Toxicology study of long-term administration of rhKGF-2 eye drops on rabbit corneas

JianQiu Cai1, Wenqing Li2, Jinghang Li3

  • 1Wenzhou Medical University, Chashan University Park, Wenzhou, 325035, China; Department of Ophthalmology, The Affiliated Second Hospital of Wenzhou Medical University, #109 Xueyuan West Road, Wenzhou 325027, China.

Insights

Recombinant human keratinocyte growth factor-2 (KGF-2) eye drops caused temporary ocular irritation in rabbits at high doses. However, KGF-2 eye drops demonstrated no significant corneal toxicity or systemic effects, suggesting a favorable safety profile for corneal repair.

Area of Science:

  • Ophthalmology
  • Regenerative Medicine
  • Toxicology

Background:

  • Keratinocyte growth factor-2 (KGF-2) is known to promote corneal repair by regulating cell regeneration, migration, and stem cell activation.
  • Potential carcinogenic properties and adverse effects of KGF-2 in high-dose, long-term ocular treatments remain largely unreported.

Purpose of the Study:

  • To investigate the potential toxic effects of ocular administration of recombinant human KGF-2 eye drops in a rabbit model.
  • To assess the safety profile of KGF-2 eye drops, particularly concerning corneal health and systemic toxicity.

Main Methods:

  • New Zealand white rabbits were administered varying doses of recombinant human KGF-2 eye drops.
  • Ocular examinations, serum biochemistry analyses, and pathological examinations were conducted to evaluate treatment effects.

Main Results:

  • Animals in medium- and high-dose groups exhibited transient ocular irritant reactions during administration.
  • These irritant reactions were deemed harmless to the cornea and resolved upon cessation of drug administration.
  • Serum biochemistries and pathological examinations were largely unremarkable, indicating no significant systemic toxicity or structural damage.

Conclusions:

  • Over-dosed ocular administration of KGF-2 eye drops can induce temporary, harmless ocular irritation in rabbits.
  • The study suggests that KGF-2 eye drops do not cause significant corneal damage or systemic adverse effects, supporting its potential therapeutic use.
  • Further research may be warranted to fully elucidate the long-term safety and efficacy of KGF-2 in corneal repair therapies.

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