Fluocinolone acetonide intravitreal implant stabilises IOP among Diabetic Macular Edema patients

A recent analysis of the phase 4 PALADIN study suggests that the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant, known as ILUVIEN, has a positive impact on patients with diabetic macular edema (DME) over a 36-month period. The research indicates that FAc implantation is associated with stable intraocular pressure (IOP) and visual acuity in DME patients.

The PALADIN study is a non-randomized, open-label observational study that included 202 eyes from 159 patients with DME. These patients received the 0.19-mg FAc implant following a successful prior steroid challenge, in line with the US label indication. In the treatment of DME, intravitreal anti-vascular endothelial growth factor (VEGF) agents are the standard of care. However, frequent injections can lead to issues with patient adherence and potentially result in suboptimal outcomes. Corticosteroids are considered a second-line therapy due to their association with increased IOP and cataract formation.

● Patients who experienced IOP elevations >30 mmHg or required IOP-lowering medication or procedures generally maintained stable best-corrected visual acuity after receiving the FAc implant.

● The analysis showed that 77.95% of eyes with an IOP response ≤25 mmHg after a previous steroid challenge remained stable over 36 months post-FAc implant. While the mean IOP increased post-FAc, overall IOP values remained relatively stable without significant differences at the 36-month mark compared to baseline.

● At 36 months post-FAc, eyes had a 32.5% probability of an IOP elevation to >25 mmHg and a 15.6% probability of an IOP elevation to >30 mmHg. However, only 7.4% of eyes had an IOP >30 mmHg during a study visit, and most exceeded the threshold only once.

● The probability of needing IOP-lowering medication at any point by month 36 was 38.3%. Most eyes (78%) maintained IOP ≤25 mmHg over the 36-month period, and nearly 97% of eyes had an IOP value ≤25 mmHg at the last visit if the prior steroid challenge reported similar values.

The data from this study suggest that IOP increases associated with the 0.19-mg FAc implant in DME patients can be predictable and manageable, ultimately leading to improved visual outcomes. These findings provide valuable insights into the use of long-term, low-dose steroid delivery for stabilizing DME disease status and supporting patients' visual health. Future research may explore further aspects of the implant's effects on retinal structure and patient-related outcomes.

Reference:

Roth DB, Eichenbaum D, Malik D, et al. 0.19-mg fluocinolone acetonide intravitreal implant for diabetic macular edema: intraocular pressure-related effects over 36 months [published online ahead of print, 2023 Aug 14]. Ophthalmol Retina. 2023;S2468-6530(23)00373-1. doi:10.1016/j.oret.2023.08.004