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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 ...
Top 3 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-319 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
ABBV-444 is an investigational small molecule eye drop being developed by AbbVie Inc. as an artificial tear formulation for dry eye disease and dry eye syndrome. It is designed to be instilled into the eye to relieve dry eye symptoms, and it is currently in Phase 3 clinical development.
ABBV-444 is being studied for the treatment of dry eye disease and dry eye syndrome in adults 18 years and older. It is formulated as an artificial tear drop intended to relieve dry eye symptoms and to be well tolerated when applied to the eye.
ABBV-444 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the artificial tear formulation in adult participants with dry eye disease and dry eye syndrome.
ABBV-444 is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. Two Phase 3 trials of ABBV-444 have been completed, and no trials of the drug are currently listed as active.
ABBV-444 has been evaluated in two completed Phase 3 trials. NCT07284381 compared ABBV-444 with Refresh Optive Unit Dose in 261 adults with dry eye disease in the United States. NCT05878067 assessed symptom relief and tolerability of ABBV-444 drops in 40 adults with dry eye syndrome.
The ABBV-444 Phase 3 program enrolled adults 18 years and older of all sexes. NCT07284381 was a randomized, double-blind, active-controlled study of 261 participants with dry eye disease, and NCT05878067 evaluated symptom relief and product tolerability in 40 participants with dry eye syndrome.