Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
0.05% Voclosporin is an investigational ophthalmic solution being studied for the treatment of Dry Eye Syndrome, also known as Keratoconjunctivitis Sicca. It is a small molecule developed by Aurinia Pharmaceuticals Inc (AUPH) and is currently in Phase 2 clinical development for this condition.
0.05% Voclosporin is a small molecule ophthalmic solution. Its specific molecular target is not disclosed in the available information. The drug is being investigated for its efficacy and safety in treating Dry Eye Syndrome, a condition characterized by insufficient tear production or excessive tear evaporation.
0.05% Voclosporin is being developed by Aurinia Pharmaceuticals Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AUPH. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Dry Eye Syndrome.
0.05% Voclosporin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 dose-ranging study has been completed to assess its efficacy and safety in patients with Dry Eye Syndrome.
0.05% Voclosporin has one completed Phase 2 clinical trial, identified by the National Clinical Trial number NCT04147650. This was a randomized, double-blind, placebo-controlled dose-ranging study that enrolled 508 participants in the United States to evaluate the drug's efficacy and safety in subjects with Dry Eye Syndrome.
0.05% Voclosporin refers to a specific ophthalmic formulation of voclosporin, a calcineurin inhibitor. The 0.05% concentration is being studied specifically for topical use in the eye to treat Dry Eye Syndrome. This formulation is distinct from other forms of voclosporin that may be used for different indications.