AbbVie Targets Dry Eye Market With New ABBV-444 Trial: What Investors Should Watch

Abbvie (ABBV) announced an update on their ongoing clinical study.

Study Overview
AbbVie is running a phase 3 trial called “A Multicenter, Double-masked, Randomized Study to Compare the Efficacy and Safety of the ABBV-444 Tear Formulation With REFRESH OPTIVE® Unit Dose in Patients With Dry Eye Disease.” The study aims to see if AbbVie’s new artificial tear, ABBV-444, works as well as or better than a leading over-the-counter product, while remaining safe over 90 days. For investors, this is notable because it targets a large and growing dry eye market where reliable, branded options can support recurring revenue.

Intervention/Treatment
The trial is testing ABBV-444, a new eye drop designed to relieve symptoms of dry eye disease by improving lubrication on the eye surface. It is compared directly with REFRESH OPTIVE® Unit Dose, a well-known artificial tear already on the market. Both products are used as eye drops several times a day, with the goal of reducing discomfort, dryness, and irritation.

Study Design
This is an interventional study where about 250 adults with dry eye disease are randomly assigned to one of two groups. One group receives ABBV-444 and the other receives REFRESH OPTIVE® UD. The study uses a parallel design, meaning each participant only uses one product for the full 90 days. It is “double-masked,” so neither the patients nor the study doctors know which product is being used. The main goal is to test how well the products treat dry eye symptoms and how safe they are.

Study Timeline
The study was first submitted on December 8, 2025, marking the formal start of the trial process and signaling AbbVie’s commitment to push ABBV-444 through late-stage testing. The trial is currently listed as recruiting, with treatment lasting 90 days per participant. While primary and final completion dates are not yet posted, the latest update on December 22, 2025, confirms the study is active and progressing. These updates help investors track development risk and timeline to possible commercialization.

Market Implications
If ABBV-444 shows better or even comparable results to REFRESH OPTIVE® UD, AbbVie could secure a new position in the large and stable dry eye segment, which is currently dominated by companies like Alcon and Bausch + Lomb. Positive data could support incremental revenue, strengthen AbbVie’s eye-care portfolio, and provide a non-patent-expiring, cash-generating product that helps offset pressure from larger franchises. For ABBV shares, any clear signal of strong efficacy, safety, and patient adoption could improve sentiment, especially among investors looking for diversification beyond immunology and oncology assets. Competitors may face mild pricing pressure if AbbVie chooses to market ABBV-444 aggressively, but the overall category growth should help soften any share shifts. For now, the trial is an early but favorable sign that AbbVie is investing in broader, consumer-facing eye-care offerings.

The study remains ongoing and updated, with further details available on the ClinicalTrials.gov portal under identifier NCT07284381.

To learn more about ABBV’s potential, visit the Abbvie drug pipeline page.