New anti inflammatory topical medications

[peter56]

Hi all,
it seems, that it is not possible to find a compound pharmacy in the USA and Canada that will compound the new much more efficient topical drugs very soon.
In most EU countries every pharmacy is authorized to import for their patients drugs - medications from countries autside of the UE, even there is no official approval for that drug.
So it is no problem for example to import Restasis from the USA.

So my question, is it possible for US and candadian pharmacies importing drugs from a foreign courtry and such drugs have no FDA approval.
Even if one compound pharmacy will make the new drops-gels,
it will be impossible to supply all patients in need of these drugs.

So only a pharma company will be able to deliver auch high quantities.

The prevalence rates of the dry eye world wide are almost exploding and there are no anti inflammatory drugs available beside steroids.

In japan for example about 5% of the 18 years old high school students have first signs of DED and about 17% mild to moderate MGD.
In the USA and europe the prevalence is not as high, but also alarming.
Among people under 60 the number one cause is now the Computer-Vision-Syndrome - MGD,
number two contact lens induced MGD and later on DED and
number three LASIK - refractive surgeries.

The ophthalmologists are recommending computer work no longer than 4-5 hours. But who can that tell her-his boss?

According to the statistics in the USA there are 34-36 milion contact lens wearers now. Most of them do wear their CL very frequently.
Statistics saying that 30 to 35 of all CL wearers do develope MGD after 4-5 years of CL wearing.

About two years ago, I have seen US advs promoting CL for school children! If I remember right, if was: "if your child has a better vision it will be better in school".

So the scale of all these problems are increasing dramaticly and we have almost nothing to countering that.
All people here older than 40 - parents do know, that it is almost impossible to motivate young people to stay away from CL and LASIK.
When was 20-30 I also had not much cercerns on the future.

Peter

[Tankie]

What is the name of the new medication you are referring to?

[peter56]

Hi Tankie,
my question, is it possible for US and Canadian pharmacies to import from a foreign country prescription drugs, that have no FDA in the USA-Can.
For example if someone does go to his local pharmacy with a prescription for Azyter drops. Is this pharmacy authorized to order the Azyter drops in the UK or in France and importing them.

It may be possible ordering prescription drugs in europe, but if the US custom will intercept the package the patient will get problems.

So only official orders with a prescription should be possible and legal.

[spmcc]

Just FYI - In Canada and the US, we can get cyclosporine in any concentration compounded into any approved vehicle our doctor wants. But a prescription is required. Any compounding pharmacy can make them.

We can also get azithromycin eye drops (Azasite or compounded). They also must be prescribed by a doctor who can stipulate what concentration and what vehicle.

Additionally, in Canada, if a doctor has exhausted proven treatments and believes that his/her patient needs a prescription drug NOT available in Canada, but available anywhere else in the world, he/she can do the paperwork and get it for us. Again, a doctor's prescription is required.

I suppose there is always a chance that US or Canadian Customs will intercept and seize the package and flag names.

[peter56]

Hi SPMCC,
thank you for replying.

The compound pharmacy in germany does only deliver the new formulation CyA eye drops on prescriptions and only within germany and the two other german language countries austria and switzerland.
I had to wait for my last supply about 7 weeks.

The universal topical drug distribution system Novesorb has nothing to do with the CyA drops from germany.
Novasorb has been developed at the univ of Geneva-Switzerland and is now made by Novagali in france.
Please refer to the article of dr Lallemand - J Drug Deliv.

So if you do have available new formulations of CyA in canada, why it is not possible to import that stuff to the USA.
It seems that almost all US patients do take that expensive almost useless Restasis.
Restasis is not much more than artif tears. It is based on the old Refresh Endura castor oil drops - one package 17 USD - ten years ago. Then Allergan added 0.05% CyA to the castor oil in the Refresh-Endura and that is Restasis for I think 175 USD.
The efficacy of Restasis was rated at 10-15% and the control group - artif tears only at 5%. The CyA in Restasis doesn`t penetrate into the corneal stroma.
So it is impossible to get the inflammation out of the corneal nerves that ar controlling the tears reflex system.

[Hopeful2]

In what form do you think CyA should be taken? Would a compounded form of CyA work better? What should the carrier be? Is there another drug that can get the CyA to the stroma? Is inflammation of the stroma observable in any way?

Thanks.

[Rebecca Petris]

I have moved this to the Patients & Pros section so that anyone who needs to post here can do so.

Peter, I finally read your original post. I don't know the answer to the question of whether non FDA approved Rx drops can be imported by a pharmacy etc. I should think anything really good for dry eye would be made by Leiters in San Jose - IF they can do so without violating a patent but then so much of the latest stuff IS patent protected so they can't. - I see you're not a Restasis fan... I'm not either, for many reasons, but I do have to admit I know quite a few people that it HAS helped. More options = more people helped. Incidentally lots of places compound cyclosporine drops in various concentrations and vehicles in the US so I'm not sure I understand why there would be a need to import any?

I agree with your concerns about contact lens wear, MGD, and the trends to fit contacts on ever younger patients. And, of course, LASIK. - I do feel we are looking at quite a dry eye epidemic but I would fault not just contacts but diet and office environments. - Personally I do not feel that drugs hold all the answers to these problems though... They play a role, but looking collectively at the 'anecdotal' evidence on DEZ over the years the practical side of managing/treating dry eye symptoms plays at least as big of a role.

[Pinky]

Hi Peter56,
Thanks for the info. There is a drop that will be available soon in the US and Canada that uses Novasorb technology. For more info:

http://www.eyewiretoday.com/view.asp...ry_eye_therapy

According to the ocusoft website it is available now. Has anyone tried it?

http://www.ocusoft.com/retaine-mgd-o...-emulsion.html

[peter56]

Hi Pinky,
the Retain-MGD drops are lipid layer drops, like Soothe-XP and Systane Balance.
Retain-MGD is identical to Cationorm eye drops in europe, available there since
2008.
Patients in france told me, that Cationorm is not better or worser than these other lipid eye drops.
So only testing Retain will show their therpeutical effects.

[peter56]

Hi all,
I am afraid, that it will still take several months or even years,
until new and much better working CyA-TAC will become available in the USA.
Suppressing the ocular surface inflammations is the key to treat successfully the dry eye diseases!
The modern T-Cell inhibitors like CyA, Tacrolimus, Everolimus etc. are steroid sparing drugs that do have less adverse effects.

Is it possible for US patients to get the Modusik-A Oftena 0.1% CyA drops from Mexico?
Modusik-A drops are available in Mexico since 2005. The drops are not so efficent as the CyA drops from germany, but better than everything available in the USA, beside steroids!

There are online pharmacies in the USA, that are claiming to deliver Modusik-A without a prescription to the USA and Canada.
But I think getting a prescription will be better!

I have applied Modusik-A before we got the CyA from germany and I had not problems like severe burning.

Peter