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From: luvb2b (Rep: 2098) reply to luvb2bDate: 03/26/2019 11:33
Forum: Aldeyra Therapeutics, Inc - Msg #37Thread #674072366 (Rec: 0)
i think the main problem is the trial was done vs. placebo. they probably have to go vs standard of care to get a really strong reaction.

Re: here's the link to the original allergan pr, they mention 25m patient populat...

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Reply to luvb2b - Msg #2779935 - 03/26/2019 10:45

here's the link to the original allergan pr, they mention 25m patient population for dry-eye.

there was another recent deal between bausch & lomb and mimetogen to option a drug in development. terms were not disclosed, but here again they were saying 2.5b annual market for dry-eye.

aldx trial results were not for dry-eye specifically, but there's some overlap between that and allergic conjunctivitis that the aldx trial was for.

the aldx presentation mentions they are the first successful p3 trial in some time, and they had a very high relief of symptom response (2+ points on the scale, which they claim is first seen in a while). another highlight they claim is a novel mechanism of action. there are several other studies they need to do to reach approval so it's not "the" final p3 trial. but certainly the speed at which they are able to enroll and complete trials and their cash balance says they should be funded adequately (offering completed on the last super-spike after phase 2b results.

some additional notes from the 10k
There are approximately 20 million dry eye disease patients in the United States, yet only two drugs are approved for dry eye disease treatment, cyclosporine (0.05% as Restasis® or 0.09% as Cequa®) and lifitegrast (5% as Xiidra®). The activity of both drugs has been observed to be minimal or lacking in the majority of patients, and weeks or months of treatment may be required to achieve even modest clinical benefit.

There are approximately 100 million patients in the United States with allergic conjunctivitis, and we estimate that up to 30 million of such allergic conjunctivitis patients do not respond adequately to, or are dissatisfied with, topical antihistamines, the current standard of care. A primary reason for dissatisfaction with antihistamines appears to be lack of durable activity, which may be due to the fact that histamine is only one of the biological mediators of the disease, and the fact that increased histamine levels persist for only 10 to 20 minutes following allergen exposure.

Many patients manifest symptoms of both dry eye disease and allergic conjunctivitis, and differential diagnosis can be challenging for physicians. Approximately half of dry eye patients complain of itching, which is generally considered the result of allergy, and approximately half of allergic conjunctivitis patients complain of dryness, which is generally considered the result of dry eye disease. There are currently no United States Food and Drug Administration (FDA)-approved products that are indicated to treat both dry eye disease and allergic conjunctivitis. Neither cyclosporine nor lifitegrast have been approved for use in patients with allergic conjunctivitis, and antihistamines are known to exacerbate ocular dryness. Thus, with the possible exception of topical corticosteroids (discussed below), we believe that no currently available drug for dry eye disease or allergic conjunctivitis is likely to be effective for the treatment of patients who experience symptoms of both diseases.

aldx has a bunch of other programs advancing on this rasp anti-inflammatory platform as well.

so netting 95m of cash on the balance sheet, no debt w/ 27.5m shares outstanding around $11, the valuation given here is $300m for the whole co, and $205m net of cash. it just seems far too low given past deals, the size of the market, and the upside of dry-eye and other product candidates.
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