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Long-acting fenofibrate-loaded microparticles for treating retinal disorders.

Sagun Poudel1, Yi Cui2, Tuo Meng1

  • 1Department of Pharmaceutics, Virginia Commonwealth University, Richmond, VA 23298, USA.

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|December 17, 2025
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Summary

Fenofibrate microparticles (Feno-MP) offer a novel, sustained intraocular delivery for Age-related Macular Degeneration (AMD) and Diabetic Retinopathy (DR). A single injection provided six months of therapeutic effects across multiple disease models.

Keywords:
Age-related macular degenerationDiabetic retinopathyIntravitreal injectionOcular drug deliveryPLGAPPARα agonist

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Area of Science:

  • Ophthalmology
  • Pharmacology
  • Biomaterials Science

Background:

  • Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are leading causes of vision loss.
  • Current anti-VEGF therapies require frequent intravitreal injections and have limited efficacy in a significant patient subset.
  • There is a critical need for alternative, non-VEGF therapies with sustained action for retinal disorders.

Purpose of the Study:

  • To develop and evaluate fenofibrate-loaded biodegradable microparticles (Feno-MP) for long-acting intraocular delivery.
  • To investigate the therapeutic efficacy of a single intravitreal injection of Feno-MP in preclinical models of DR and AMD.
  • To explore a non-VEGF, PPARα-dependent therapeutic strategy for retinal diseases.

Main Methods:

  • Formulation of large-sized fenofibrate-loaded biodegradable microparticles (Feno-MP) with high drug loading and sustained in vitro release (>6 months).
  • Intravitreal injection (IVT) of Feno-MP into streptozotocin (STZ)-induced diabetic rats (DR model), Vldlr-/- mice (wet AMD model), and Abca4-/-/Rdh8-/- mice (dry AMD model).
  • Assessment of therapeutic effects over 6 months, including electroretinogram (ERG) responses, leukostasis, blood-retinal barrier function, neovascularization, vascular leakage, photoreceptor survival, and mitochondrial function.

Main Results:

  • Feno-MP demonstrated sustained retinal drug levels for at least 6 months post-single IVT in rodent models without obvious toxicity.
  • In the DR model, Feno-MP restored ERG responses, decreased leukostasis, and enhanced blood-retinal barrier function.
  • In wet AMD models, Feno-MP reduced neovascularization and vascular leakage; in dry AMD models, it preserved photoreceptors and improved mitochondrial function.

Conclusions:

  • A single intravitreal injection of Feno-MP provides broad, sustained therapeutic benefits for diabetic retinopathy, wet AMD, and dry AMD models.
  • Repurposing oral fenofibrate into a long-acting intraocular delivery system via microparticles offers a promising new therapeutic avenue.
  • Feno-MP has the potential to reduce treatment burden to 1-2 intravitreal injections per year for patients with these retinal conditions.