Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dexycu · 1 trial · 2 indications
The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).
| Arm | Type | Description |
|---|---|---|
| Dexamethasone intraocular injection | EXPERIMENTAL | Dexamethasone implant single injection in the treatment eye after cataract surgery. |
| Placebo | PLACEBO_COMPARATOR | Blank placebo single injection in the treatment eye after cataract surgery. |
| Name | Type | Description |
|---|---|---|
| Dexycu | DRUG | 5ul dexamethasone, concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone |
| Placebo | DRUG | Acetyl triethyl citrate |
Inclusion Criteria: 1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB). 2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intr...
Dexycu is an investigational small molecule being developed for the treatment of inflammation, specifically intraocular inflammation associated with cataract surgery. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Dexycu is a small molecule designed to treat inflammation, but its specific molecular target has not been disclosed. The drug is being studied for its ability to reduce intraocular inflammation following cataract surgery, based on its anti-inflammatory properties.
Dexycu is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating intraocular inflammation.
Dexycu is in Phase 3 clinical development. It has completed one Phase 3 trial, and the drug remains investigational, meaning it has not received FDA approval and is still undergoing clinical evaluation for its intended use.
Dexycu has been studied in one completed Phase 3 clinical trial, identified as NCT06429306. This randomized, double-blind, placebo-controlled trial enrolled 285 participants with inflammation and cataract in China, evaluating the drug's effect on intraocular inflammation.
No alternative names have been reported for Dexycu. It is a distinct investigational drug candidate developed by cbdMD, Inc. for the treatment of intraocular inflammation, and no other names or aliases are associated with it in clinical development.