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New research · Ophthalmology
Cutaneous and ocular toxicology · 2d
Animal / preclinicalCutaneous and ocular toxicology · 2026

Long-term ocular safety and systemic exposure of doxycycline hyclate ophthalmic solution in juvenile rabbits: a 270-day preclinical GLP study.

Yi-Chau Chen, Shi-Ju Huang, Hsin-Ming Chen … Chi-Jr Liao
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OphthalmologyAnimal / preclinical

Topical doxycycline eye drops caused no toxicity in rabbits over 9 months of twice-daily use.

Long-term ocular safety and systemic exposure of doxycycline hyclate ophthalmic solution in juvenile rabbits: a 270-day preclinical GLP study.

Yi-Chau Chen … Chi-Jr Liao
Cutaneous and ocular toxicology · 2026
Purpose

This study evaluated the chronic ocular safety and systemic exposure of a doxycycline hyclate ophthalmic solution following repeated topical administration in a juvenile model.

Methods

A 9-month Good Laboratory Practice (Good Laboratory Practice) repeat-dose study was conducted in juvenile Dutch Belted rabbits.

0.25
Results
0.25
mg/eye
highest dose tested still showed no eye or body-wide toxicity
More results

No treatment-related mortality, adverse clinical findings, or ocular tissue alterations were observed.

Ophthalmic examinations and clinical pathology showed no test article-related toxicity.

Systemic exposure increased dose-dependently, with T max generally observed 1-12 hours post-dose on Days 1, 180, and 270.

More results

Exposure demonstrated low accumulation and was independent of sex.

“
Conclusion · 1 of 3

Twice-daily topical doxycycline hyclate ophthalmic solution was well tolerated in juvenile rabbits for 9 months.

Conclusion · 2 of 3

No systemic or ocular toxicity was identified, establishing the No-Observed-Adverse-Effect Level (No-Observed-Adverse-Effect Level) at 0.25 mg/eye (1 mg/day).

Conclusion · 3 of 3

These findings support the safety of long-term ocular exposure to doxycycline hyclate for chronic applications.

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