM), Dr. Iacobelli ...
(Date:11/25/2015)... ... November 25, 2015 , ... The McHenry County law firm of Botto ... by Attorneys Francisco J. Botto and Alex C. Wimmer. Attorneys Botto and Wimmer represented ... IL App (2d) 130884WC. , According to court documents, Adcock testified that on May ...
(Date:11/25/2015)... ... ... SCOTTSDALE, AZ) - Today, Dr. Todd C. Hobgood ... non-surgical treatments, announced the expansion of his private practice capabilities with the grand ... trained and nationally recognized for his natural approach, Dr. Todd Hobgood serves the ...
(Date:11/25/2015)... ... 2015 , ... In an ongoing Clinical Study conducted by an independent physician, ... Angel is evaluating the efficacy of its product and its disinfection protocol. This study ... from May 2014 through October 2015 at a 360-bed, acute-care, academic medical center located ...
(Date:11/25/2015)... ... November 25, 2015 , ... Castlewood ... people struggling with eating disorders as a result of the $20,000 raised at ... held at Fox Run Golf Club in Eureka, will help individuals who otherwise ...
Breaking Medicine News(10 mins):