BLA 125422, held by Thrombogenics, Inc. Ocriplasmin.
As of Nov 13, 2026, BLA 125422 (Jetrea), held by Thrombogenics, Inc, was first approved by FDA on Oct 17, 2012, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 13, 2014 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2012 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jetrea2.5MG/ML · injectable; intravitreal | Ocriplasmin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2017 | Supplement 38Labeling · Standard review | Approved | |
| Mar 27, 2016 | Supplement 37Labeling · Standard review | Approved | |
| Jun 13, 2014 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Oct 17, 2012 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
