I'm going to venture a prediction about the dry eye drug scene in the coming year.
I predict that in the US we will see a trend towards filing NDAs (new drug applications) with the FDA for eyedrops well off the beaten path of the new drug model where a small company comes up with something new and promising, gets some capital to put it through some testing, then gets bought by a pharma and proceeds through all the agony of Phase III clinical trials.
I think we'll see 2 to 5, possibly even more, NDAs of this less conventional type. The formulations will not be particularly sexy. They may be substances that are sold over-the-counter everywhere except the US due to the weird way the FDA regulates OTC eyedrops, or they may even be substances currently compliant (more or less) with the OTC regs that actually have considerable therapeutic potential and therefore deserve to be in a different category, though whether they merit the price consumers (or their insurers) will be feverishly (or reluctantly) doling out for them may remain a question. I also predict that one or more of these will be more effective than any other Rx dry eye drug, and that one or more of these will be nothing more than an artificial tear sold at an absurdly high price.
1 comment:
Hi, there! Been reading your blog and other Dryeyezone and Dryeyetalk info. Very interesting!
RE: 2008 forecast - have appt. next week, and would like to suggest a new drop (have tried ALL of them, I think, unfortunately, including doxy, Restatis, OTC, etc.). Cannot give up, though - do you have ideas? New and off-label great to me!
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