PSivida Corp. (PSDV) provided additional efficacy and safety
data from its late-stage trial of its Iluvien opthamalic treatment
for diabetic macular edema, which can cause vision loss.
Shares, which initially climbed more than 10% premarket, were
recently up 2.4% at $3.36. The stock was at 65 cents a year
ago.
The latest data were presented at the Angiogenesis 2010 meeting
in Miami. PSivida had reported some results of the late-stage
trials in December. Then, it disclosed its drug to treat
diabetes-related eye disease was found to be effective in eagerly
awaited results of two late-stage trials.
The study included 956 patients who either received a high dose
of Iluvien, a low dose of Iluvien or a 'sham procedure.'
Among the new data, in a 24-month study, more than 50% of
patients receiving a low dose of Iluvien, which is inserted into
the eye, had more improved vision. More than 75% of the patients
received a single administration of the low-dose, with more than
one-third of them having improved vision.
Patients receiving the low dose also were less likely to require
further treatment. Nearly twice as many patients in a control group
required laser treatment compared to those receiving the low dose
of Iluvien.
The new data also showed that patients receiving the low dose
were slightly more likely to develop glaucoma than the control
group but had slightly lower rates of retinal detachment and
vitreous hemorrhage.
The company previously announced that it plans to file a new
drug application with the Food and Drug Administration for approval
of the lower dose in the second quarter.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
Tess.Stynes@dowjones.com