ken
Great post and I really missed the forest for the trees
i.e. cataracts
I think this outlines the problem ... succinctly
Let's assume low dose works, at some % of cataracts, they won't pass the FDA. And at some lower %, they will have trouble competing I am guessing.
But this really is NOT to be ignored ....
At 12 months, IOP for low dose looks great but no data for cataracts. We all know when they leave something out, it ain't a good sign.
Again - thanks for your insight.
Dilemma Me:
(a) the trial works - but the cataracts issue (potentially)
grow(S) over time
a stock pump (a) in the immediate timeframe
(b) Alimera gets their 180 day expedited review
a ditto stock pump (b) of some type
(c) I would expect that the FDA would want a current
snapshot of the cataracts experience rate as near to
their review as possible .... and it could mean "curtains"
and no paycheck for psivida .....
or not ... depending on DATA
darn!
shootin from the hip this leads me to think if (a) happens
psdv will do an offering i.e. 2 million shares to get
cash thru the door ..... well before its FDA time ...
but its more 'stay alive cash' vs trial cash ...
FWIW
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What follows is cherry picking to the extent that it
came up quick in google .... but may NOT be applicable
in using as a comparison to IIuvien ...
=======================
cataracts
-- This MAY NOT be applicable to Ken's post
-- but this took several googles
=======================
Important findings
The percentages of phakic patients who underwent cataract surgery before 3 years were 13%, 23%, and 51% in the laser, 1-mg, and 4-mg groups, respectively. The cumulative probability of undergoing cataract surgery over 3 years was 31%, 46%, and 83%, respectively.
"It is valuable to know that both application of laser and IVTA are superior to no treatment of DME when the data from this study were compared with unpublished data from untreated patients in the ETDRS study," Dr. Ip said. In the ETDRS study, the median change in VA was –6 letters, compared with +4 letters in the laser group, +1 letter in the 1-mg group, and +2 letters in the 4-mg group.
modernmedicine.com
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Caution - what follows reads "positive" but if you take the
article as a whole ... (I think) less positive than what
I am posting ....
Future of Corticosteroids for DME
The DRCR results apply to monotherapy for DME, but it is likely that combinations of therapies will be the best options in the future, especially in refractory cases. Combination therapies may be important for minimizing repeated administration and the risk of side effects in chronic disorders such as DME—i.e., cataract or glaucoma in the case of steroids, laser-related field defects and scotoma in the case of laser treatment, and intravitreal injection in general. The Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME) study is a National Eye Institute-sponsored Phase III clinical trial of nearly 700 patients that began enrollment in 2007 and will directly compare laser alone with laser combined with triamcinolone, laser combined with ranibizumab, and ranibizumab alone. Similarly, as mentioned, Allergan is studying laser versus a combined dexamethasone implant and laser. It will be some time before quality studies answer whether corticosteroids hold promise as combination therapies, but the initial transient improvement in visual acuity and macular thickness reported in monotherapy provides hope for future applications involving this class of therapeutics.
revophth.com
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Cataract within IIuvien trial ....
The percentage of low dose patients that had an improvement in BCVA of 15 letters or greater from baseline decreased from 20 percent at the three-month readout to 10 percent because one patient developed a cataract and one patient developed an epiretinal membrane involving the macula prior to the readout. The development of cataracts and epiretinal membranes in a diabetic population are not unusual and are commonly addressed with surgical intervention.
drugs.com |
