Thread on dipyridamole drops under review

[Rebecca Petris]

Hi all,

Phew, so underwater lately it feels like I haven't been on the board in ages! Missing you guys!

I have a confession to make: I have been deliberately avoiding reading the thread on the above named drops all this time... just one too many things to try to learn about However, I am hearing concerns raised by both members here and members of the medical community about some of the things being said, and I've decided I'd better get off my rear at last and look at it. (Speaking of, my sincere apologies to the member(s) who PM'd me long ago. This is NOT the type of thing that deserved to fall into my procrastination bucket and I'm really sorry.) Because of the nature of concerns I have temporarily moderated the thread. It has NOT been deleted so please don't worry. I just need some time to get my brain around it and the concerns raised in order to figure out how best to handle.

Many thanks for your patience and understanding!!!

Rebecca

[Guest]

Hi Rebecca,

Thank you for explaining the situation. I've been posting quite a bit on this thread and am therefore slightly concerned that there has been some issues raised by the medical community as myself - among others - have been using these drops. I know there is no reason for alarm as yet and hope we will be informed if there is reason to be wary.

I'm in contact with the company MedInSight behind these drops and if you wish to speak to them please let me know. I am also available to speak to should you need to!

[Rebecca Petris]

Thanks Claire

[André Pereira]

Rebecca

My eye drops arrived today. You read something bad about them?

Should I stop using them?

[lizlou29]

I'm glad this has been flagged up. I hope that those using these drops have told there eye docs before they started. I understand the desperation to find something that helps with our eye issues but I worry that people are spending a lot of money on these drops and no one really knows if there are any risks associated with them. It's tricky because how do we find something that helps our condition if no one is willing to try it but I for one wouldn't want to be a guinea pig for this. We have to make our own choices i guess.

[cathy8889]

Hello,

I'm not sure if the answers to questions put forward to the producers of the drops by dry eye zone members were ever posted on here but here they are:

Hi Steve and Claire, and rest of the group members, here are Moshe's response to the questions asked.

Q1: Are the clinical trials still ongoing for these drops? If so, can you only participate if you're based in the US? (many of us are from the UK, Northern Ireland and Spain).

Trials have not yet started. Although we have been contacted by several universities seeking to perform such trials, they still require research funding to cover the costs of recruitment, data collection, analysis, ethical review board applications, regulatory permission etc. Usually such trials are sponsored by the company developing the product being tested. Since no company has yet licensed this invention, it is unlikely that any formal trials will be launched soon.

Nevertheless, there is a ray of hope. Since the compound being used, dipyridamole, is well known and has been approved for the past 50 years, doctors may freely prescribe it and compounding pharmacies may prepare it. We are aware that some doctors in the US are doing so, but we don’t have specific details concerning outcome.

Q2. From the patent we can see it has been tested on a lady with a pterygium, has there been any trials with a pinguecula? If so, to what result?

Pinguecula and pterygium are closely related. Pterygium usually starts with a pinguecula which progresses. We are aware that other patients are using it for these purposes but we don’t have a data collection team in place to collect and curate this information. We have been primarily focused with its use for dry eye.

Q3. What is the level of knowledge of these drops among ophthalmologists? Are they hopeful? Have you received support?

We have received many inquiries and requests for sponsorship of trials. Ophthalmologists, especially surgeons, are very keen to avoid surgery. Sadly, all research nowadays is either commercially driven or sponsored by donors. When one of those options materializes, we are sure there will be plenty of doctors willing to join in running trials.

Q4. How effective are these drops with people who suffer from underlying medical conditions like blepharitis or MGD?

We don’t yet know. It has been used with patients suffering from several anterior segment eye disorders with excellent symptomatic results. These uses have included dry eye but we don’t know whether it is meibomian gland dysfunction related or of other causes.

Q5. Do the drops work as a vasoconstrictor? If so, is there the risk of rebound redness? Are there any known side effects?

No, dipyridamole is in fact known to be a vasodilator. However we don’t know if at the minute dose we are using, it acts as a vasodilator or not. No studies have been previously done at this dosage level. We are using it at a dose 25,000 fold lower than the oral dose. This is a far greater safety of margin than other eye drops such as Vigamox or Restasis, which are either 1/400th to 1/800th of the oral dose. Considering that dipyridamole itself is a very safe compound, it is not surprising that we have not encountered side effects other than some stinging upon application to the eye.

Q6. Are there any benefits apart from the cosmetic enhancement of the eye?

Yes, we have seen very significant reduction in the pterygium tissue itself. Dry eye symptoms as well as hyperemia have resolved too.

Q7. When is it likely the drops will be released on the market? Is there a waiting list for those interested? (If so, how do we get on the list?) Will it be available to those outside the US?

To take such a product through the regular drug approval pathway generally costs around $13 million dollars, and takes 2- 4 years (since it is a new use for an approved drug--compared to $3 Billion and 14 years for a new drug). However, since the dosage of active ingredient is quite small, we have found out that in several countries it will qualify as a homeopathic dosage concentration, thus easing the regulatory pathway. In those countries where it can be recognized as a homeopathic formulation, it could be made immediately available. In order to facilitate this, it is necessary to first determine optimal formulation that can provide stability at room temperature. We have been working on this issue for quite a while, supported by a donation to cover formulation work and analytical testing. We believe we now have a formulation that is reasonably stable, but we are looking for further financial support to carry out longer-term stability studies and improved formulation development. As soon as a manufacturer or compounding pharmacy is found and licensed to manufacture the drops, we will let everyone on our mailing list know.

Q8. Will the preservative free version be available at the same time?

It is precisely our effort to avoid preservatives that has led to a longer development effort.

Q9. On the dry eye forum (which we are all on) some members have used compounding pharmacies to formulate their own homemade versions of the dipyridamole drops. Is this risky? Are we better waiting?

We cannot advise concerning this. The main concern would be safety and sterility. Obviously if people are experienced in pharmaceutical preparation and know how to take all safety measures, this may be low risk. We would advise that compounding pharmacies should ideally be involved in preparing these drops as sterility is essential.

Q10 If some of us were keen to donate towards your funding of this research how would we do this?

We are would be delighted to accept donations which could help facilitate further research. We have the ability to accept tax-deductible donations in the UK and the USA.

Q11. Is there a way we can be informed when the drops are ready to purchase?

Yes, as the emails that have been sent out to each of you have imparted, we will let you know when and where they are available for purchase.

Q12. How do these drops work on diminishing red veins/pings and pterygium (is there a simple science behind it?)

We don’t know all the answers to this question. It requires a lot of further research. However this drug possesses many therapeutic elements; it is an anti-oxidant, anti-inflammatory, anti-proliferative, anti-angiogenic, anti-neoplasmic, and anti-viral, among other known features it possesses (this is a link to our full text article: http://www.karger.com/Article/FullText/362113).

Thank you all for your encouragement and support during this interesting process. We wish everyone relief from these ailments quickly and safely. We will be in communication after the next important milestone is achieved.

We hope this helps.
Shira

[André Pereira]

My momentary despair is gone.
Thanks for reminding me that I'm a Guinea pig.

I'll post what i feel with the drops if the topic is unlocked.

[Guest]

Haha I didn't take too kindly to the guinea pig comment either!

I think, to cap this, that although there is much speculation about these drops it can be as damaging to say they are dangerous as it is to say it is a miracle cure. I can only go from my experience and my confidence in the company to say that, for me, there's been nothing negative to report and I feel they are helping me. I have been using the drops for three months. If anything changes I will report back here ASAP.

Like anything, experiences vary and you should take precautionary steps when trying anything new e.g - inform your GP, get a second opinion from your opthmologist, research the company behind it and prepare a list of questions to ask them, covering all your concerns. This is what I did.

I know we can't continue to discuss this while this thread is under review. If anyone feels uneasy I know MedInSight welcomes questions. Contact Shira for more info: shira@medinsight.org. Until then, and until we have solid facts, - or testimonies from medical experts or the actual consumers of this product - let's not speculate or put anyone at unease.

[lizlou29]

Sorry, didn't mean to offend you! Maybe my wording was rubbish or it means something different here. From the answers given to the questions above there are still a huge amount of unknowns and no proper trial is being conducted it seems. Just showing a bit of concern. Hope MedInSight continue the research because more effective treatments is what we all hope for! I'm merely voicing my opinion as I understand why the thread needs to be reviewed and why there is genuine concern from medical community.

[littlemermaid]

Yep. There's NO WAY I would use experimental meds off the internet without having an eye doc supervise what it's doing. With docs, I've used off-label meds on my own child, although they've been through trials on adults somewhere in the world. We are currently looking at BioMed Sci research for junior and although it is VERY exciting, research scientists don't like to deal with the consequences.

[André Pereira]

Do not worry Lizlou I'm just playing with my condition.

I've read everything I could about this medicine. And as you said, I made my decision.

When I saw the locked topic, I was worried, although I have taken the risk, I get worried.

You who are in a first world country may be able to count on fantastic doctors who have come with it. Here I takes me three months to be served by a competent physician. And even helping me a lot, he never prescribe me the things I have done to improve my condition.

That is, I'm on my own.

[littlemermaid]

Very sorry for my unhelpful post. We live in hope. If anyone knows a fantastic first-world doctor without a long wait, please say... Signing up for clinical trials for new eyedrops may provide what we need, especially if we can persuade them to be multicentre in different countries, which makes sense if they want to market them globally. Looks like most new dry eye drops work on the immune response like this one http://ois.net/elevens-celniker-talk...ry-eye-trials/. It would be a odd if that process isn't studied and there are also cell changes.

[André Pereira]

Littlemermaid,

Your post is not useless. I apologize for not expressing myself right. I leave my emotions on my fingertips in some time. I get angry when I think of all queries where the doctor does not raise his head to look at you. And all those things we all already live.

I know we are all in the same boat.

Each of us has a different profile. I think you can not trust my problem only to a "traditional doctor". So I venture in unconventional treatments.

I consult with a homeopathic physician, he follows an alternative line.

I showed the drops and said the substance has vasodilator effect, but is in homeopathic doses. He told me that every substance in homeopathic dose has the opposite effect. Amazing, I thought.

I love reading double-blind trials, but do not base on just research. I do not think the solution to our problems will be found in one tool but a set of them.

For example: I do not eat anything processed or industrialized. This helped me a lot. I did not realize how much my eyes were affected by food.
Last week I ate a delicacy in the house of a friend, I think it had industrialized chocolate margarine and stuff. My eyes went bad all week. (One of) My doctor looked at me and then said, what you ate wrong?

Finally. I'm having a good experience with eye drops.
I have already put so much worse substances my eyes coming from large companies.
Why not try this?

And thanks for the useful information that you give.
And again I apologize. No complaints is aimed at you!

[nubirth]

now, i dont know whether to order the drops or not...............

[Rebecca Petris]

Sorry guys that I haven't followed up sooner. Mom recovering from pneumonia, complications during our lambing season and a gajillion other things making it too easy to let things fall right back off my 'urgent' radar. I see how deep the interest is in this and promise I will get to it asap.