Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dorzolamide-timolol · 2 trials · 5 indications
Change in mean CST on spectral domain optical coherence tomography from baseline to the final visit
Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment
| Arm | Type | Description |
|---|---|---|
| Dorzolamide-timolol | ACTIVE_COMPARATOR | Topical dorzolamide-timolol twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals. |
| Artificial tears | PLACEBO_COMPARATOR | Topical artificial tears twice daily for the study duration. All patients will continue to receive intravitreal anti-VEGF injections at regularly scheduled intervals. |
| Name | Type | Description |
|---|---|---|
| Dorzolamide-timolol | DRUG | Topical eye drop (active comparator) used twice daily for study duration |
| Artificial tears | OTHER | Topical eye drop (placebo comparator) used twice daily for study duration |
Inclusion Criteria: 1. Active choroidal neovascularization (CNV) due to AMD. 2. Prior treatment with at least 4 injections of anti-VEGF agents in the past 6 months and persistent intraretinal and/or subretinal fluid on SD-OCT at each visit during this period. 3. Baseline CST ≥ 270 µm on SD-OCT auto...
Dorzolamide-timolol is an investigational small molecule being studied for neovascular age-related macular degeneration and wet macular degeneration. It is a fixed combination eye drop being evaluated as an add-on to anti-vascular endothelial growth factor injections for these retinal conditions.
Dorzolamide-timolol is being developed by Atlantic International Corp., a company trading under the ticker ATLN. The drug is in Phase 2 clinical development for ophthalmology indications.
Dorzolamide-timolol is in Phase 2 clinical development. It is investigational and not approved by the FDA. Two Phase 2 trials have been completed, one with 52 participants and another with 14 participants.
Dorzolamide-timolol has completed two Phase 2 trials: NCT03034772, a placebo-controlled study of 52 patients with neovascular age-related macular degeneration or wet macular degeneration, and NCT02571972, a study of 14 patients with wet macular degeneration, diabetic macular edema, or retinal vein occlusion.
Dorzolamide-timolol combines a carbonic anhydrase inhibitor with a beta-blocker. It is being studied as an eye drop to be used alongside anti-vascular endothelial growth factor injections for the treatment of wet age-related macular degeneration.