Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ocriplasmin · 1 trial · 1 indication
VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.
| Arm | Type | Description |
|---|---|---|
| Ocriplasmin | EXPERIMENTAL | Ocriplasmin administered as a single intravitreal injection to the study eye at baseline |
| Sham injection | SHAM_COMPARATOR | Single sham injection to the study eye at baseline |
| Name | Type | Description |
|---|---|---|
| Ocriplasmin | DRUG | - |
| Sham injection | DRUG | - |
Inclusion Criteria: * Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function; * Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye; * BCVA of 20/800 or better in the non-study eye; * Provide written informed co...
Ocriplasmin is used for symptomatic vitreomacular adhesion, an eye condition in which the vitreous gel remains attached to the macula. It is being developed as a treatment for this condition in the field of ophthalmology.
Ocriplasmin is being developed by Alcon Inc., a company traded under the ticker ALC. Alcon is conducting clinical research on this drug for symptomatic vitreomacular adhesion.
Ocriplasmin is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Ocriplasmin has one completed Phase 3 clinical trial, identified as NCT01889251. This study, titled 'A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion,' enrolled 251 participants in Japan and was randomized, double-blind, and sham-controlled.
Yes, Ocriplasmin is also known as A01016. The Phase 3 clinical trial NCT01889251 refers to the drug as A01016, confirming that these names refer to the same investigational treatment for symptomatic vitreomacular adhesion.