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Re: DFRAI post# 188019

Monday, 03/02/2015 12:59:47 PM

Monday, March 02, 2015 12:59:47 PM

Post# of 252302
Squalamine didn't reduce the number of lucentis injections, but it increased visual accuity.

People do not realize that Ophthotech excludes occult patients from their trials. Opht only includes classic patients in their trials.

When you look at classic only patients squalamine outperformed fovista. We shall see if that is still the case later this month when the rest of the squalamine data is released


from page 82 of Ophthotech s1

The term “pure classic” applies if 100% of the patient’s abnormal new blood vessels are well defined or located above the RPE. The terms “predominantly classic” and “minimally classic” are sometimes used to indicate some classic component of the disease, such as when only a portion of the patient’s abnormal new blood vessels are well defined or located above the RPE. The term “pure occult” applies if none of the patient’s abnormal new blood vessels are well defined or located above the RPE. Based on enrollment of untreated wet AMD patients in third-party clinical trials, the pure occult subtype accounts for approximately 40% of the cases of subfoveal wet AMD in the wet AMD patient population. Some occult choroidal neovascularization is present in predominantly classic and minimally classic choroidal neovascularization. For example, in minimally classic choroidal neovascularization up to 99% of the blood vessels may be characterized as occult, thus only 1% different from 100% or pure occult.

Ohr's data includes occult and diabetic patients

from page 88 of the Ophthotech s1

We made no meaningful changes to the inclusion and exclusion criteria in our Phase 2b clinical trial from those we used in our Phase 1 clinical trial. As in our Phase 1 clinical trial, We believed that data regard we did not enroll patients with pure occult choroidal neovascularization because it would be difficult to adequately observe and measure the changes in the choroidal neovascular morphology using routine imaging techniques in patients without any classic component to their choroidal neovascularization.ing neovascular regression would be useful in assessing the effects of Fovista in combination with Lucentis and in supporting the proposed mechanism of action for Fovista.

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