Re: Long-term prophylactic use of Squalamine:
>> What do you think of the following idea... Levitt and GENR are positioning Squalamine to be a monthly or bi-monthly nasal spray/pill that would be taken by all people starting at some age (say 30 and over) that will prevent future Wet AMD. If the 10mg has no long-term side effects, all people could take this monthly dosage and thus approx. no one would ever have to face Wet AMD. This market would seem to be massive relative to the current AMD market. <<
tennisman: A few points to consider:
1. An indication from the FDA for long-term Squalamine use would require long-term safety and efficacy data!
2. Reimbursement by Medicare (or private insurers) for long-term prophylactic use in healthy individual is highly unlikely, IMHO. (Please see the comments below about Retaane.)
3. Squalamine does not have good oral bioavailability, so a pill formulation is probably not practical. A nasal formulation might be possible, but it has not been investigated by GENR or anyone else.
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In my opinion, the best bet for a long-term drug indication in AMD is not as a prophylactic for individuals with healthy eyes, but rather as a means of preventing or retarding the progression of dry AMD to wet AMD. This is the indication that Alcon hopes eventually to garner with Retaane. Phase-3 Retaane trials are now enrolling patients with dry AMD, and final data will be available in about six years. Regards, Dew
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