Allergan Androgen Eye Treatment

[mylittlem]

I have found some information that Allergan is in the clinical trials phase for its androgen-based eye treatment. I believe it is actually a skin cream or ointment rather than an eye drop. I have searched their web site and cannot locate an estimated timeframe of when they will move forward with this product. Does anyone have any further information on this? Additionally, I have read that Argentis is close to the clinical phase for 3 of their hormone products for the treament of the eyes. Any information that anyone has come across on this?

[ringo]

I must say that I have read about at least 7-8 breakthrough medications for dry eye in the pipeline in successful phase 2 and phase 3 clinical trials (starting from 2003 onwards), and including- pimecrolimus, tacrolimus, ecabet sodium, diquafosol, androgen, and others, which just never saw the light. I have no idea why-- sometimes i suspect it is because they cured dry eye altogether, or made artificial tears use obsolete
Anyone have any information what happened to all these pipeline treatments??

[Gretchen]

Rebecca has posted a lot of pipeline information here:

http://www.dryeyedigest.blogspot.com/

As for why these therapies never make it to phase II or III is that many drugs never make it to phase II or III. You are just not paying attention to those : )

And dry eye is difficult to treat. Opthalmics in general are difficult to prove efficacy. One reason is that the current mode of opthalmic drug delivery is in drop form which is incredibly inefficient. Not great news for us.

[Rebecca Petris]

I also keep a dry eye clinical trial roster at this link. It's probably several months out of date at the moment except for some brief updates last week but every now and then I go and clean it up.

I have not heard any updates on Allergan's androgen in quite a long time. I thought that after Allergan took it over from Sullivan's team it pretty much came to a standstill.

The Argentis drugs, according to their website, are >4 years from market. However, one thing to keep in mind with these new therapies is that often it is possible through compounding to procure drugs which are past the basic safety testing but have a long ways to go to FDA approval. Many on this board have used hormone-based treatments (whether drops or creams) as well as doxycycline drops that way. Also keep in mind the option of participating in a clinical trial.

[ringo]

Thank you for your replies, the links are very interesting.

However, I still can't help feeling so discouraged by how slow the processes of FDA approval are, or by how very promising drugs are halted at a standstill, despite showing good efficacy and safety.

Is there any way to inquire about what is happening to a certain drug that has been tested inclinical trials with successful results and then noone hears any developments?

[Rebecca Petris]

Is there any way to inquire about what is happening to a certain drug that has been tested inclinical trials with successful results and then noone hears any developments?

Yes. Ask the company sponsoring it (or if possible doctors participating in trials), and read the press releases. Sometimes the information is buried deep in company financial statements & quarterly reports.

If a drug dies in Phase III, there is always news about it at some stage because investors have a right to know. But there can be long gaps. Judging purely by time elapsed since last news, you might assume Rebamipide was a goner but it's not. I think the first Phase IIIs were messed up and they had to start over with a new partner last year.

If it dies in Phase II, there may or may not be a press release or it may be mentioned in financial reports. In those situations it's either safety or efficacy or both - but bear in mind efficacy can mean any number of things. It may work on a lot of people but not predictably enough, or it may work on too small a sub-population of dry eye to be economically viable. Sometimes there is just no more news and in that case the implication is pretty obvious. Personally I don't consider myself smart enough to double-guess the scientists' evaluation of the results... and much as I may succumb to the temptation to frequently gripe about pharmaceuticals still I know they are very highly motivated to get another dry eye drug on the market.

So in brief, either hunt for the news (it IS there) or subscribe to my newsletter

This thread was started by mylittlem specifically about the current hormone-based treatments. If anyone has further information please let us know.

[ringo]

Thank you so much Rebecca,

Your reply was very informative and i subscribed to your newsletter

I will try to inquire about the androgen treatment and post about it if i have any success with finding information.

Thank you again for your time, effort and consideration.