Durezol study for anterior uveitis

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Mike Bartolatz
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Durezol study for anterior uveitis

Post by Mike Bartolatz » Thu Dec 11, 2008 8:09 pm

http://www.bio-medicine.org/medicine-te ... 29-3288-1/

this new corticosteroid only requires half the doses a day to of Predforte from the latest study of this FDA approved drug.
it does NOT contain the preservative in Predforte which can lead to corneal toxicity and medicamentosa, an allergic reaction to preservative in eyedrops.

it is suggested for those that require long term use of corticosteroids such as those with recurrent or chronic uveitis.
a comment from C Stephen Foster MD is included in this article with an abstract of research he did on it.
it is pretty expensive however.

wishing all the very best,
Mike
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Mike Bartolatz
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Re: Durezol study for anterior uveitis

Post by Mike Bartolatz » Thu Jan 22, 2009 8:18 pm

http://www.rdcdrug.com/news.asp?rc=news&iNav=2&news=134

durazol used 4 times a day as effective as predforte 8 times a day.

see original study above this post
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Mike Bartolatz
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Re: Durezol study for anterior uveitis

Post by Mike Bartolatz » Thu Apr 02, 2009 12:41 pm

Dear Mike,

I am a co-founder in Sirion Therapeutics, Inc, the company thay recently got Durezol approved and on the market. I am the head of sales and marketing and I was looking at the posts on this site. It looks like you moderate most of the information and discussions. I was wondering if you would like to be put on our list to receive all updates related to Durezol (press releases, clinical trial data, FDA reviews, etc.)?

I was reading some of the information and posts on Durezol and thought that I would send you an update on Sirion and Durezol. While we (Sirion) have good insurance coverage for Durezol, we still have some work to do since the drug is so new (approved June 2008). We have supplied doctors with co-pay assitiance cards to help patients with their out of pocket costs. Nationally, our co-pay is averaging $35 after the co-pay assistance card. The doctor gives the discount card to the patient when they write the prescription. The pharmacy discounts the co-pay amount right at the time of prescription fill/pay (no need to mail anything or do any extra work to get the discount). Also, we do have a patient assistance program for those patients that cannot afford Durezol or do not have insurance coverage.

If I can be of any help or you would like for me to put you on our list for medical communications as it relates to Durezol, I would be happy to do that. If not, I understand.

All my best,

Susan Benton
Sirion Therapeutics, Inc.
813-496-7325 ext 226
Mike Bartolatz
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Mike Bartolatz
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Re: Durezol study for anterior uveitis

Post by Mike Bartolatz » Thu Apr 02, 2009 12:57 pm

I indicated to her in private message that Yes we are interested in updates on Durezol. I told her she could post them here or I can, the main thing is that all with uveitis know that there is help with copay and humanitarian assistance through the maker for the drug.

mike
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Ralph
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Re: Durezol study for anterior uveitis

Post by Ralph » Fri Apr 03, 2009 5:45 pm

Susan,
I would like to personally thank you for bringing this drug to market. I am nothing short of amazed at the results.

viewtopic.php?f=3&t=3298#p10021

Regards,
Ralph Stefan

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Re: Durezol study for anterior uveitis

Post by Mike Bartolatz » Fri Apr 03, 2009 6:32 pm

Ralph,
tzigbent@verizon.net <zigbent@verizon.net> you can EMAIL her your testimonial. she can then send you coupons to your doctor for discount of co-pay of insurance or set you up to help pay for the meds if you pay out of pocket.

thank you for your input in your other post as it heartens me when something good comes around for us that WORKS.

wishing you the very best,
mike
Mike Bartolatz
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Mike Bartolatz
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Re: Durezol study for anterior uveitis

Post by Mike Bartolatz » Thu Apr 09, 2009 8:51 am

Dear Mike,



Thank you for your message. I signed up for the website and sent you a private email until I could understand the rules for the website. I did not want to overstep my bounds or be “commercial” about our drug since I am a co-founder in the company and head of sales and marketing. My interest purely in helping people understand that there is a new and better option available to them now instead of Pred Forte that has been around for 35 years.



Our new drug, Durezol (difluprednate ophthalmic emulsion 0.05%), was approved on June 23, 2008 by the Food & Drug Administration for the treatment of inflammation and pain associated with ocular surgery. It is a corticosteroid like other steroids you may be familiar with such as Pred Forte, Lotemax, FML, Omnipred or the generic which is the most commonly dispensed drug at the pharmacy, generic prednisolone acetate suspension 1%. We (Sirion) funded a head to head clinical study against Pred Forte (the branded drug not the generic) for the treatment of uveitis and have since filed a supplemental new drug application in December of 2008 for a uveitis indication. What we know about Durezol from the extensive clinical studies that were done in Japan and here in the U.S. is that Durezol is at least twice as effective as Pred Forte with half the doses. In our head to head uveitis trial, Pred Forte was dosed 8 times per day and Durezol was dosed 4 times per day and we achieved better clinical efficacy. The most inflamed eyes (grade 4 inflammation meaning 50 or more cells in the anterior chamber) responds well to QID dosing and resolves inflammation in as few as a few days to within two weeks. Also in that study, 12.5% of patients failed on Pred Forte and had to be rescued with 16 times a day dosing of Pred Forte. There were no treatment failures in the Durezol arm of the trial. This is very exciting research and brings hope to everyone that uveitis touches. Our hope is to advance treatment so that people with uveitis can take fewer drops for a shorter period of time and quiet their eye and help doctors get people better faster.



Many uveitis specialists are using our drug already because of the better clinical efficacy. The other thing they love about our product is that it is an emulsion and does not require shaking like pred forte and other steroid suspensions. Durezol does not contain BAK (benzalkonium chloride with can cause corneal toxicity especially with long term and chronic use drops). Durezol is preserved with a sorbic acid a non-toxic preservative.



Since our drug has become available some of the uveitis doctors are studying Durezol to see if it can get to the back of the eye. In our animal studies, Durezol levels were measured in the back of the eye (Pred Forte does not get to the back of the eye). The doctors are looking at OCTs to look at macula thickening as a measure of the drug getting to the back of the eye from a clinical/diagnostic point of view. Dr Foster was in our study and just wrote an article regarding Durezol and his clinical experience using the product. I will send the article to you. It was published in Ophthalmology Times two weeks ago. I do not know where you are located but many of the uveitis specialists are adopting Durezol as their standard of care to treat uveitis since it works so much better than Pred Forte.



Because we have only had the drug on the market for a little over 6 months we are working hard to get the drug covered on managed care formularies. For cash paying patients, Durezol will cost $100 for a 5mL bottle at the local pharmacy. For people with insurance, it will cost a co-payment. We have made $10 co-pay assistance cards available to the ophthalmologists. Right now, our average co-pay on commercial insurance is $35 after the $10 card. If someone cannot afford Durezol, we have a patient assistance program and we provide up to 3 bottles free to the patient through their doctor. We want to do everything we can to help people get the drugs they need the most affordable way possible.



I will keep you up to date on what we are doing and our clinical science since I know you have a personal interest.



All my best,



Susan Benton

Co-Founder, SVP Marketing and Sales

Sirion Therapeutics, Inc.

www.siriontherapeutics.com

www.durezol.com

813-496-7325 ext 226
Mike Bartolatz
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Mike Bartolatz
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Re: Durezol study for anterior uveitis

Post by Mike Bartolatz » Tue Apr 14, 2009 4:54 pm

http://durezol.com/TempPDFs/Durezol_PI_Sept_08_Web.pdf




http://www.iritis.org/pdf/Donnenfeld.pdf
http://www.iritis.org/pdf/Foster.pdf
http://www.iritis.org/pdf/Holland.pdf
http://www.iritis.org/pdf/Osher_top_products.pdf
http://www.iritis.org/pdf/OT-3-15-Silverstein.pdf


Above you will find links to PDF files which contain discussion about use and efficacy of Durezol as well a prescribing information in the First file at the top of the page
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lattemochachino
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Re: Durezol study for anterior uveitis

Post by lattemochachino » Fri May 01, 2009 1:21 pm

I just began Durezol this morning. I had to special order it from my pharmacy so would have started it sooner if I could. I spent 4 weeks on Pred Forte and two courses of Solumedrol - and no response. My ophthalmologist said in 16 years he has never had a case not clear up with the above treatment. I am praying Durezol will be the answer.

Can more info be provided on copay help and or sample info? I have insurance but Durezol was still pretty expensive with my copay - and since it appears I may have repeat bouts of iritis I would love to have access to samples or copay coupons.

Thanks!

Mike Bartolatz
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Re: Durezol study for anterior uveitis

Post by Mike Bartolatz » Fri May 01, 2009 8:33 pm

813-496-7325 ext 226
call Sirion , Susan Benton and ask her to send the 'coupon' for the ten dollar copay to your opthalmologist to give you. I think it has to be filled in by the opthalmologist then given to either the pharmacy or sent direcly by you to Sirion and they might reimburse you.

are you seeing an Ocular Immunologist as you may require a differnt type of medicine all together such as Methotrexate, Cellcept alone or in combination with other drugs to retrain your immune system to stop attacking your eyes.

wishing you the very best,
Mike Bartolatz
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