Oculis enrolls first patient in licaminlimab PREDICT-1 DED trial

Genotype-guided treatment

According to a new announcement, Oculis has randomized the first patient in the Personalized dRy Eye Disease Investigational Clinical Trial (PREDICT-1), a registrational trial evaluating licaminlimab, a topical anti-TNFα biologic eye drop, in patients with dry eye disease (DED) carrying a specific TNFR1 genotype.¹ PREDICT-1 is described by Oculis as the first genotype-based registrational trial in DED, designed to deliver what the company characterizes as a precision medicine approach to a condition with a high rate of treatment failure and discontinuation.¹ Licaminlimab is investigational and has not received regulatory approval in any country.

For optometrists managing DED longitudinally, the unmet need is well-documented. Approximately 87% of patients do not feel their chronic DED is well-managed on current therapies, and discontinuation rates within the first 6 months of prescription treatment exceed 85% to 90%.¹ A precision medicine approach targeting a defined genetic subpopulation represents a meaningful departure from the current trial-and-error prescribing model ODs routinely encounter in clinical practice.

"The advancement of licaminlimab represents meaningful progress in dry eye disease research, particularly in light of the substantial unmet need among patients and clinicians, many of whom remain dissatisfied and frustrated with the current trial-and-error treatment paradigm," said Anat Galor, MD, MSPH, professor of ophthalmology at Bascom Palmer Eye Institute, Miami. "Results from prior phase 2 studies demonstrated clinically relevant improvements in both signs and symptoms, with a more pronounced and differentiated response observed in patients carrying a specific TNFR1 genotype."

PREDICT-1 trial design

PREDICT-1 is a randomized, multicenter, double-masked, vehicle-controlled study planning to enroll approximately 160 patients, of whom roughly two-thirds will carry the specified TNFR1 genotype.¹ The primary end point is the change from baseline to Day 29 in the global ocular discomfort severity score in patients with the specified TNFR1 genotype. The same measure will be evaluated in the overall study population as a key secondary endpoint.¹

The trial incorporates a screening phase to ensure appropriate patient selection. Genotype status is assessed prior to an artificial tear run-in phase, and ocular discomfort severity of 60 or greater on the global ocular discomfort severity score must be confirmed both before and after the run-in phase for enrollment.¹ Approximately 70% of clinical sites are already activated, with patients currently in the run-in phase, according to Oculis.¹

Licaminlimab is formulated as a single-chain antibody fragment (scFv) topical eye drop targeting TNFα, a key mediator of ocular surface inflammation.¹ TNFR1 is a primary receptor through which TNFα drives both inflammation and apoptosis at the ocular surface. Phase 2 data identified a variant in the TNFR1 gene associated with a five- to seven-fold more pronounced treatment response to licaminlimab compared with the overall study population, providing the mechanistic rationale for the genotype-stratified design of PREDICT-1.¹

Phase 2b Findings

The phase 2b RELIEF trial (NCT05896670) enrolled 122 patients randomized 1:1 to licaminlimab or vehicle for a 6-week treatment period with a 2-week follow-up; 23 patients carried a specific TNFR1-related genotype.² Across the full study population, licaminlimab demonstrated a treatment effect on multiple DED sign endpoints, including fluorescein staining in the total cornea, inferior corneal, central corneal, and nasal conjunctival regions, as well as the Schirmer's test.²

In the TNFR1 genotype subpopulation, the treatment effect was more pronounced—extending to additional endpoints including total conjunctival and total ocular surface regions, conjunctival redness, and corneal fluorescein staining.² A rapid reduction in corneal inflammation was observed in TNFR1 biomarker patients as early as day 15, with the effect reaching statistical significance at day 43, measured by the difference in mean change from baseline versus vehicle for inferior corneal fluorescein staining score: -0.59 (95% CI: -1.165, -0.017).² Licaminlimab was well tolerated in RELIEF, with mild and transient ocular adverse events comparable to the vehicle group and no serious ocular adverse events reported; comfort was described as similar to artificial tears.²

"The first patient randomized in PREDICT-1 marks an important milestone for licaminlimab and for the advancement of a genotype-based, precision medicine approach in dry eye disease," said Riad Sherif, MD, chief executive officer of Oculis. "This targeted trial is designed to maximize clinical efficiency by focusing on patients most likely to respond."

For optometrists, licaminlimab—if approved—would represent a novel mechanism of action in the DED prescribing landscape, distinct from cyclosporine- and lifitegrast-based anti-inflammatory options currently available.³ PREDICT-1 data will determine whether a genotype-screening step prior to prescribing is clinically and practically feasible in OD practice. ODs managing patients with refractory DED or recurrent treatment failures may find the TNFR1 biomarker framework relevant as the evidence base develops.

References:

1. Oculis Holding AG. Oculis Announces First Patient Randomized in PREDICT-1 Registrational Trial of Licaminlimab, Advancing Precision Medicine in Dry Eye Disease. GlobeNewswire News Room. Published June 9, 2026. Accessed June 11, 2026. https://www.globenewswire.com/news-release/2026/06/09/3308583/0/en/oculis-announces-first-patient-randomized-in-predict-1-registrational-trial-of-licaminlimab-advancing-precision-medicine-in-dry-eye-disease.html

2. Oculis Holding AG. Oculis announces positive topline results of phase 2b RELIEF trial with licaminlimab. Published June 10, 2024. Accessed June 10, 2026. https://investors.oculis.com/news-releases/news-release-details/oculis-announces-positive-topline-results-phase-2b-relief-1
   Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II diagnostic methodology report. Ocul Surf. 2017;15(3):539-574. doi:10.1016/j.jtos.2017.05.001

3. Wolffsohn JS, Arita R, Chalmers R, et al. TFOS DEWS II diagnostic methodology report. Ocul Surf. 2017;15(3):539-574. doi:10.1016/j.jtos.2017.05.001