Safety and tolerability of pooled human immune globulins after topical ophthalmic administration in New Zealand White rabbits.
Cutan Ocul Toxicol
; 43(3): 227-231, 2024 Sep.
Article
in En
| MEDLINE
| ID: mdl-39086095
ABSTRACT
PURPOSE:
To evaluate the safety and tolerability of pooled human immune globulins, Flebogamma® 5% DIF and Flebogamma® 10% DIF, administered by topical ophthalmic instillation to New Zealand White (NZW) rabbits.METHODS:
Male NZW rabbits were used in this study. In the acute single dose tolerability study, rabbits (n = 12) received a single topical dose of Flebogamma® 5% DIF. In the two-week repeated-dose tolerability study, rabbits (n = 5 for each group) were administered either Flebogamma® 5% DIF or Flebogamma® 10% DIF by topical bilateral administration four times daily (q.i.d.) between 8 am and 6 pm for a period of two weeks. Full ophthalmic examinations were conducted to evaluate ocular tolerability at baseline, Day 7, and Day 14.RESULTS:
In the acute single dose study, mild hyperaemia was observed in 1 out of 4 eyes at each 4 h and 24 h post-instillation of Flebogamma® 5% DIF. In the repeated dose study, no ocular signs were detected after q.i.d. topical instillation of Flebogamma® 5% DIF, while Flebogamma® 10% DIF resulted in mild hyperaemia in 8 out of 10 eyes on Day 7, and 5 out of 10 eyes on Day 14. No positive corneal fluorescein staining was detected. Schirmer tear test results were unremarkable. No other ocular signs were observed. Administration of immune globulins had no effect on intraocular pressure.CONCLUSIONS:
Flebogamma® 5% DIF and Flebogamma® 10% DIF were well-tolerated by NZW rabbits following single and repeat dose topical ophthalmic administration, supporting the future development of topical pooled human immune globulins for the treatment of ocular surface disease.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Ophthalmic Solutions
/
Administration, Ophthalmic
Limits:
Animals
/
Humans
/
Male
Language:
En
Journal:
Cutan Ocul Toxicol
Journal subject:
DERMATOLOGIA
/
OFTALMOLOGIA
/
TOXICOLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Estados Unidos
Country of publication:
Reino Unido