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Subconjunctival sustained release 5-fluorouracil.

D L Blandford1, T J Smith, J D Brown

  • 1Department of Ophthalmology, University of Kentucky, Lexington.

Investigative Ophthalmology & Visual Science
|November 1, 1992
PubMed
Summary
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A novel sustained-release device for 5-fluorouracil (5-FU) effectively lowered intraocular pressure in monkeys for three months. This drug delivery system shows promise for managing ocular conditions without significant toxicity.

Area of Science:

  • Ophthalmology
  • Drug Delivery Systems
  • Biomaterials

Background:

  • Elevated intraocular pressure (IOP) is a major risk factor for glaucoma.
  • Current treatments for IOP can have limitations and side effects.
  • Sustained drug delivery offers potential for improved IOP management.

Purpose of the Study:

  • To develop and evaluate a novel sustained-release device for 5-fluorouracil (5-FU).
  • To assess the efficacy and safety of the 5-FU device in reducing IOP in a primate model.

Main Methods:

  • A 12 mg 5-fluorouracil (5-FU) pellet was coated with a polymer mixture to create a sustained-release device.
  • The device was implanted subconjunctivally in rabbit eyes to determine release kinetics (approx. 1 mg/d for over 10 days).
  • 5-FU or placebo devices were implanted in cynomolgus monkey eyes after posterior lip sclerotomy for a 3-month study.

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Main Results:

  • In control monkey eyes, IOP normalized within 1 week.
  • In treatment monkey eyes, IOP remained significantly lower throughout the 3-month experimental period.
  • No adverse effects such as impaired wound healing, corneal toxicity, inflammation, or ciliary body damage were observed in rabbits or monkeys.

Conclusions:

  • The developed sustained-release 5-FU device effectively lowers IOP in a primate model.
  • The device demonstrates a favorable safety profile with no significant ocular toxicity.
  • This novel drug delivery system holds potential for long-term IOP management in ophthalmology.