Oculis Holding AG said Oct. 19 it completed randomization in a trial with 176 patients enrolled, testing whether a genetic marker can guide dry-eye treatment.
About two-thirds of those enrolled in PREDICT-1 carry the specified TNFR1 genotype. The trial compares Oculis’ experimental eye drop Licaminlimab with vehicle eye drops. Its main measure is the change in global ocular discomfort severity from baseline to Day 29 among patients with that genotype. Investigators will also examine the change across all participants.
Oculis is pursuing the genotype-based approach because responses to dry-eye treatment vary. In an earlier published Phase 2 study, patients receiving Licaminlimab reported greater improvement in ocular discomfort at Day 29 than those receiving vehicle drops. Oculis later reported results favoring Licaminlimab on measures of dry-eye signs among 23 patients with the targeted genotype in its 122-person RELIEF trial. Those signs differ from the patient-reported discomfort that is PREDICT-1’s main measure.
The evidence for selecting patients by genotype carries a qualification. A published analysis of genetic findings from an earlier trial was retracted at its authors’ request. The journal said the authors considered the data exploratory and wanted stronger evidence before drawing conclusions.
Licaminlimab is not approved for commercial use in any country. Oculis expects to report PREDICT-1 topline results around year-end 2026.
