Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)

Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study

The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.

Inclusion Criteria:

• Agreed to avoid disallowed meds

Exclusion Criteria:

• Known hypersensitivity to hyaluronidase and/or bee sting
• Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
• Atopic individuals assessed by medical history
• Topical/inhaled/systemic corticosteroids within 30 days
• Concurrent use of antihistamines or anti-inflammatory during study
• Active or chronic disease likely to affect immune function
• History of alcohol/drug abuse within 6 months