Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 0.05% Voclosporin Ophthalmic Solution (VOS)
0.05% Voclosporin · 1 trial · 2 indications
Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.
| Arm | Type | Description |
|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS) | EXPERIMENTAL | 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| 0.10% VOS | EXPERIMENTAL | 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| 0.20% VOS | EXPERIMENTAL | 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| Vehicle Ophthalmic Solution | PLACEBO_COMPARATOR | Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks |
| Name | Type | Description |
|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS) | DRUG | 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| 0.10% VOS | DRUG | 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| 0.20% VOS | DRUG | 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| Vehicle Ophthalmic Solution | DRUG | Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks |
Inclusion Criteria: * Be at least 18 years of age. * Have a documented history of Dry Eye prior to Visit 1. * Willing and able to follow protocol procedures and instructions. Exclusion criteria: * Have undergone cataract or LASIK surgery within 1 year prior to Visit 1. * Recent or current evidenc...
Top 2 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Vadadustat |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE2 | Fostamatinib |
0.05% Voclosporin is an investigational small molecule developed by Aurinia Pharmaceuticals Inc (AUPH) as an ophthalmic solution for Dry Eye Syndrome. It is also known as 0.05% Voclosporin Ophthalmic Solution (VOS). The asset has completed a Phase 2 clinical program and is not approved for commercial use.
0.05% Voclosporin is being studied for the treatment of Dry Eye Syndrome, also referred to as keratoconjunctivitis sicca. It is formulated as a topical ophthalmic solution. The program is investigational, so the asset is not currently approved for treating dry eye or any other condition.
Aurinia Pharmaceuticals Inc, which trades under the ticker AUPH, is the developer of 0.05% Voclosporin Ophthalmic Solution. The company sponsored the clinical program evaluating the asset in Dry Eye Syndrome. Aurinia is the sole developer named for this ophthalmic formulation.
0.05% Voclosporin is in Phase 2 development for Dry Eye Syndrome. The program includes one completed Phase 2 trial, and no trials are currently active. Because the asset remains investigational, it has not received FDA approval for any indication.
0.05% Voclosporin has been evaluated in one Phase 2 trial, NCT04147650, titled a dose ranging study to assess the efficacy and safety of Voclosporin Ophthalmic Solution in subjects with Dry Eye Syndrome. The trial enrolled 508 participants across United States sites, was randomized, double blind, and placebo controlled, and is completed.
Yes. 0.05% Voclosporin Ophthalmic Solution, abbreviated VOS, is the same asset as 0.05% Voclosporin. VOS is the full name used for the topical eye drop formulation that Aurinia Pharmaceuticals Inc (AUPH) studied in Dry Eye Syndrome during its completed Phase 2 trial.