This article is part of MPR’s coverage of the American Academy of Ophthalmology 2019 Meeting, taking place in San Francisco, CA. Our staff will report on medical research related to eye disorders, conducted by experts in the field. Check back regularly for more news from AAO 2019.
SAN FRANCISCO – Dexamethasone intravitreal implant was found to be effective in patients with diabetic macular edema who were nonresponders to anti-vascular endothelial growth factor (VEGF) therapy, according to data presented at the 2019 American Academy of Ophthalmology Meeting in San Francisco, CA.
In the AUSSIEDEX study, 55 treatment-naïve patients and 145 anti-VEGF nonresponders were administered dexamethasone intravitreal implant at baseline and retreated at ≥16-week intervals as needed. The primary end point of the study was mean change from baseline in visual acuity/central retinal thickness; secondary outcome measures included the percentage of patients with visual acuity changes from baseline at 1 year, as well as safety.
Results showed that both patients who were switched from anti-VEGF therapy early (3 to 6 injections) and late (>6 injections) had significant mean changes from baseline in central retinal thickness (−64µm [P ≤ .019] and −60µm, respectively; [P ≤ .030]) at week 52. In addition, 50% of early-switch patients and 31% of late-switch patients had >5 letter gains, while 25% and 29% had >5 letter losses; respectively. Intraocular pressure lowering drugs were utilized by 17.9% of early-switch patients and 18.8% of late-switch patients. With regard to safety, there were no reports of serious adverse events; 2 patients did withdraw from the study due to intraocular pressure increase.
Based on their findings, the authors concluded that dexamethasone intravitreal implant “statistically significantly improved anatomic outcomes at all post-baseline visits up to 12 months in patients with [diabetic macular edema] who did not respond to prior anti-VEGF treatment (early and late switches).” They added that “better outcomes were observed in the early switch subgroup, compared with the late switch subgroup.”
Dexamethasone intravitreal implant is FDA-approved under the brand name Ozurdex for the treatment of diabetic macular edema, macular edema following branch retinal vein occlusion or central retinal vein occlusion, and noninfectious uveitis affecting the posterior segment of the eye.
Mitchell, P, et al. Early vs. Late Switch to Dexamethasone Intravitreal Implant in Anti-VEGF Nonresponders With DME in the AUSSIEDEX Study. Poster number: PO426. The American Academy of Ophthalmology Meeting; October 12-15 2019.