Jay Prensky, MD, talks about the results of the PALADIN real-world study and the use of the fluocinolone acetonide 0.2 ug/day implant in DME patients.
Jay Prensky, MD, FACS: Well, we found that there was a significant reduction in treatment burden, over the first 6 months anyway, compared to what was historical for these patients. They were receiving injections from every 2 to 3 months. But overall, it showed that it was a safe and efficacious drug that may have some long-term benefit in terms of treatment burden.
Also, in spite of the average duration of diabetic macular edema prior to receiving the Iluvien implant, of a 5-year duration, there were still patients that were gainers, and I mean I thought that was pretty impressive considering these people had been treated for long, long periods of time prior to receiving the implant.
So basically, a third of patients that have received the fluocinolone implant, that had visual acuities of 20/40, went on to receive an average of 2 further injections in that 6 months. But, that left 67% of patients with 20/40 vision that had no further injections. The treatment burden appears to be significantly reduced and it appears to be safe and effective and, at visual acuities, there was a positive result with visual acuity improvement. Small with better visions - and this may be a ceiling effect - and a greater visual acuity improvement for those that had poorer vision to start.