A closer inspection of the 40mg data from the “207” study:
>>can anyone expand on this comment from the Hambrecht report: "two patients in 40 mg non-study eye had changes of +5.6 lines" Did they only pick one eye to study? <<
It is standard procedure in ophthalmic trials to pick only one eye from each patient for inclusion in the formal data set (the “study” eye). This reduces patient-specific bias by assuring that each patient is weighted equally in the statistical calculations regardless of whether the patient has one diseased eye or two.
I’m pretty sure Jason Kantar is wrong when he says that two non-study eyes had a gain of 5.6 lines (28 letters) relative to baseline. As far as I can tell, only one patient had such an improvement in the non-study eye. If there had really been two non-study eyes with a gain of that magnitude, the average change from baseline for the six non-study eyes would surely have been greater than 0.5 lines, which is the amount reported in slide #13 from GENR's "Corporate Overview" slides.
To see the 40mg clinical results from the “207” study for both the study eyes and the non-study eyes, you have to combine the data from slides #13 and #14. In the overall set of 12 eyes (six study eyes and six non-study eyes), only two eyes (2/12=16.7%) had an improvement of 3+ lines relative baseline at two months (one month from the end of treatment). This is well below the 33% of eyes (13/39) which had improvement of 3+ lines in the Mexican study at the same time point.
Further, in the 40mg cohort of the “207” study, the average gain relative to baseline for all 12 eyes was 0.8 lines (3.75 letters). This, too, was well below the average gain relative to baseline of 1.4 lines in the Mexican trial at the same time point.
Thus, on closer inspection of the 40mg data in the “207” study, I have to reverse my earlier comment that these data are consistent with the Mexican data. In fact, the 40mg data from the “207” study are clearly worse than the Mexican data, even when allowing for inclusion of the non-study eyes. Regards, Dew
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