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Research Report
Vitreosolve: A Comprehensive Analysis of its Development and Discontinuation in Pharmacologic Vitreolysis
I. Introduction to Vitreosolve
A. Overview and Identification
Vitreosolve was an investigational pharmaceutical agent developed within the field of pharmacologic vitreolysis. This field seeks to utilize non-surgical methods, primarily intravitreal drug delivery, to modify the structure of the vitreous humor and its interface with the retina, thereby treating or preventing various ocular pathologies associated with vitreoretinal adhesion or traction.[1] The vitreous humor, a gel primarily composed of water, collagen fibrils, and hyaluronan, plays a crucial role in maintaining eye structure but can contribute to diseases like diabetic retinopathy, macular holes, and vitreomacular traction when age-related or pathological changes occur, particularly incomplete posterior vitreous detachment (PVD).[1]
Vitreosolve was distinctively classified as a non-enzymatic agent, setting it apart from other vitreolytic approaches explored concurrently, such as those employing enzymes like plasmin, microplasmin (ocriplasmin), hyaluronidase, or dispase to cleave specific molecular components of the vitreous or vitreoretinal interface.[1] It was identified as a proprietary small molecule formulation belonging to the carbomide family, specifically characterized as being urea-based.[1] The intended route of administration was via intravitreal injection directly into the vitreous cavity.[10]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2009/05/27 | Phase 3 | UNKNOWN | |||
2008/04/22 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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