Victor Gonzalez, MD, shares updates from the Phase 4 Paladin study regarding the safety and efficacy of fluocinolone in diabetic macular edema.
My name is Dr. Victor Gonzalez. I'm a vitreoretinal specialist at Valley Eye Institute in McAllen, Texas.
Today I'd like to discuss the results of the Paladin study. This is a Phase 4 study that was designed to evaluate the safety and efficacy of intravitreal fluocinolone in patients with diabetic macular edema and to look for the incidence of intraocular-related pressure events.
My presentation here at ASRS will focus on evaluating the outcome in patients with good visual acuity. Not surprisingly, you know, when we look at those patients, before the administration of the fluocinolone, the patients not only required multiple applications of intravitreal injections to try and control the edema. There was significant fluctuation in the retinal thickness as a result of that treatment. On average, these patients were being treated about 4 injections a year. And as we know that significantly undertreated. As a result of that, not surprisingly, many of these patients were losing vision. Post-fluocinolone application, the number of intravitreal injections that were required to maintain the patient stable, the majority of them required 2 or less.
Not only was there a reduction in treatment burden, but there was also an improvement in visual acuity. On average, those patients, if they had a visual acuity of less than 20/40, were gaining eight letters, post- the fluocinolone application, and those that had good visual acuity seem to be stabilized to maybe lose 2 letters, suggesting that there was probably a ceiling effect as a result of a better visual acuity.
When we looked at the anatomical outcomes, and those subjects with better than 20/40 vision and those with worse, there was no significant difference, there was a significant reduction in the central retinal thickness, regardless of visual acuity.
When one looked at that same group, to see if there was any difference in intraocular pressure events, what we found was that there was less intoracular events in the better acuity patients. Overall, less than 3% of them required incisional surgery, and 3 out of the 6 were treated because of neovascular glaucoma.
So to summarize, the fluocinolone implant has been very effective and safe. In the treatment of diabetic macular edema. It appears that good visual acuity seems to correlate with stabilization of vision and less complications from intraocular pressure with this drug, used on label.