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Long-Acting Treatment, Earlier

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When considering treatment options for managing diabetic macular edema (DME), the importance of timely and effective care cannot be overstated. Recent clinical studies have highlighted the potential that earlier use of a long-term steroid treatment for DME can provide patients with improved visual outcomes. The PALADIN Study, in particular, illustrates the potential of administering the ILUVIEN® intravitreal implant at an earlier stage in the DME treatment process. Studies like this suggest that early ILUVIEN application is effective, long-lasting, and helps reduce the need for frequent treatments.


Significant Studies

Clinical studies test a specific treatment among patients with a specific diagnosis. The data are then reviewed and shared by medical professionals for the medical community to take into consideration when prescribing specific treatment courses. ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Please see important safety information below.

Clinical studies like FAME and PALADIN demonstrate the effectiveness of early DME treatment with the ILUVIEN intravitreal implant. These studies showcase the benefits that earlier use of ILUVIEN treatment can have on vision improvement and the reduction in treatment burden (treatment frequency) and retinal thickness variability (changes in retinal thickness caused by DME progression and treatment).

ILUVIEN with CONTINUOUS MICRODOSING™ Delivery was evaluated in the FAME 3-year studies. These pivotal trials showed a sustained improvement in visual acuity (measurement of eye sight at a distance) and a reduction in retinal edema (inflammation) in patients whose DME persisted even with prior treatment. In the trials, average retinal thickness was reduced and maintained throughout the 36-month study period. Notably, no patient who received ILUVIEN after prior steroid injections required another surgery for elevated eye pressure.[1]

The PALADIN Study also supports the visual-outcome benefits of using ILUVIEN earlier in DME treatment. This 3-year, real-world observational study tracked patients who received the ILUVIEN intravitreal implant and observed their safety, visual, and treatment-related outcomes over 36 months. All participants were DME patients who had previously received corticosteroid treatment without a clinically significant rise in intraocular pressure (IOP). Patients with fewer treatments before ILUVIEN experienced the highest vision improvements, further suggesting the importance of early ILUVIEN treatment for improved visual results.[2]


Positive Results with Early Application

In bridging the treatment gap and controlling inflammation, long-term steroid treatments like ILUVIEN show potential for effectively managing DME with early application. The PALADIN Study reinforced the benefits of introducing ILUVIEN early in DME treatment. The highest gains in vision were noted in patients with fewer (≤ 6) prior treatments, showing an increase in 5.7 letters compared with the baseline. With results like these, making use of early, long-term steroid treatment for DME patients can be critical for optimal outcomes!

ILUVIEN provides treatment for up to 36 months and may yield visual and anatomical improvements. If you are already on DME treatment, are tired of monthly injections, or are looking for more durable treatment options, ILUVIEN may be right for you. Visit your eye doctor for a detailed evaluation to assess your condition and determine if you are a candidate for ILUVIEN. Make an appointment today to talk with your doctor and see if ILUVIEN could be the right treatment option for you.


[1] Campochiaro et al. Ophthalmology 2012 Oct;119(10):2125-32

[2] Singer MA, Sheth V, Mansour SE, Coughlin B, Gonzalez VH. Ophthalmology. 2022 Jan 19:S0161- 6420(22)00067-7. doi: 10.1016/j.ophtha.2022.01.015.

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