Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
dorzolamide timolol · 2 trials · 2 indications
Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | combination of dorzolamide hydrochloride and timolol maleate |
| 2 | ACTIVE_COMPARATOR | Concomitant use of dorzolamide hydrochloride and timolol maleate |
| 3 | ACTIVE_COMPARATOR | timolol maleate |
| Name | Type | Description |
|---|---|---|
| dorzolamide hydrochloride (+) timolol maleate | DRUG | Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week |
| Comparator: timolol maleate | DRUG | timolol maleate 0.5%, 8-week |
| Comparator: dorzolamide hydrochloride | DRUG | dorzolamide hydrochloride 1%, 8-week |
| Comparator: dorzolamide HCl/timolol maleate + prostaglandin | DRUG | Combination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension. For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks. |
Inclusion Criteria: * Patients with glaucoma and ocular hypertension Exclusion Criteria: * History of ocular surgery within 3 months * Administration contradiction to timolol and dorzolamide
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 |
Dorzolamide timolol is used to treat glaucoma and ocular hypertension, conditions in which pressure inside the eye is elevated. It is a fixed-combination eye drop developed by Merck & Company, Inc. (ticker MRK) and studied in patients with glaucoma and ocular hypertension, including use as first line therapy.
Dorzolamide timolol targets CA2, or carbonic anhydrase II, as an inhibitor. Dorzolamide hydrochloride inhibits carbonic anhydrase II, while timolol maleate is a beta-adrenergic blocking agent. Together these two small molecule components reduce elevated intraocular pressure through complementary mechanisms in the eye.
Dorzolamide timolol is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck conducted the Phase 3 clinical program for the fixed-combination product, including studies identified as MK-0507A-153 and 0507A-149 in patients with glaucoma and ocular hypertension.
Dorzolamide timolol has been studied in Phase 3 clinical development. Two Phase 3 trials are recorded, both completed, with no trials currently active. The program enrolled 644 patients in total, and the studies were randomized, double-blind, and controlled.
Dorzolamide timolol was evaluated in two completed Phase 3 trials. NCT00546286 studied its effectiveness as first line therapy in 170 patients aged 18 years and older with glaucoma and ocular hypertension. NCT00449956 enrolled 474 patients aged 20 years and older with glaucoma and ocular hypertension. Both trials are completed.