Why is Restasis our only option

[Joseph]

Here we are in 2012 and the best thing out there is an eye drop that is over priced and from what I have read has little if any benefits. Even when I asked my eye doctor about Restasis he said that he feels that most people do not see much of an improvement and that they are not worth a try.. I know some of you have been helped by this drop but how could this be it. VENTING I GUESS...

[jax8it]

I completely agree. I have been on Restasis for a little over a month now. I know I will not see any effects for two or three more months. Yet, most people it seems do not see any effects. Is there anything in development that could possibly help us?

[Súil Eile]

It's even worse for those of us in countries that don't have restasis or access to pharmacies which can make it. My vet could prescribe it for my dog,but my opth can't prescribe it for me...madness!

It's very frustrating to be part of a patient group that just has to make do and persevere

[Rebecca Petris]

Here we are in 2012 and the best thing out there is an eye drop that is over priced and from what I have read has little if any benefits.

This is a really important question. The answer:

Because it is virtually impossible to get a dry eye drug approved by the FDA. Seriously! Complain to the FDA and your lawmakers!

Even with the standards a decade ago, Restasis failed several times before approval. If Restasis had to go through the CURRENT standards, it would never be approved. (Whether it deserved to be or not is another question, LOL... won't address that here.) The bottom line is the combination of improvements to clinical signs and symptoms that are required for approval. As we all know, there is simply not a predictable relationship between the two. Drug makers have invested so much in dry eye drugs that did not perform well enough to have any hope of approval by current standards that they are now skipping the US market altogether. This is not good.

[Joseph]

WOW.. That is exactly what my doctor said. Almost word for word. He said that there are alot of drugs that are better for dry eyes then Restasis but the FDA keeps shooting them down. He is on a research team for new drugs for dry eyes and said it is very frustrating.

[littlemermaid]

But do we think that we can't control chronic inflammation on cyclosporine where there is, say, an autoimmune component? I was hoping to wean off chronic steroid use onto formulated PF Restasis to avoid difficult cataracts. Some people with ocular rosacea seem good on Restasis.

Suil Eile, You might be able to get Optimmune (Moorfields), it's the dog stuff approved for humans.

[Súil Eile]

Thank you so much for that LM! I'm definitely going to look into that.

[Rebecca Petris]

But do we think that we can't control chronic inflammation on cyclosporine where there is, say, an autoimmune component?... Some people with ocular rosacea seem good on Restasis.

Appears so:

Surv Ophthalmol. 2009 May-Jun;54(3):321-38.
Topical ophthalmic cyclosporine: pharmacology and clinical uses.
Donnenfeld E, Pflugfelder SC.
Ophthalmic Consultants of Long Island and Connecticut, Rockville Centre, New York 11570, USA. eddoph@aol.com

Abstract
Cyclosporine has been used successfully as a systemic immunomodulator for more than two decades, and numerous studies have investigated its mechanisms of action. In 2003 an ophthalmic formulation, cyclosporine 0.05% ophthalmic emulsion, was approved by the FDA to treat dry eye disease. Topical cyclosporine emulsion has also been investigated for treatment of other ocular surface disorders that may have an immune-based inflammatory component. In these trials, cyclosporine 0.05% ophthalmic emulsion has shown efficacy for management of posterior blepharitis, ocular rosacea, post-LASIK dry eye, contact lens intolerance, atopic keratoconjunctivitis, graft-versus-host disease, and herpetic stromal keratitis. As these disorders are often refractory to other available treatments, ophthalmic cyclosporine is a welcome nontoxic adjunct or replacement to potentially toxic topical or systemic immunosuppressive therapies.

Much as I love to hate Restasis, fact is, I know a lot of people who have benefitted, and on a board that collects people who are exceptions to every rule, that alone says something.

[sazy123]

Sui ellie, you can buy restasis on the intenet from www.edrugnet.com without a rx. I have done this and know many others have gone down this route.

[poppy]

Sazy123, this conversation is probably going to get moderated anyway, but... edrugnet.com is DOWN at least here in Australia and has been for some time. I don't know if the whole business has been shut down or if its just being blocked locally.

[sazy123]

Oh really? is there any other pharmacies you can check that are still running. As far as i was aware it is legal, maybe they are trading under a different name. It would be worth doing some research to see.

Thats interesting. Im living in the US right now and i am going to make use of treatments while im here and seeing doctors- becuase i have really good health inursance. Not that i think it will do any good because ive tried eveyrthing and there really isnt much else they can do for me right now.

I completely understand the frustration regarding restasis!!! it is very ineffective for the majority (mainly those with MGD), but they tout it for everyone, and theres much better drugs and formulations being tested than restasis- which would probally help far more people and they cant get them approved!!! its ridiculous!!!

Didn't experts meet with the FDA to discuss different end points for dry eye research to make approval easier? What did they come up with?

They arent going to find a drug that helps thew majority of dry eye patients (like say allergies) but with different arsenal of drugs approved that treat different types of dry eye- most of us would bennifit!

[poppy]

Hi sazy123,

My understanding is; edrugnet.com is/was legal in it's own country (Thailand I believe). However if you import drugs via mail order, the rules differ depending on the country in which you live. Just because it is legal in Thailand for them to sell it to you, doesn't mean it's legal for you to import it. Generally, importing drugs via mail order that would normally be prescription drugs in your country, requires a prescription from a doctor in your country. Otherwise, the drugs can be seized by customs, you may get a fine, etc. However, if you purchase drugs whilst travelling overseas without prescription (in accordance to the laws of that country), and bring them back with you on your person to your home country for your own personal use or the use of your immediate family, and the quantity is small, this is generally legal even if that drug would normally require a prescription in your country. Obvious exceptions to this rule are controlled substances, illegal drugs, drugs likely to be abused, etc.

I don't intend to get the moderators upset with the above post. I do believe my comments reflect the legal situation for many people wishing to bring medications into their country which they can't obtain otherwise. Of course you have to check the exact rules for your situation before doing so.

[Joseph]

From what I have read on the (Dry Eye Digest) blog there is a bunch of new stuff that looks promising and might come out sooner then later. I know that like anything else it all boils down to how much money can be made from the new product. That might be the good news to all of this because with dry eye becoming more prevalent each year the money will be the motivation to get more products on the market..

[dryeye4ever]

Yes i guess its more prevalent, there are millions of people waiting to have better lives. I went to ophta twice (i live in quebec) and restasis isnt even an option just '' drops ''. If i ever heal from this i will be healthy and in great form once again! Lets cross our fingers but work on nutrition too.

[macio1981]

I was thinking about trying Restasis but I hear so many negative reports about it being pretty useless. The biq question for me is: What is the best eye drop? I use standard Theratears but is there a drop which lasts longer, doesnt irritate? There are a million different drops but can anyone reccommend something as good as Theratears that lasts longer? The worst thing for me is morning dryness....this is the thing that I wish I could treat the most. I dont use a drop before bed because everything seems to just make me worse the following day? Argh!!! Richard.