NeoVista Presents One-Year Study Results of Novel Therapy for Treatment of Neovascular Age-Related Macular Degeneration

NeoVista, Inc. made public today at the American Academy of Ophthalmology meeting the company’s one-year results from their MERITAGE Study. This study was designed to examine NeoVista’s novel Epimacular Brachytherapy procedure when used in patients who require chronic therapy with anti-VEGF agents on an ongoing basis to control Neovascular Age-Related Macular Degeneration (Wet AMD). The study enrolled patients who had as many as 38 prior injections of anti-VEGF therapy before receiving Epimacular Brachytherapy. The study population had a trend toward losing vision, even with regular anti-VEGF therapy in the year prior to enrollment. Prior to entry into the study, all patients were required to have received a loading dose of 3 monthly anti-VEGF injections and then a minimum of 5 additional injections in the 12 months preceding enrollment or 3 injections in the 6 months preceding enrollment. This ensured that the full benefit of anti-VEGF therapy was realized prior to entry into the study.

Study results (n=53) to date suggest that a single procedure of Epimacular Brachytherapy can stabilize visual acuity in a majority of this patient population (79%) while decreasing the number of anti-VEGF injections required. Most importantly, 47% of patients enrolled in the study experienced some improvement in their visual acuity while 10% of patients gained 15 or more letters of visual acuity at 12 months. This improvement is significant in patients that have been receiving chronic anti-VEGF treatment with no vision improvement in the year prior to enrollment, as compared to all other trials that are treating patients with newly onset disease.

The study results also pointed to a favorable trend with respect to a reduced number of anti-VEGF injections following delivery of Epimacular Brachytherapy (mean of 3.9) versus the period of time leading up to Epimacular Brachytherapy intervention (mean of 12.3). In addition, 25% of patients remained injection-free at 12 months following the Epimacular Brachytherapy procedure.

“MERITAGE is the first of its kind study designed to evaluate the potential role of the NeoVista device in treating chronic disease and decreasing the 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 anti-VEGF treatment on an ongoing basis for an indefinite period of time. We are very excited that our procedure, Epimacular Brachytherapy, not only has the potential to significantly decrease the number of injections administered but may also improve visual acuity in a significant percentage of this patient population.”

In contrast to other forms of radiation therapy for Neovascular AMD, NeoVista’s approach delivers a focused dose of energy directly to the wet AMD 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 and highly controlled to a local area. The effective dose to the entire body from NeoVista’s device is less than that from a typical chest x-ray. There were a limited number of adverse events in the trial, which were related to the surgical vitrectomy procedure, rather than Epimacular Brachytherapy.

The MERITAGE Study was conducted in two centers in the Unites States, one center in the United Kingdom, and two centers in Israel. Principal investigators were Pravin U. Dugel (USA), Michael D. Bennett (USA), Timothy L. Jackson (UK), Adiel Barack (Israel), and Dov Weinberger (Israel). The data was presented by Pravin Dugel, MD, managing partner, Retinal Consultants of Arizona, Phoenix, AZ. “The potential of this treatment is enormous,” said Dr. Dugel, “as this patient population represents the majority of patients that I see in my clinic each and every day. I believe that Epimacular Brachytherapy, unlike anti-VEGF therapy alone, offers a broad spectrum of activity and may therefore inhibit multiple disease processes involved in the pathology of wet AMD. To observe not only a reduction in treatment burden, but also an improvement in visual acuity in almost half of these difficult to treat patients at the one year mark is quite encouraging.”

NeoVista 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 490 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.

A second pivotal trial MERLOT (Macular EpiRetinal Brachytherapy versus Lucentis® Only Treatment), sponsored by King’s College Hospital, London, England, (Principal Investigator-Mr. Tim Jackson), is being conducted in 20 centers throughout the United Kingdom. MERLOT is also a randomized, controlled study, with targeted patient enrollment of 363 subjects. This study is analyzing the effects of Epimacular Brachytherapy used concomitantly with as needed Lucentis injections versus continued Lucentis therapy alone, in patients who require chronic therapy with anti-VEGF agents on an ongoing basis to control Wet AMD.

About NeoVista, Inc.

NeoVista, Inc. is a privately held medical device company based in Newark, California. The company’s first commercial product, VIDION® ANV® Therapy System, is cleared for commercial use in all markets that accept a CE Mark.

For more information about the company, or this novel therapy, please visit the company’s Web site at www.neovistainc.com.

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Movie: Twelve Kingdoms – Chapter 7 – Reflection http://bit.ly/9KqKJi – by kitanoau (Kitano Holdings P/L)

The Twelve Kingdoms episode 39-1 (Audio English) /45

The Twelve Kingdoms episode 39-1 (Audio English) /45
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Tagged as: AgeRelated, Degeneration, Macular, Neovascular, NeoVista, novel, OneYear, presents..., results, Study, Therapy, Treatment

{ 25 comments… read them below or add one }

MrJustletmeseeit October 16, 2010 at 12:39 AM

@gr8Sweetfox Ok, what if we stuff the nuke with pixies and unicorns?

Reply
gr8Sweetfox October 16, 2010 at 1:23 AM

@MrJustletmeseeit that wouldnt happen. at least the trees.. i mean this special trees are never affected.. they seem to be impossible to destroy

Reply
MrJustletmeseeit October 16, 2010 at 1:55 AM

@gr8Sweetfox what if the nuke slips thru and detonates while tentei is yawning? or getting it on with some hot goddess…

Reply
RokenMusic October 16, 2010 at 1:56 AM

@gr8Sweetfox As for your question about the princess’s palace song. I do not believe an official attempt of dubbing it into English was ever made. There might be fan made videos floating out there. I recommend you search the first line of the song’s lyrics for these. Good luck.

Reply
RokenMusic October 16, 2010 at 2:33 AM

@gr8Sweetfox 12 Kingdoms is very unique in that it is what I would like to call “a Fantasy Opera”, in which the characters are vivid and the central storyline lives within an epic world of continuous stories. This kind of anime are very hard sells because it requires the anime studios to invest heavily and risk utter failure. However, there are a few out there that are on similar caliber. One is Legend of Galactic Heroes. Unfortunately it is science fiction rather than fantasy.

Reply
gr8Sweetfox October 16, 2010 at 3:00 AM

@RokenMusic something like 12 kingdoms with anime?
ps, you were fast. And maybe you know something about the english dubbed version of Sho something. You know that song about a doll… maybe you know something i want it in english so badly ugh i would even pay for it ;__;

Reply
RokenMusic October 16, 2010 at 3:29 AM

@gr8Sweetfox EVA: Neon Genesis Evangelion
LoGH: Legend of Galactic Heroes
Ronin Kenshin
Cowboy Bebop
Trigun
Black Lagoon
and the list goes on depending on your tastes.

Reply
gr8Sweetfox October 16, 2010 at 3:58 AM

@RokenMusic ok , what is EVA, LoGH, and etc. ?

Reply
gr8Sweetfox October 16, 2010 at 4:49 AM

@MrJustletmeseeit nah it would not. Tentei protects their world.

Reply
MrJustletmeseeit October 16, 2010 at 5:16 AM

man… one of todays nukes would take that whole world out =(((

Reply
maihoua19 October 16, 2010 at 6:01 AM

i always felt exciting watching this movie and love it

Reply
endlesssonata October 16, 2010 at 6:25 AM

I love all the Oooohhhh and Aaaahhhhh. So freaking cool!

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endlesssonata October 16, 2010 at 6:55 AM

WOW this one is my favorite ep ever! Youko’s entre is soooo coolll. Now that IS how a queen reveal herself!

Reply
Goatmon October 16, 2010 at 7:43 AM

Youko is the boss, and she’s layin’ down the law.

Reply
Goatmon October 16, 2010 at 7:49 AM

@chebozz Fantasy/Adventure?

Reply
ZRaya99 October 16, 2010 at 8:27 AM

i like how they all laught

Reply
enariuzai October 16, 2010 at 8:51 AM

早く続きが観たいです、続編が再開されたみたいだし＾＾

Reply
afny19 October 16, 2010 at 9:11 AM

if the real world have ruler like this, this world can be a better place… so wise and noble even if that person use to be just a commoner ^^,

Reply
brokenating October 16, 2010 at 10:00 AM

i really love this episode! :D

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zeroEDJE October 16, 2010 at 10:08 AM

For a second there I thought we were going to see the intro.

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chebozz October 16, 2010 at 10:33 AM

hmmm…what is the genre of this anime??

Reply
mancdg627aol October 16, 2010 at 11:26 AM

I love watching this episode over and over again it’s so cool when keiki showed up and youko questioned general jinrai hahaha… The best anime i watched on its genre… I will buy the books an read it…. ^^

Reply
RokenMusic October 16, 2010 at 12:05 PM

@gabaroo59: No, not really. Twelve kingdoms is one of the best light novel series and anime series. Up there with EVA, LoGH, and etc.

I’m surprised that they didn’t do a half bad job at dubbing this anime. The translation is pretty accurate to the original. Although Yoko’s voice is supposed to be more boyish.

Reply
bollywoodgirl21 October 16, 2010 at 12:16 PM

I love yokos speach in the beginning, she just rules!!!

Reply
tearsangelz October 16, 2010 at 12:54 PM

i totally agree<3 all the beasts in this anime is just so awesome!

Reply

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