Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-444 · 2 trials · 2 indications
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5- point scale (0=none of the time to 4=all of the time), with higher scores representing worse symptoms. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no symptom to 100=worst symptom). A negative number change from baseline represents an improvement.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.
| Arm | Type | Description |
|---|---|---|
| ABBV-444 | EXPERIMENTAL | Participant will receive ABBV-444 as needed but at least twice a day for 90 days. |
| REFRESH OPTIVE UD | ACTIVE_COMPARATOR | Participant will receive REFRESH PLUS as needed but at least twice a day for 90 days. (Refresh Plus is the run-in medication for 7-10 days before study treatment assignment) |
| Name | Type | Description |
|---|---|---|
| ABBV-444 | DRUG | Topical eye drop |
| REFRESH OPTIVE UD | DRUG | Topical eye drop |
Inclusion Criteria: * Ocular Surface Disease Index (OSDI) score of ≥ 28 and ≤ 65 (based upon a 0 to 100 scale) at Screening. (Day -7) and an OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Baseline (Day 1). * Three consecutive tear breakup time (TBUT) tests of ≤ 10 seconds in at least ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 1 | N/A | Undisclosed |
| Harrow, Inc. | HROW | 1 | - | Undisclosed |
ABBV-444 is an investigational small molecule being developed for Dry Eye Disease and Dry Eye Syndrome. It is formulated as eye drops and is intended to provide symptom relief and improve tolerability in adult patients with these conditions. The drug is currently in Phase 3 clinical development.
ABBV-444 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with dry eye conditions.
ABBV-444 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been conducted or are ongoing to assess its effects in adult patients with Dry Eye Disease and Dry Eye Syndrome.
ABBV-444 has been studied in two Phase 3 trials. NCT05878067, a completed study with 40 participants, assessed symptom relief and tolerability in Dry Eye Syndrome. NCT07284381, an active but not recruiting trial with 261 participants, compares ABBV-444 to Refresh Optive Unit Dose in Dry Eye Disease.
ABBV-444 is a small molecule formulated as an artificial tear. It is designed to relieve symptoms of Dry Eye Disease and Dry Eye Syndrome by lubricating the ocular surface. Its mechanism involves supplementing natural tears to reduce discomfort associated with dry eye conditions.