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SAR366234 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAR366234 (Dose 1) | EXPERIMENTAL | A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| SAR366234 (Dose 2) | EXPERIMENTAL | A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days |
| SAR366234 (Dose 3) | EXPERIMENTAL | A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| SAR366234 (Dose 4) | EXPERIMENTAL | A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days |
| SAR366234 (Dose 5) | EXPERIMENTAL | A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days |
| Latanoprost | ACTIVE_COMPARATOR | A dose of Latanoprost will be administered 1 drop per eye per day for 28 days |
| Name | Type | Description |
|---|---|---|
| Latanoprost | DRUG | - |
| SAR366234 | DRUG | - |
Inclusion criteria: * Male or female patients ≥18 years of age. * Patients diagnosed with OAG (including pseudoexfoliation and pigment dispersion syndromes and patients with a history of narrow angle closure with a patent peripheral iridotomy) or OHT. * Documented intraocular pressure (IOP) fulfill...
SAR366234 is an investigational small molecule developed by Sanofi for open angle glaucoma and ocular hypertension. It is a topical eye drop candidate that has been studied in a Phase 1 clinical trial. It is not approved for any indication and remains in clinical development.
SAR366234 is being developed to lower intraocular pressure in patients with open angle glaucoma or ocular hypertension. It was tested as a topical eye drop in a 28-day dose-escalation study that compared five escalating dose levels of SAR366234 against one dose of latanoprost, an approved glaucoma medication.
SAR366234 is developed by Sanofi, the French pharmaceutical company whose shares trade on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the Phase 1 study of the compound conducted in the United States.
SAR366234 is in Phase 1 clinical development. Its only recorded trial, NCT02531152, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA for open angle glaucoma, ocular hypertension, or any other indication.
SAR366234 has been evaluated in one clinical trial, NCT02531152, a Phase 1 study titled a 28-day repeated topical study of five escalating dose levels of SAR366234 and one dose of latanoprost in patients with open angle glaucoma or ocular hypertension. The trial enrolled 54 patients in the United States and is completed.
NCT02531152 was a randomized, active-controlled Phase 1 study in 54 adults aged 18 and older with open angle glaucoma or ocular hypertension. Participants received one of five escalating topical dose levels of SAR366234 or a single dose of latanoprost over 28 days of repeated dosing. It was not blinded and enrolled no healthy volunteers.