Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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, pain, drug hypersensitivity, and vitreous detachment. It is in Phase 1 clinical development. Vitrase has been studied in clinical trials for these conditions, but it is not approved and remains investigational.
Vitrase is a small molecule that acts as a spreading agent. It is being studied for its ability to clear severe vitreous hemorrhage and to reduce hypersensitivity reactions. The specific molecular target has not been disclosed in the available information.
Vitrase is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of Vitrase for various ophthalmic and hypersensitivity conditions.
Vitrase is in Phase 1 clinical development. While some completed trials were Phase 3, the current development stage is Phase 1. Vitrase is investigational and has not been approved by regulatory authorities.
Vitrase has been studied in several clinical trials, including NCT00198419 and NCT00198458 for drug hypersensitivity, NCT00198484 as a spreading agent for pain, and NCT00198497 for vitreous hemorrhage. All trials are completed, with a total enrollment of 1260 participants.
Vitrase is also known as ovine hyaluronidase. Clinical trials such as NCT00198419 and NCT00198458 specifically studied hypersensitivity reactions to Vitrase (ovine hyaluronidase). This alternative name helps identify the drug in research literature.