Scholarlink

Introduction <p>Unintentional ocular exposure to epinephrine nasal spray (10&#xa0;mg/mL epinephrine) is a potential safety concern. Although epinephrine is used in multiple ocular formulations, unintentional ocular administration of epinephrine nasal spray was assessed to determine tolerability and support the overall safety profile.</p> Methods <p>A non-GLP ocular tolerability study was conducted using six naïve New Zealand White rabbits (3 males, 3 females). Vehicle control or epinephrine nasal spray (1&#xa0;mg) was applied to the right or left eye, respectively, once on Day 1. Animals were monitored over seven days for mortality, clinical signs, body weight changes, ophthalmic findings, ocular irritation (using the Modified Hackett-McDonald Scoring System), and gross necropsy findings.</p> Results <p>Epinephrine nasal spray was well tolerated with no mortality, clinical abnormalities, or changes in body weight. Ophthalmic examinations via indirect ophthalmoscopy and slit-lamp biomicroscopy revealed no signs of irritation or ocular toxicity. No gross pathological changes were noted at necropsy.</p> Conclusion <p>A single topical administration of epinephrine nasal spray (10&#xa0;mg/mL) in rabbit eyes was not associated with any adverse effects, indicating a low risk of ocular toxicity. These results support the safety of epinephrine nasal spray in the event of unintentional ocular exposure and taken together with epinephrine’s use in other ocular formulations, suggest that no further nonclinical ocular studies are necessary.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Low risk of ocular toxicity following topical ocular administration of epinephrine nasal spray: implications for unintentional exposure

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月7日

查看全文
  • Anne K. Ellis,
  • David M. Fleischer,
  • Carlos A. Camargo Jr.,
  • Richard Lowenthal,
  • Sarina Tanimoto

摘要

Introduction

Unintentional ocular exposure to epinephrine nasal spray (10 mg/mL epinephrine) is a potential safety concern. Although epinephrine is used in multiple ocular formulations, unintentional ocular administration of epinephrine nasal spray was assessed to determine tolerability and support the overall safety profile.

Methods

A non-GLP ocular tolerability study was conducted using six naïve New Zealand White rabbits (3 males, 3 females). Vehicle control or epinephrine nasal spray (1 mg) was applied to the right or left eye, respectively, once on Day 1. Animals were monitored over seven days for mortality, clinical signs, body weight changes, ophthalmic findings, ocular irritation (using the Modified Hackett-McDonald Scoring System), and gross necropsy findings.

Results

Epinephrine nasal spray was well tolerated with no mortality, clinical abnormalities, or changes in body weight. Ophthalmic examinations via indirect ophthalmoscopy and slit-lamp biomicroscopy revealed no signs of irritation or ocular toxicity. No gross pathological changes were noted at necropsy.

Conclusion

A single topical administration of epinephrine nasal spray (10 mg/mL) in rabbit eyes was not associated with any adverse effects, indicating a low risk of ocular toxicity. These results support the safety of epinephrine nasal spray in the event of unintentional ocular exposure and taken together with epinephrine’s use in other ocular formulations, suggest that no further nonclinical ocular studies are necessary.