Drugs / Eybelis ophthalmic solution 0.002%
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | EYBELIS Ophthalmic Solution 0.002% | borderline glaucoma | — | “Santen and Ube Industries have, in a phased manner, filed for the treatment’s marketing approval also in Asia” santen.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05279716 | Feb → Dec 2022 | borderline glaucoma, low tension glaucoma, ocular hypertension | Santen Pharmaceutical Asia Pte. Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-02-02 | Santen Gmbh | Regulatory Santen and Ube Announces U.S. FDA Acceptance of New Drug Application for STN10117 (DE-117) (JAN: Omidenepag Isopropyl) as a Treatment for Patients with Glaucoma and Ocular Hypertension santen.com ↗ |
All press releases naming this drug 2 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eybelis ophthalmic solution 0.002% | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05279716 ↗ |
| Route | Other | “Ophthalmic eye drop” NCT05279716 ↗ |