September 1, 2011

Does Restasis work?

Details about restatis

See this PDF article. [Also this]

Restasis (cyclosporine ophthalmic emulsion) is the only prescription product for chronic dry eyes. Approved by the Food and Drug Administration in 2002, the drug increases tear production, which may be reduced because of inflammation on the eye surface. In a clinical trial involving 1,200 people, Restasis increased tear production in 15 percent of patients, compared with 5 percent of patients in the placebo group, says Wiley Chambers, M.D., deputy director of the FDA's Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products.

Restasis is usually given twice a day, 12 hours apart. It should not be used by people with eye infections or hypersensitivity to the ingredients. It has not been tested in people with herpes viral infections of the eye. The most common side effect is a burning sensation. Other side effects may be eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision [Source]
 
How does Restasis work?
Cyclosporine does at least two important things.  It changes how T cells interact with IL-2, reducing its effectiviness.  IL-2, or interleukin-2, is a messenger protein that tells your T-cells to replicate.  Because T-cells play a key role in immune reactions, suppressing their growth can reduce the inflammation in your eye. [Source]
 
Note: More on T cells here: http://en.wikipedia.org/wiki/T_cell

How many people use Restasis?

Allergan's Restasis earned $620 million in 2010. [Source]. Assuming an average user spent $300 per year, this yields 2 million users.

After months of initially hopeful results with honey and aloe vera, and a few other things I tried, I've reached a dead end. The problem went down from a distress level of 8 or 9 out of 10 to 1 or 2, but has returned to 4 or 5 which is not miserable, but quite bad.

I'll go to India next year, and in advance I'm starting to explore Restasis which, if things don't get resolved in the next few months, I'm going to have to perhaps try. So this is a research blog post. Please help by pointing out whether restasis worked for you, and what were your symptoms before you tried it.

The cure for eye strain/ dry eyes (for most cases of dry eye)

Prices in USA

http://www.frugalpharmacies.com/wiki/prices/Restasis/

Availability in Australia

There is a doctor who is able to supply this (in NSW).

Restasis is hard to get in Australia. Dr Chan has faxed the restasis prescription to a compounding pharmacy in NSW who I am eagerly awaiting a call from. The pharmacy will send me the restasis via post. The cost of the restasis is going to be about $60 a month. [Source]

You can perhaps get its DOG version. 

http://www.petanim.com/17504/msutton/dog-tear-production-cyclosporine-helps-conditions/

Under what conditions can Restasis work?

If you are making enough of all three liquids and the dry eye is due to inflammation, Restasis may work quite well. If you do not have inflammation but are simply not producing enough liquids, Restasis is not going to do much of anything. [Source]

Patients with an eye infection, as well as those with a history of herpes viral infection of the eye should not use this drug. 

Does Restasis work?

Restasis doesn't work.

New Study Shows Restasis Offers no Dry-Eye Relief following LASIK  (perhaps because goblet cells are damaged through LASIK and restatis works on the mebomian glands)

Goblet Cell Numbers and Epithelial Proliferation in the Conjunctiva of Patients With Dry Eye Syndrome Treated With Cyclosporine Kathleen S. Kunert; Ann S. Tisdale; Ilene K. Gipson [PDF]:  "Treatment of dry eye syndrome for 6 months with topical CsA resulted in an increase in goblet cell numbers in patients with NSS-KCS and SS-KCS and a decrease in epithelial turnover in those with NSSKCS. Reducing ocular surface inflammation might have an effect on the proliferative activity of the epithelium."

Effects of sequential artificial tear and cyclosporine emulsion therapy on conjunctival goblet cell density and transforming growth factor-beta2 production. by Pflugfelder SC, De Paiva CS, Villarreal AL, Stern ME.Cornea. 2008 Jan;27(1):64-9.

Cyclosporine emulsion, but not artificial tears, increases goblet cell density and production of the immunoregulatory factor TGF-beta2 in the bulbar conjunctiva in patients with dry eye.

PATIENTS WHO HAVE TRIED IT SAY THIS:

140 user reviews here.

" I went to my eye doctor (I live a couple hours away from my mom) and asked him for advice. He told me that Restasis only works in SOME people (he gave me a percentage but I don't remember it exactly now; some thing like 60%, or less, I think). " [Source]

"I have been using them for two years now and they really work for me. I have allergies to pollen, dust and mold as well as sinus problems and dry and itchy eyes were an annoying symptom. I had tried every over-the-counter eye drop in the drug store to no avail (my eyes were burning and itchy within 10 minutes). Now, I use Restasis twice a day and my eyes feel lubricated and don't burn at all. BTW, I use one application per day. [Source]

"As for how it works for me, I get immediate relief and use one vile for two to three days , then i can go for months without needing" [Source]

"Restatis didn't do much for me" (Source). 

"I've gone through 3 trays of Restasis (each tray being 30-days worth, but I use one vial twice a day) and it isnt doing anything for my dryness or redness. Lubricant eye drops have literally no effect on me. " [Source]

"I just wanted to report to you that I have been on RESTASIS for almost seven months…and I am symptom free. I am able to read again, use the computer…I don't even have to use any other drops! " [Source]

"I have been on it for 5 months now and I am not sure if it is doing much for me but I am willing to give it a few more months yet." [Source]

"I think I am a bit over my 6 month period and I just give up on it" [Source]

"trevor how long before restasis worked for you? I am almost 4 months no relief at al" [Source]

"I took Restasis for 7 months that time and did not notice any difference and a rise in my co-pay made my decision for me. I think about one-third to one-half of the people using Restasis are helped. This is my personal observation after reading patient's responses over a period of years." [Source]

I was on Lotemax for a while. I thought it was great as it turned my eyes as white as can be. But this steroid increased my eye pressure a lot, so my doctor took me off and I did the taper thing. Then I was allowed to use the steroid if I had a really bad flare up. Now I use FML ointment at night and it does not even come close to comparing to Lotemax, but I don't have the increase in eye pressure either. I have increased my restasis from 2 x daily to 4 x daily and that seems to help. Sometimes my eyes even feel moist. [Source]

OTHER PATIENT COMMENTS

 

For about three years, I've been suffering from dry eye and meibomitis (dysfunctional oil glands near the eyelashes). I've had an absolutely miserable time of it. But Restasis has been a huge help. 

Here's a bit of pre-Restasis background: For the dry eye, I had punctum plugs inserted in both lower ducts and I used preservative-free drops every hour or so. For the meibomitis, I was given doxycycline (100 mg/day) and I hot-packed my lids several times a day. Even with this treatment combination, I was still suffering from dry eye and visibly inflamed oil glands (they looked like tiny white bumps above the lash line). I also had some general eyelid inflammation due to all of the irritation that both of these conditions cause.

I started on Restasis about 2 months ago, and I am thrilled with the results. The eyelid and oil-gland inflammation has already been noticeably reduced, and my tear production feels much more normal. Every week, my eyes get better. That said, it took several weeks before I noticed _any_ difference. The drops have a gradual effect–I've read that it can take anywhere from 3 to 6 months for the full effect to be felt–so it requires patience and commitment. 

I have to use the Restasis drops every morning and night, and they're expensive, but they're very, very worthwhile. The only negative side-effect that I've experienced is a burning sensation when I instill the drops. That sensation goes away after several minutes. Right now, my insurance covers 80 percent of the cost (a 30-day supply is $100), but I would willingly pay the full price for the amount of relief the drops have given me. [Source]

BACKGROUND

Restasis is cyclosporine, a drug approved in the US in 1983 for suppressing  the action of T-cells and preventing transplant rejection. In the eye, it is said to improve tear production by decreasing inflammation 

in the lacrimal glands. It should be noted that other agents like Acular and oral flax seed oil are known to have similar action.

Restasis Side Effects

Restasis, a brand name for cyclosporine, is a prescribed immunosuppressant. Restasis is used to treat chronic dry eye caused by inflammation. It is applied using eye drops.[1] Other forms of cyclosporine are used to prevent transplant rejection, rheumatic arthritis and psoriasis.[2] Side effects of Restasis include redness, discharge and a burning sensation of the eyes. Wearing contact lenses may diminish the effectiveness of Restasis.[1]
 
Common Restasis Side EffectsRestasis Allergic Reactions
Those allergic to Restasis' active ingredient, cyclosporine, may have an allergic reaction when taking the drug. Inactive ingredients found in Restasis, including glycerin, castor oil, polysorbate 80, carbomer copolymer type A and sodium hydroxide, may cause an allergic reaction in those susceptible.[4] Allergic reactions to Restasis include hives, itching, rash, difficulty breathing, tightness in the chest and swelling of the mouth, face, lips or tongue.[5]
 
Restasis Precautions and Warnings
  • Restasis is classified by the FDA as pregnancy category C. It is not known whether the drug will harm an unborn child. It is also unknown whether Restasis can past into breast milk and harm children being breastfed.[1]
  • Drugs such as amphotericin B (Amphotec, Fungizone), colchicine, fenofibrate (Antara, Lipophen, Tricor), melphalan (Alkeran), nonsteroidal anti-inflammatory drugs like diclofenac (Cataflam, Voltaren) and naproxen (Aleve, Naprosyn), ranitidine (Zantac) and tobramycin (Tobi) may interact with Restasis.[2]
  • Cyclosporine may cause an infection or cancer, particularly in those are using drugs that lower the immune system in conjunction with cyclosporine.[2]
Common side effects of Restasis include eye redness or discharge, headache, diarrhea, flushing, hair growth, breast enlargement in men, heartburn, gas, ear problems and muscle or joint pain.[2]
Serious side effects of cyclosporine include pale skin, jaundice, purple blotches on skin, changes in vision, seizures, loss of consciousness, difficulty controlling body movements and swelling of extremities.[2]
 
Addendum
 
The Effect of Decreasing the Dosage of Cyclosporine A 0.05% on Dry Eye Disease After 1 Year of Twice-Daily Therapy
Su, Michael Y MD; Perry, Henry D MD; Barsam, Allon MA, MRCOphth; Perry, Alicia R BS; Donnenfeld, Eric D MD; Wittpenn, John R MD; D'Aversa, Gerard MD (Cornea: October 2011 – Volume 30 – Issue 10 – pp 1098-1104)
 
[Source]: Patients being treated with twice-daily topical cyclosporine for dry eye disease may find similar results by cutting the dosage in half after 1 year of treatment, a study found.
 
The prospective, randomized, single-masked, parallel-group comparison followed 100 patients who used Restasis (topical cyclosporine 0.05%, Allergan) twice a day for more than 1 year. Fifty participants continued with a twice-daily dosage, while the other 50 decreased the dosage to once per day.
 
Dry eye variables were measured at baseline and at 3 and 6 months.
 
At the end of the study period, tear break-up time improved from 3.11 seconds at baseline to 4.13 seconds (P = .0003) for the reduced dosage group. Lissamine green staining score improved from 6.51 at baseline to 4.42 at the study's conclusion (P = .024) for the reduced dosage group.
 
Seven patients in the reduced dosage group had to resume twice-daily doses during the study because of worsening dry eye symptoms.
 
"Our findings demonstrate that the majority of patients with dry eye already controlled with [topical cyclosporine] twice daily for at least 1 year can maintain suppression of disease and even show continued improvement after decreasing to [topical cyclosporine] once daily," the study authors said.

 
Abstract
 
Purpose: To evaluate the effect of decreasing topical cyclosporine 0.05% (tCSA) (Restasis; Allergan, Irvine, CA) from twice-daily dosing to once-daily dosing in patients who have already completed 12 months of twice-daily therapy for dry eye disease.
 
Design: Prospective, randomized, single-masked, parallel group comparison.
 
Participants: One hundred patients who had already been treated with tCSA twice daily for more than 1 year were randomized either to continue tCSA twice daily (n = 50) or to decrease tCSA once daily (n = 50).
 
Methods: Clinical measurement of dry eye variables was performed for all patients at baseline, 3 months, and 6 months. Mean data were used for within-group (longitudinal analysis) and between-group comparisons (once daily vs. twice daily).
 
Main Outcome Measures: Fluorescein tear break-up time, corneal fluorescein staining score, lissamine green staining score, Schirmer tear test, and ocular surface disease index.
 
Results: At the end of the study, patients whose treatment dose was decreased to once daily demonstrated statistically significant improvement in tear break-up time [4.13 seconds (n = 37) vs. 3.11 seconds at baseline (n = 50); P = 0.0003] and lissamine green staining score [4.42 (n = 37) vs. 6.51 at baseline (n = 50); P = 0.024]; fluorescein staining score, Schirmer test results, and ocular surface disease index did not change significantly (P > 0.05). Furthermore, the once-daily group demonstrated significantly superior ocular surface disease index compared with the twice daily group [15.91 (n = 37) vs. 22.62 (n = 48); P = 0.0496]. The remaining outcome measures between once daily and twice daily were not significantly different (P > 0.05). Seven of 50 patients (14%) in the once-daily group (vs. 0% in the twice-daily group) ended the study early because of worsening dry eye symptoms (P < 0.05) and went back to twice-daily dosing. [Source]
 
Conclusions: For patients with dry eye that has been controlled with tCSA twice daily for at least 1 year, decreasing to tCSA once daily may still allow suppression of the dry eye disease.
 
Korean study
Cyclosporine 0.05% ophthalmic emulsion for dry eye in Korea: a prospective, multicenter, open-label, surveillance study; Byun YS, Rho CR, Cho K, Choi JA, Na KS, Joo CK; Korean Journal of Ophthalmology (KJO) 25 (6), 369-74 (Dec 2011)

PURPOSE To assess the effectiveness and tolerability of cyclosporine ophthalmic emulsion (CsA) 0.05% in patients with moderate to severe dry eye disease in Korea. METHODSThis was a prospective, multicenter, open-label, surveillance study of 392 Korean patients with moderate to severe dry eye disease who were treated with CsA 0.05% for three months. An assessment of effectiveness was performed at baseline, and after 1, 2, and 3 months. The primary effectiveness outcomes were changes in ocular symptoms and Schirmer score. The secondary effectiveness outcomes were a change in conjunctival staining, use of artificial tears, global evaluation of treatment, and patient satisfaction. The primary safety outcome was the incidence and nature of adverse events. RESULTSA total of 362 patients completed the study. After three months, all ocular symptom scores were significantly reduced compared to the baseline values, while the Schirmer scores were significantly increased relative to baseline (p<0.0001). After three months, there were significant reductions from baseline in conjunctival staining (p<0.01) and use of artificial tears (p<0.0001). According to clinicians' global evaluations, most patients (>50%) experienced at least a 25% to 50% improvement in symptoms from baseline at each follow-up visit. The majority of patients (72.0%) were satisfied with the treatment results, and 57.2% reported having no or mild symptoms after treatment. The most common adverse events were ocular pain (11.0%). CONCLUSIONSOur findings indicate that CsA 0.05% is an effective and tolerable treatment for dry eye disease in Korean clinical practice.