Oculis Holding AG has completed randomization in PREDICT-1 (Personalized dRy Eye Disease Investigational Clinical Trial), the registrational study evaluating licaminlimab, a topical anti-TNFα eye drop, in patients with dry eye disease (DED) who carry a specific TNFR1 genotype (NCT07548632).¹ The Zug, Switzerland–based company said it expects to report topline results around year-end 2026.
The milestone moves what Oculis describes as the first genotype-guided registrational trial in DED a step closer to a readout that will test whether a genetic biomarker can reliably identify the patients most likely to respond to an anti-inflammatory therapy.
Frequently Asked Questions
What is PREDICT-1?
PREDICT-1 is a registrational trial evaluating licaminlimab, a topical anti-TNFα eye drop from Oculis, in patients with dry eye disease (DED) who carry a specific TNFR1 genotype. It is the first genotype-guided registrational trial in DED.1
Where does the trial stand?
Oculis has completed randomization of 176 patients, exceeding its original target of about 160. Topline results are expected around year-end 2026, according to Riad Sherif, MD, CEO of Oculis.1
Why does genotype matter?
In earlier phase 2 work, patients carrying a TNFR1 variant showed a stronger response to licaminlimab. About two-thirds of PREDICT-1 participants carry this variant, which a simple, noninvasive genetic test can identify.1,5
What is the trial measuring?
The primary end point is the change from baseline at day 29 in the global ocular discomfort severity score among genotype-positive patients. The same measure across the overall study population is a key secondary end point, and the trial also evaluates safety.1
How many patients could this affect?
Oculis estimates that 13% to 19% of patients with moderate-to-severe DED in the US carry the target variant. That is roughly 1.3 million to 1.9 million people.1
What could this mean for clinical practice?
If the trial succeeds, genetic testing could help eye care providers identify likely responders before starting treatment. That could shorten the trial-and-error process that leads many patients with DED to stop therapy early. It may also raise questions about how testing fits into clinic workflow.1
Enrollment closes ahead of plan
PREDICT-1 randomized its first patient in June 2026.² At the time, Oculis said it planned to enroll approximately 160 patients, roughly two-thirds of whom would carry the target TNFR1 variant.² By early August, all planned sites had been activated and more than 45% of patients had been randomized, according to the company's second-quarter update.³ The final tally of 176 patients, two-thirds of them genotype-positive, exceeds that original target.¹ Optometry Times covered the trial's launch in June.⁴
"Completing randomization in such a timeframe with a new modality demonstrates that genotype-driven development is crucial and precision medicine is urgently needed in DED," said Riad Sherif, MD, CEO of Oculis. "PREDICT-1 is an important operational milestone as we track toward topline results around year-end 2026."¹
Trial design
PREDICT-1 is a randomized, multicenter, double-masked, vehicle-controlled study. Its primary endpoint is the change from baseline at day 29 in the global ocular discomfort severity score among patients carrying the specified TNFR1 genotype. The same measure will be assessed across the overall study population as a key secondary endpoint, and the trial will also evaluate safety.¹ To improve efficiency, the study incorporated a genotype screening phase before enrollment.²
The design places symptom relief, rather than ocular surface signs, at the center of the registrational question. That choice is not without risk: Oculis has acknowledged that measurements of dry eye symptoms are inherently subjective, framing genotype enrichment as a way to select the patients most likely to show a measurable benefit.³
Building on phase 2 signals
The rationale for PREDICT-1 rests on earlier phase 2 work. In a prior phase 2 trial focused on DED symptoms, patients treated with licaminlimab experienced a statistically significant reduction in ocular discomfort compared with vehicle at Day 29, with onset of action observed as early as Day 14.1,5
The phase 2b RELIEF trial, reported in 2024, evaluated licaminlimab on the signs of DED and included a prespecified subpopulation of 23 patients carrying the TNFR1-related genotype.⁶ As Ophthalmology Times, a sister publication of Optometry Times, reported at the time, the company observed a treatment effect favoring licaminlimab in that subgroup, positioning the genetic marker as a potential predictor of response.⁶ Across its phase 2 program, Oculis reports that the drug has been well tolerated.¹
Licaminlimab is a single-chain antibody fragment (scFv) developed specifically for ocular inflammatory disease. TNFR1 mediates TNFα-driven inflammation and apoptosis, and published research suggests that genetic variation in the TNF/TNFR1 pathway may help explain why inflammatory responses—including those on the ocular surface—differ between patients.1,7 According to Oculis, a simple, noninvasive genetic test can identify carriers of the relevant variant.¹
The case for precision medicine in DED
The program arrives as thinking about DED continues to evolve. Ophthalmology Times published a Q&A during Dry Eye Awareness Month with Esen K. Akpek, MD, of the Wilmer Eye Institute at Johns Hopkins. In the Q&A, Akpek discussed how the TFOS DEWS III report has moved classification away from the aqueous-deficient vs evaporative dichotomy toward identifying root causes.⁸ Akpek pointed to reliable biomarkers and patient-centered outcome measures as the field's greatest unmet need on the path to true precision medicine, and the article highlighted anti-TNFα biologics among the emerging therapies pushing care toward mechanism-based treatment.⁸
