Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication 1. INDICATIONS AND USAGE ROCKLATAN is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. FDA label
Also known as Xalatan 0.005% eye drops
latanoprost · 3 trials · 3 indications
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
| Arm | Type | Description |
|---|---|---|
| Timolol | ACTIVE_COMPARATOR | - |
| latanoprost | EXPERIMENTAL | - |
| latanoprost 75 ug | EXPERIMENTAL | - |
| latanoprost 100 ug | EXPERIMENTAL | - |
| latanoprost 125 ug | EXPERIMENTAL | - |
| latanoprost 50 ug | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Timolol | DRUG | Timolol 0.5% dosed twice-daily |
| latanoprost | DRUG | Latanoprost 0.005% ophthalmic solution dosed once-daily |
| latanoprost 75 ug | DRUG | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
| latanoprost 100 ug | DRUG | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
| latanoprost 125 ug | DRUG | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
| latanoprost 50 ug | DRUG | Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit. |
Inclusion Criteria: * Male or female of 18 years of age or under * Diagnosis of glaucoma * IOP of 22 mmHg or above in at least 1 eye Exclusion Criteria: * Require surgery for acute angle closure * Have had prior cyclodestructive procedures * Have a history of ocular trauma or surgery in either ey...
Top 5 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Travoprost |
| SpyGlass Pharma, Inc. | SGP | 5 | PHASE3 | Bimatoprost System, BIM-DRS |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | AGN-193408 |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN22530 |