hyaluronidase (ovine)
Trade name: Vitrase
Approved
May 5, 2004
Hyaluronidases are a family of enzymes that catalyse the degradation of hyaluronic acid. Karl Meyer classified these enzymes in 1971, into three distinct groups, a scheme based on the enzyme reaction products. The three main types of hyaluronidases are two classes of eukaryotic endoglycosidase hydrolases and a prokaryotic lyase-type of glycosidase. — Wikipedia
Clinical trial activity
7 trials · 2 clinical orgs · 2 marketing orgs
Earliest trial started Nov 1, 1998 (NCT00198510)
Timeline
1990s
- Jan 1, 1998
Bausch & Lomb — Earliest Phase 3 Sponsor(trial)
2000s
- Jan 1, 2004
Bausch & Lomb — Earliest Phase 1 Sponsor(trial)
- May 5, 2004
ISTA Pharmaceuticals — Earliest FDA Approval
- May 5, 2004
Bausch & Lomb — Marketing Organization
- May 5, 2004
Bausch & Lomb — NDA Secondary Org
- May 5, 2004
ISTA Pharmaceuticals — NDA Organization
- Jan 1, 2005
Bausch & Lomb — Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- HyaluronidaseSupplementation
Hyaluronidase supplementation
Approval history
- approvedPriority reviewMay 5, 2004
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaHyaluronidase ↗
- ChEMBLCHEMBL2108607 ↗
- ChEMBLCHEMBL1201636 ↗
Also known as
- hyaluronidase
- ovine hyaluronidase
- vitrase
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00198471 | Phase 2 | Jul 1, 2005 | Bausch & Lomb, ISTA Pharmaceuticals |
| NCT00198484 | Phase 3 | Oct 1, 2004 | Bausch & Lomb, ISTA Pharmaceuticals |
| NCT00198549 | Phase 4 | Sep 1, 2004 | Bausch & Lomb, ISTA Pharmaceuticals |
| NCT00198458 | Phase 1 | Jul 1, 2004 | Bausch & Lomb, ISTA Pharmaceuticals |
| NCT00198419 | Phase 1 | Mar 1, 2004 | Bausch & Lomb, ISTA Pharmaceuticals |
| NCT00198497 | Phase 3 | Jun 1, 1999 | Bausch & Lomb, ISTA Pharmaceuticals |
| NCT00198510 | Phase 3 | Nov 1, 1998 | Bausch & Lomb, ISTA Pharmaceuticals |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bausch & Lomb | For profit | 7 | 7 | 4 | 1998 |
| ISTA Pharmaceuticals | For profit | 7 | 0 | 4 | 1998 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bausch & Lomb | For profit | MKTG | May 5, 2004 |
| Bausch & Lomb | For profit | NDA2 | May 5, 2004 |
| ISTA Pharmaceuticals | For profit | NDA | May 5, 2004 |