To the editor:
I am writing in response to the June 25, 2018, commentary regarding the evolution of care models for diabetic macular edema. I think the conclusions reached in the paper do not accurately reflect physician experience with Iluvien implants in the United States. When addressing the place of steroids in DME, Dr. Lindstrom states: “The double-edged sword of steroids is especially seen ... with Iluvien implants, in which steroid-induced glaucoma is a common occurrence.”
Alimera has two clinical studies capturing real-world Iluvien data. These are the prospective PALADIN and retrospective USER studies. These real-world data sets show no significant increases in IOP-lowering surgeries or IOP elevations after Iluvien treatment compared to before Iluvien treatment. On the therapeutic side, these studies demonstrate significant reduction in treatment frequency among those patients treated with Iluvien. Between 53% and 67% of patients did not require further DME treatment. This dramatic reduction in treatment burden has been positively received by patients of the many clinicians who have incorporated Iluvien implants into their treatment regimen for DME.
In deciding the role of the Iluvien implant in the treatment of DME, it is important to consider recent prospective and retrospective study results and how they have demonstrated that the FDA guidelines have effectively mitigated the glaucoma risk and how the Iluvien implant has dramatically and significantly reduced the treatment burden on patients with DME.
Thank you for the opportunity to comment on this important topic and offer another perspective about Iluvien implants for DME.
Alexander M. Eaton, MD
Fort Myers, Florida
Disclosure: Eaton reports he is on the speakers bureau of, receives grant/research support from and is a stock shareholder of Alimera Sciences.
- Singer M. Treatment burden associated with intravitreal injections in the real world: PALADIN phase 4 trial with fluocinolone acetonide 0.2 µg/day. Presented at Association for Research in Vision and Ophthalmology meeting; April 2018; Honolulu.
Dr. Lindstrom responds:
While surgical intervention for medically uncontrollable glaucoma after Iluvien implants may be rare, elevated IOP is not. Quoting directly from the Alimera Iluvien website under important safety information: “Iluvien should not be used if you have glaucoma. ... The most common side effects reported in patients with diabetic macular edema who were treated with Iluvien include cataracts (Iluvien 82%; sham 50%) and increased eye pressure (Iluvien 34%; sham 10%).” I remain supportive of careful monitoring of IOP in patients with Iluvien implants and appropriate treatment as indicated.