Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ovine hyaluronidase, Hyaluronidase
Vitrase · 6 trials · 5 indications
Physician evaluation of effectiveness of Vitrase as an adjuvant and overall satisfaction, via questionnaire;
laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula \& at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved
Laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula \& at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved
The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28
Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.
| Arm | Type | Description |
|---|---|---|
| Vitrase | EXPERIMENTAL | ovine hyaluronidase injection 150 USP Units in 1 mL solution. Single dose of Vitrase will be administered as an adjuvant prior to ophthalmologic surgery |
| Placebo | PLACEBO_COMPARATOR | Single Saline solution intravitreal injection |
| Observation | NO_INTERVENTION | Observation only, no medication or intravitreal injection |
| Name | Type | Description |
|---|---|---|
| Vitrase | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Scheduled for an ophthalmic surgical procedure Exclusion Criteria: * Documented history of hypersensitivity to hyaluronidase or any other ingredient in Vitrase * Known history of hypersensitivity reaction to bee or wasp venom * Needing enhanced absorption and dispersion of d...
Vitrase is an investigational small molecule being developed for vitreous hemorrhage, drug hypersensitivity, vitreous detachment, and pain. It is in Phase 1 clinical development for these indications. The drug is being studied for its potential to clear severe vitreous hemorrhage associated with diabetic retinopathy.
Vitrase is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for conditions including vitreous hemorrhage and drug hypersensitivity.
Vitrase is in Phase 1 clinical development. It has completed two Phase 1 trials studying hypersensitivity reactions, as well as two Phase 3 trials for vitreous hemorrhage clearance. However, the drug remains investigational and is not FDA approved.
Vitrase has completed four clinical trials. Two Phase 1 trials (NCT00198419 and NCT00198458) studied hypersensitivity reactions in healthy volunteers. Two Phase 3 trials (NCT00198497 and NCT00198510) evaluated safety and efficacy for clearing severe vitreous hemorrhage in patients with diabetic retinopathy.
Vitrase is also known as ovine hyaluronidase, as indicated in the clinical trial titles. The Phase 1 trials were specifically titled 'Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase),' confirming that Vitrase and ovine hyaluronidase refer to the same drug.