If you havent already you need to try a course of RESTASIS

[dryeyedave]

There seems to be much confusion about RESTASIS. The study in the packaging is misleading. Most later evidence seems to show that it is effective around 50% of the time. Dogs have a 80+ percent response rate to .2 per day. The only small study for SJS indicated that over 80% of those that could complete the study responded to it. I think that the response rate is probably higher than 50% over all and would be even better if .1 2x per day were used.

RESTASIS is the only medicine that has the potential to substantially improve DES. There appears to be a 30% chance that RESTASIS will normalize the condition were only the drug is necessary to maintain lubrication and dosage can be reduced to once per day. In a very small subset (1 to 2%) there is a total cure of of the condition. Starting the drug early in the dry eye process seems to equate to a better outcome.

I have been on it for going on four and a half months and my right eye is near normal and my left eye(my bad one) is continuing to improve. I noticed some improvement one month into treatment and at three months my right eye improved tremendously to the point that my drop usage in that eye went from 10 times per day down to 4 or less. The left eye improved slightly but about two weeks ago( 4 months into treatment) I noticed that my left eye has whiter and less irritated. I also do not wake up with my eyelids stuck to my eye balls any more. My eyes don't feel great in the morning but they are much better. My right eye is also quite tolerant to moving air. I noticed about three days ago that stringy mucus discharge from my left eye has stopped.

My dry eye is from SJS so I am mucin deficient due to goblet cell distruction. The RESTASIS has clearly improved that since that is about all your eyes make at night(support for the studies that show an increase in goblet cells with RESTASIS). My tear production has improved. My lid margins are also now oily. Before I started RESTASIS none of the components of my tear film were working well. So it is improving the overall function of my tear film not just the aquas layer.

RESTASIS is hard to use and it irritates my eyes but I have a protocol which makes it more tolerable. At first I put in one drop of Lotemax about 15 min before the RESTASIS( I did this only with the AM dose). I left the RESTASIS in for 15 min then rinsed out my eyes with UNISOL. I then installed artificial tears. Now, I no longer use the Lotemax but I still only allow the RESTASIS to sit on my eye for 15 min then I rinse it out. I have noticed if I have a redness flare up Pataday stops it with one dose where Lotemax took several applications. I put the RESTAIS in in the morning and at night as close to 12 hours apart as possible. Don't put the RESTASIS on a dry eyeball. I put in a drop of saline before application to wet the eye.

The trays last two months +(I get around 4 to 5 drops per vile). The cost with discounts is around $50 US. So that equates to $25 US per month(less than some artificial tears).

I was told by my pharmacist that RESTASIS is very unstable and to keep in in the tray away from heat above 80 deg F. Under no circumstances was I to put the medication in the refrigerator.

[Guest]

I was told by my pharmacist that RESTASIS is very unstable and to keep in in the tray away from heat above 80 deg F. Under no circumstances was I to put the medication in the refrigerator.

They (pharmacists) have no choice but to tell you not to put it in the fridge, since the manufacturer's recommendation is to store at room temperature. So, I'm certainly not criticizing them for telling you that.

But...

And I only mention this since many of us have found that the only way we could tolerate Restasis in the beginning was to put the vial currently in use in the refrigerator (it stung less when cold) - and now many people may read this and be scared to try putting the vial they are using in the fridge (ie. as a back up plan if they cannot tolerate it at room temp)

Usually, if you have a choice between screwing up on storage of a drug by either overheating it, or overcooling it, the overcooling is less likely to do damage. Chemical reactions that cause drugs to break down typically are sped up by higher temps, and slowed down by cooler temps.

So why doesn't the manufacturer SAY Restasis can be stored in the fridge? Could be that they didn't bother to test if that way, once they knew it was stable at room temp.

Or, granted, maybe they know something we don't. This can be found out though - just call the manufacturer and ask them if they have any data on what happens to Restasis if it's allowed to get refrigerator-cold - you could say your spouse made an error and your vial of Restasis in the fridge for you, and you just want to know if it's still ok to use it. They may have info, or they may say that they don't know since they didn't study that prior or after the drug was approved. If they have not studied what happens to Restasis when it gets refrigerator cold, they will tell you to discard it for liability reasons since they don't want to take a chance that something bad will happen to you from using a cold vial and you will sue them

Next time you go back for your refill, maybe ask that pharmacist WHY they said under no circumstances should you put it in the refrigerator. I suspect the reason will be merely that the manufacturer says to store it at room temp. (and not that they know of some specific bad thing that will happen if you put a vial in the fridge).

Anyhow, I'm really glad to hear it's helping you - that's great news!!!

[DCRdryeye]

Forget RESTASIS, it's not as good as the claims make out. Many people on this forum have been disappointed from the lack of results from it and to get a better perspective of why Restasis is possibly preventing better treatments, go to my new blog I've just written called "EXPOSING THE MYTH OF RESTASIS" at http://australiandryeye.webs.com/app...th-of-restasis

[Guest]

I agree that Restasis is far from a perfect solution, especially for those of us with severe symptoms. However, we are all different, and for some of us, it does make a difference. A person won't know if it helps unless they try it.

[dryeyedave]

DCR:

The information on your link is not accurate. Restatis does not have any black box warnings cyclosporine taken orally does however but those do not apply to Restasis applied topically to the eye. Restasis is undetectable systemically even at up to 6 times the .05% dosage. It does not have the side effects of steroids. It does not cause immuno compromise and there is no increase in ocular infection or adverse effect on the healing process with it. The study of Restasis you mention is from the package insert. The wording is misleading and is not representative of the results of the testing. My data is based on clinical observation from multiple sources regarding its success rate which is freely available all over the net and from my local MDs. The Dog study is particularly interesting since dogs cannot succumb to the placebo effect. My experience is my experience however. The medication has been out for a long time now in the US and evidence is that the only real risk of restasis is it might not work but considering the fact that people with my problem have no options and don't even receive advice because the MDs dont understand the condition I am glad it works for me.

SAAG: I tried the cold Restasis thing and it did not work for me. For me the burning kicks in about 15 min after installation if I dont rinse it out. People can do what they want I am not a pharmacist I was just relaying what mine told me. I figure I will follow her advice but each to his own.

[Guest]

go to my new blog I've just written called "EXPOSING THE MYTH OF RESTASIS" at http://australiandryeye.webs.com/app...th-of-restasis

I noticed that in the article that this link goes to, the article states that "Patients with eye infections should not, therefore, use Restasis. The drug can also elevate blood pressure, which in turn can increase your risk of a stroke or other cardiovascular problems" This gives the impresiong that RESTASIS can do this, when, in fact, it is the active ingredient taken BY MOUTH that can cause this.

Here is the full prescribing information so you can see what I mean: http://www.allergan.com/assets/pdf/restasis_pi.pdf

An elevated risk of stroke or other cardiovascular problems has never been associated with Restasis.

While I'm no fan of drug companies and don't trust them, I thought it was important to point out this discrepancy. You should update the article to state that when the drug is taken BY MOUTH it can do this. Ditto on the black box warnings you reference in the article - those apply to the drug taken by MOUTH, not applied topically as Restasis.

When used only twice per day, the blood levels are negligible. This is not the case when it is used in the high doses as an oral (taken by mouth) medication. So, I wouldn't worry about heart attacks or stroke from Restasis.

However, I admit I am not a fan of cyclosproine since it is indeed a very very, very nasty drug when taken by mouth.

But if you want to point out scary unknowns, I think cancer is another story.... Cyclosporine can raise the risk of certain cancers when taken by mouth. Will it do that to our EYES if used for decades? I don't know - I don't think anyone does. However, it is my understanding that Restasis has been used in Europe much longer than here, so maybe it will be ok... maybe...

Here is a link to the prescribing information for Neoral, an oral form of cyclosporine:
http://www.pharma.us.novartis.com/cs...pdf/neoral.pdf

I have been using Restasis 4 times per day since October 2009. Almost 4 years. At that dose, double the manufacturer's recommendation, there could be detectable cyclosporine in my blood. What that will do to me is unknown. Since it is the dose that makes the poison, it is my HOPE, that this very low amount is not enough to do me harm (it will much, much less compared to someone taking the drug by mouth for example. If I am not able to stop using this medication eventually, I could potentially be using it for another 60 years...

More on "it's the dose that makes the poison"...

Warfarin can either kill you if you take too much of it, or keep you alive by preventing strokes and heart attacks... depends on the dose. Tylenol can either fix your headache, or kill you... depends on the dose.

In any case, I plan on getting off Restasis as soon as I feel my eyes are stable enough to do without it... not because I know for sure it will harm me long term, but because of the unknowns. That being said, I do feel that at 4 times daily, it has helped my eyes get to where they are today - much better than they were back in 2009 when I started.

Pros and cons to everything.

SAAG: I tried the cold Restasis thing and it did not work for me. For me the burning kicks in about 15 min after installation if I dont rinse it out. People can do what they want I am not a pharmacist I was just relaying what mine told me. I figure I will follow her advice but each to his own.

Bummer that the cold thing didn't help you. I hope I didn't sound like I was criticizing... was totally not my intention, since you made it very clear that you were merely passing along what you were told. Sorry if it came across wrong when I posted!!!

[dryeyedave]

I did not take your post as criticism. In fact I suspect you are right that it wont hurt but I really want to get better so I do what I guess I need to. By the way I tried calling the 1800 allergan "help line" to ask about side effects and I found their "help" to be useless.

Have you ever tried putting in one drop of sterile saline just before installing the Restasis? It seems to reduce the side effects especially if you wash out the eye completely after 15 min.

[DCRdryeye]

Yes I wrote 'heart attacks and strokes' with hesitancy. Cyclosporine is the ingredient in Restasis, so whether we call it Restasis or Cyclosporine drops makes no difference. In Australia we have it compounded and call it Cyclosporine drops.

Yes you are correct SAAG, I was referring to the Cyclosporine itself being an immunosuppresant. If it's taken as an oral tablet then obviously it has serious side effects including cancer. However, applying it to the eye topically, will probably not enter the blood stream. However, applying 4 times a day, as you said, may cause a very low amount to reach your blood stream. Such a low amount may not be causing any harm. I just hope the miniscule amount in your body isn't causing any damage to genes that regulate cell division. Drugs, even in small amounts are powerful substances.

I do have a concern of placing such a potent drug on the eyeball itself. Blood vessels exist on the conjunctiva and yes, Restasis has been around since 2002 with a good safety record. Having said that, it can take up to 20 yrs for serious side effects to kick in. For eg: If you take Lithium for 20 yrs you'll need dialysis (it totally destroys the kidney tubules).

Real feedback, from real people whom have been disappointed with Restasis is the best way to make a decision, not from pharmaceutical companies boasting how Restasis "produces natural tears" with their strong and persuasive advertising campaigns. Another thing to consider is the price, is the price to benefit ratio balanced?

I've tried Restasis for 12 months, it did nothing, just made my eyes burn more. I tried it at 4 times a day as recommended and couldn't handle that since it made my eyes red and burn all day. Two times a day was enough.

I'm glad Restasis is working for you dryeyedave. My main point is that it's a potent drug, and if you've read hank9 (another member here and a colleague of www.australiandryeye.webs.com) conspiracy theory about artificial tears you may get a glimpse into our perspective. Basically no artificial tear on the market replicates natural tears, thus causing possible long term damage. There was a post on an ingredient in artificial tears that can cause damage. Whilst we have no choice to use them, there is research being conducted (but lack funds) to identify 400+ peptides in tears. Hopefully a drop can be made from it. Stem cell research on Lacrimal glands is being conducted. And why is RESTASIS the only FDA approved ophthalmic drug to 'supposedly' stimulate tears on the market in 12 years? Profit to be made. Enough ranting.

[Guest]

I did not take your post as criticism.

Whew! That's good!

In fact I suspect you are right that it wont hurt but I really want to get better so I do what I guess I need to.

Same here... sometimes in the short term you have to do things you'd rather not. So for now, like you, I continue with Restasis. I'm hoping that with enough time of it's suppressing inflammation that my eyes will end up doing more and more until they finally reach a tipping point where they can do what they need to do on their own, without having Restasis on board... we'll see.

By the way I tried calling the 1800 allergan "help line" to ask about side effects and I found their "help" to be useless.

Due to my job, I always end up using the Health Professionals Line when asking wanting more info about a drug from the manufacturer, so I guess they give more info there compared to what they give to laypeople. Kind of a bummer though, since many laypeople would appreciate the extra info. That being said, I don't recall if I've ever called Allergan about Restasis... so who knows...

Have you ever tried putting in one drop of sterile saline just before installing the Restasis? It seems to reduce the side effects especially if you wash out the eye completely after 15 min.

Not quite, but what I used to do (for months, maybe even the first year), was 15 minutes prior to instilling Restasis, I'd use a drop of artificial tear so my eye wouldn't be completely bone dry when it was time to put in the Restasis. This I no longer need to do since I don't often get that totally bone dry feeling with my current routine.

However, what I do still have to do, in order to prevent burning lasting for hours, is 15 minutes after using Restasis, I shut my eyes tight and flush my eyelashes with water under the tap, to rinse away any Restasis residue.

Also something I used to do, but no longer need to do, is back in those first few months or first year, since my eyes made practically no tears, there was nothing to "rinse out" the Restasis from my eye afterwards - so I'd do this artificially by using a few drops of artificial tears in each eye about 15 minutes after instilling Restasis to flush it out. This also used to be a crucial step to me to prevent burning lasting for hours afterwards.

Lastly, although some on this forum put Restasis in before bedtime, I make sure to this day that my last dose of Restasis is at least a couple of hours before I go to bed. If I put it in too close to bedtime, whatever small amount will be left in my eyes will lead to totally bloodshot eyes the next morning, lasting all day at times.

So much trouble to go through, but I felt like if there was anything I could do to get enough of the anti-inflammatory effects from it, without the irritating effect of the drug itself overwhelming any positive effects, it was worth it.

My theory on Restasis: While cyclosporine is a useful anti-inflammatory, the big problem with this formulation, that decreases the efficacy to such a low level, is that the formulation itself is so irritating that in those with severe dry eyes the miniscule amount of tears they DO make is not enough to dilute the irritating Restasis solution after application. The resulting inflammation from the irritating solution is often MORE than what the drug in that same solution fixes. So the irritating formula itself causes inflammation that counteracts the anti-inflammatory effect... Again, this is just my theory...

People I've seen on it that have normal run-of-the-mill dry eyes are often thrilled with it - and let's face it, most dry eye patients that ophthamologists see have normal run-of-the-mill dry eyes, so it's no wonder that many dr's think this drug is super effective - I knew a woman who went on it before I did and she had eyes that were dry enough that she couldn't wear contacts, her eyes bothered her non-stop during the day, but still nowhere near as bad as MY dry eyes are (ha, I'm a freak, after all lol). She went on Restasis, and within 2 months was NORMAL. She was ecstatic. Her redness was gone, her eyes were no longer dry, she could wear eye makeup again - to her, this was a miracle drug. I'm not sure how long after that she continued with it... might still be on it for all I know.

[hankm9]

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[DCRdryeye]

Perspective and Clarification

Thanks for clarifying my blog with more detail hank. What worries me is members here pick all the bad points, or mistakes, but not one had understood the message behind it. We are not here to angst anyone, we get to the point and again, RESTASIS does have it's problems and is NOT the magic bullet it's claimed to be. We are here to assist members and carve new pathways for significant better treatment or a near cure for dry eyes and MGD. We all suffer from it, lets stick together and make some real progress.

Please be more supportive and positive.

[dryeyedave]

DCR and hankm9:

I am glad you two are passionate but you are not being supportive at all by spreading opinion that I think is not helpful to people who come here for answers and options, and with all due respect you have no basis for most of your claims. I took my time to post this tread to be helpful and to try to answer for others the questions that were never answered for me and I really don't like my thread hijacked with your opinions that have nothing to do with the recitation of my experience. I am shilling nothing.

An example is the AARP site which is again cited as a viable source when it is the same one stating Restasis has multiple black box warnings which it doesn't. Multiple trials and in years of clinical use for a host of conditions including dry eye have proven just the opposite that Restasis does not increase the incidence of infection nor does it slow or delay healing(it is now used to treat recurrent herpes infections of the eye). Any statement of how the drug actually works is theory only not fact or proof as you present it since the method of action is for now unknown. If you doubt the effectiveness of the drug I would direct you to dog studies and the success that this drug has had in veterinary medicine.

I agree we need more options and for God's sake a cure. However, your Lacritin drug is not available any where and is not a treatment option in the US at this time so your argument is quite frankly moot. What you might not know is that the US FDA approval process for eye medications is extremely costly and difficult. That is why most rewetting drops all contain the same basic ingredients and why so many new promising drugs never make it to market and why many new rewetting drops either are not approved or are ultimately recalled(as happened with Bausch & Lomb's lipid drop and vita drops). It is not some dark big pharma conspiracy to cause suffering. Also many apparently promising drugs fail in clinical trials when actually tested beyond a hand full of subjects.

If you read Restasis experiences here carefully you will see that most people do derive some benefit from it and are improved they are just not cured but then again the drug was never touted as a cure. I say all of this because as you know people are upset and frustrated with this condition and need answers not dogmatic opinion. I need answers and solutions now. I vacillated about the drug because of the inaccurate BS that is on the net about the drug until I dug deeper and saw how effective it can be. Quite frankly when I read the post here it increased my confusion. Bottom line Restasis has worked for my condition which if you research SJS is very grim with little hope of improvement. I stand a 40% chance of future blindness from ultimate stem cell failure and corneal melting. I don't have years to hope for a pie in the sky cure.

Lastly I doubt any drop no matter what it is made of will cure this condition. It is multifaceted and complex. The underlying causes are still largely unknown. Since much dry eye appears to be caused by long or short term tissue damage(as mine is) in some form I think that only adult stem cell regeneration of the ocular service and surrounding tissues will ever cure this condition.

I hope someone who is suffering benefits from my thread in some way.

[NotADryEye]

dryeyedave, it's great that you are finding relief with Restasis. However, Restasis did not help me at all. I was on it for 5 months. From Restasis I had only extreme pain. The pain was so severe that I spoke with the Restasis safety department and also reported the pain to the FDA. But it is absolutely terrifc that you are finding relief with Restasis. It's just not for me or others like me, and there are many of us.

In the beginning, when we find ourselves with the Severe Dry Eye diagnosis, I think we all are looking for a magic bullet and a cure-all. We don't really know any better. And so the marketers at big Pharma, knowing how vulnerable we are and how much we want a magic bullet cure-all, market their treatments as if they were exactly that. They give us false hope and in the process make a lot of money. That is the travesty.

Eventually we learn that the disease is much more complex, with numerous possible co-morbidities, and treatment needs to be nuanced and customized for each patient individually. Each of us will have our own set of diseases and well as our own responses to these treatments.

Fundamentally, we do need better and more effective treatments, better research and less of these false claims of cure-alls from marketers who sell to our vulnerabilities.

[DCRdryeye]

Dryeyedave - We never meant to hijack your thread. We've just known people whom have been on and off Restasis since 2002. The black box warning was meant for cyclosporine tablets, so that was a mistake on the blog if it referred to Restasis, we will ammend that.
We aren't all opinion, but quiet the opposite, you'll notice hankm9 often provides links to trustworthy research.
Do you have SJS dave? I sympathize with you, it's a terrible disease and yes you'll be looking for anything you can find that is available now. Have you tried Prokera (amniotic membrane) ? In fact, there is a drop based on it and we are trying to obtain it, it's called AMX and could significantly benefit your condition.
Australia's regulation system for medicines is also very strict and costly, very draconian and known as the toughest in the world. We don't even have Restasis listed, and it's been available in the USA since 2002. We must see specialized ECP's and have it compounded.

Furthermore, you mentioned 'stem cells'. We are working on a fundraising project to assist a researcher working on stem cells for the Lacrimal glands, along with other research (eg: Lacritin, a Statin drop, studies into the components of real human tears 400+ peptides, etc). We know many never make past phase 3 of trials, and this is something we'll look at solving too, especially if some big pharma is preventing it from passing due to competition. As Hankm9 said, the cures are already there in laboratories, they just need funding and since dry eye is trivialized along with many other barriers, research dollars are lacking.

Check out these options if you haven't already done so. Hankm9 may throw in some more ideas for you.

All the very best.

[hankm9]

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