Abstract
Purpose :
In current clinical practice, undertreatment with shorter duration intravitreal pharmacotherapies can lead to frequent recurrence of DME and may lead to irreversible vision loss. This study aims to evaluate the real-world safety and efficacy outcomes of the long-acting 0.19mg FAc implant in patients with DME.
Methods :
This retrospective cohort study included 94 eyes (58 patients). Eyes included in the study received at least one FAc implant for the treatment of DME after receiving a course of corticosteroids without a clinically significant rise in intraocular pressure. Data was collected from visits 18 months prior to FAc (avg. 14.6) and at least 3 years of follow-up post-FAc (avg. 51 months). Several efficacy and safety metrics were measured including visual acuity (VA), central subfield thickness (CST), supplemental treatments, and intraocular pressure (IOP).
Results :
Mean baseline VA was stable from pre-FAc (61.5±1.5 letters) to post-FAc (58.2±0.3 letters). Mean CST 1 month prior to FAc was 427.6±20.8µm and significantly declined to 310.6 ± 11.4µm (p<0.05). Yearly treatment burden was significantly reduced from 4.6 treatments pre-FAc to 2.3 treatments post-FAc (p<0.05 by two-tailed, paired student’s t-test). During 51.2 months of follow-up, 40.4% of eyes were re-treated with at least 1 additional FAc implant, and the mean time to re-treatment was 25.7±7.9 months. 21.3% of eyes did not require additional therapy of any kind. A non-significant increase in IOP was observed from 15.8 mmHg at baseline to 16.3 mmHg at the last visit. Finally, no new safety signals were identified during this study.
Conclusions :
In real-world clinical practice, patients treated with shorter duration therapies have increased rates of non-adherence due to the need for higher injection frequencies. This high injection burden can lead to recurrent DME and irreversible vision loss. The 0.19 mg FAc implant is the only FDA-approved long-acting therapy that can treat DME continuously for up to 3 years. The current study shows that the 0.19mg FAc implant maintained or improved visual acuity, significantly improved anatomic outcomes, led to a significant reduction in overall treatment burden, and maintained a manageable safety profile. This study supports that the FAc implant provides a durable treatment option that can reduce the burden of care for patients with DME.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.