Precision Medicine for Dry Eye: PREDICT-1 Finishes Randomization

Dry eye treatments often feel like trial and error. PREDICT-1, described as the first genotype-guided registrational dry-eye trial, has now finished randomizing patients and may show whether a genetic marker can identify who responds best to a topical anti-TNFα drop called licaminlimab.

What was announced

Oculis Holding AG completed randomization of 176 patients in PREDICT-1 (NCT07548632), above its original target of about 160. About two-thirds carry a TNFR1 genetic variant previously linked to a stronger response in phase 2 work. Topline results are expected around year-end 2026. Licaminlimab remains investigational and is not approved for commercial use.

How the trial is built

• Randomized, multicenter, double-masked, and vehicle-controlled
• Primary end point: change in global ocular discomfort severity at day 29 among genotype-positive patients
• Key secondary: the same discomfort measure in the overall population, plus safety
• A screening phase identifies genotype before enrollment

Company estimates suggest 13% to 19% of people with moderate-to-severe dry eye in the U.S.—roughly 1.3 to 1.9 million people—may carry the target variant, identifiable with a simple noninvasive genetic test if the approach is validated.

Why clinicians are watching

Anat Galor, MD, MSPH, of Bascom Palmer, noted that dry eye is highly heterogeneous and that mismatched therapies drive early discontinuation. Earlier phase 2 work reported symptom improvement with licaminlimab versus vehicle by day 29, with onset as early as day 14 in one study, and a genotype-enriched subgroup signal in the RELIEF program. PREDICT-1 is the confirmatory test of that strategy.

What Los Angeles patients should do now

• Do not wait for future genetics to start proven basics: lid hygiene, environment changes, and prescribed lubricants or anti-inflammatories.
• Ask which dry-eye subtype you have before adding another bottle.
• If a genetic test is offered someday, ask how results would change the plan.

Keep expectations realistic

Even if genotype-guided therapy eventually reaches the market, most people with dry eye will still need foundational care. Inflammation, incomplete blinking at screens, rosacea-related lid disease, and medication side effects will not disappear because of a single biomarker. Think of PREDICT-1 as a step toward smarter matching, not a reason to pause today’s treatment.

Khanna Vision Institute treats dry eye within comprehensive ophthalmology and refers complex inflammatory surface disease when needed. Related reading: piineye.com.

Source: First genotype-guided dry eye trial, PREDICT-1, completes randomization (Optometry Times, 10/30/2026). This article is an educational summary written by Khanna Vision Institute and is not a substitute for medical advice.