Drugs / CSF-1
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | presbyopia | 2023-01-03 | “today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational CSF-1” orasis-pharma.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03885011 | Feb → Jul 2019 | presbyopia | Orasis Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT05393895 | Apr → Dec 2022 | presbyopia | Orasis Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04599972 | Oct 2020 → Jan 2022 | presbyopia | Orasis Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 3 | NCT04599933 | Oct 2020 → Feb 2022 | presbyopia | Orasis Pharmaceuticals Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-01-27 | Orasis Pharmaceuticals Ltd. | Results New Data Demonstrate Qlosi™ Is Pupil Selective With Ciliary Muscle Movement No Different Than A Balanced Salt Solution (BSS) Control orasis-pharma.com ↗
In an imaging study from the Bascom Palmer Eye Institute, Qlosi’s low-concentration formulation with 0.4% pilocarpine significantly reduced pupil diameter while demonstrating ciliary muscle movement the same as BSS control1 |
| 2023-02-20 | Orasis Pharmaceuticals Ltd. | Regulatory FDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia orasis-pharma.com ↗ |
| 2023-01-03 | Orasis Pharmaceuticals Ltd. | Regulatory Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia orasis-pharma.com ↗
today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). |
| 2022-04-23 | Orasis Pharmaceuticals Ltd. | Results Orasis Pharmaceuticals Announces Phase 2b Trial Efficacy and Safety Results of CSF-1 at the 2022 ASCRS Annual Meeting orasis-pharma.com ↗
Two presentations on the Phase 2b clinical trial show CSF-1 met the primary endpoints and achieved statistically significant and clinically meaningful improvements in distance-corrected near visual acuity (DCNVA) for participants with presbyopia |
| 2022-04-21 | Orasis Pharmaceuticals Ltd. | Results Orasis Pharmaceuticals Announces Positive Phase 3 Topline Results of Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia orasis-pharma.com ↗
In both trials, CSF-1 met its primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. |
| 2019-10-10 | Orasis Pharmaceuticals Ltd. | Results Orasis Pharmaceuticals Announces CSF-1 Eye Drop Successfully Met Primary Endpoint in Phase 2b Clinical Study in Presbyopia orasis-pharma.com ↗
today announced its CSF-1 eye drop has successfully met the primary endpoint in a Phase 2b clinical study in individuals with presbyopia. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CSF-1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05393895 ↗ |
| Known as | pilocarpine | “IMPLICATIONS: CSF-1, a low-dose pilocarpine ophthalmic solution, demonstrated superiority to vehicle in improving near vision in individuals with presbyopia without...” PMID 38216351 ↗ Jan 2024 |
| Route | Other | “dose twice a day in both eyes with a single drop” NCT03885011 ↗ |