Key Takeaways

  • Oculis has randomized the first patient in PREDICT-1, the first genotype-based registrational trial in dry eye disease
  • The trial is evaluating licaminlimab in patients with a specific TNFR1 genetic profile linked to enhanced treatment response
  • The precision medicine study builds on phase 2 data showing greater improvements in dry eye signs and symptoms among TNFR1 genotype-positive patients

Oculis announced the randomization of the first patient in its pivotal PREDICT-1 (Personalized dRy Eye Disease Investigational Clinical Trial) study evaluating licaminlimab in dry eye disease (DED).

The milestone marks the launch of what Oculis describes as the first genotype-based registrational trial in DED. PREDICT-1 is designed to assess the efficacy and safety of licaminlimab, a topical anti-TNFα biologic, in patients carrying a specific TNFR1 genotype associated with enhanced treatment response. The randomized, multicenter, double-masked, vehicle-controlled study plans to enroll approximately 160 patients, with roughly two-thirds selected for the targeted TNFR1 genetic profile.

The trial’s primary endpoint is the change from baseline to Day 29 in global ocular discomfort severity among patients with the specified genotype. The same measure will also be assessed in the overall study population as a key secondary endpoint.

"Randomization of the first patient in PREDICT-1 marks an important milestone for licaminlimab and for the advancement of a genotype-based, precision medicine approach in dry eye disease, a highly unsatisfied market," said Riad Sherif, MD, Chief Executive Officer of Oculis. "Supported by a well-validated anti-TNFα mechanism of action, this targeted trial is designed to maximize clinical efficiency by focusing on patients most likely to respond."

According to Oculis, to improve trial efficiency and patient selection, PREDICT-1 incorporates a genotype screening phase prior to enrollment. Potential participants are assessed for both TNFR1 genotype status and symptom severity, measured using a global ocular discomfort severity score of at least 60 before and after an artificial tear run-in period.

The study builds on phase 2 findings showing that licaminlimab generated stronger clinical responses in patients carrying a specific TNFR1 genotype, producing meaningful improvements in both DED signs and symptoms. Researchers believe genetic variation within the TNF/TNFR1 inflammatory pathway may explain differences in patient responses and could represent a critical driver of ocular surface inflammation in dry eye disease.

If confirmed in PREDICT-1, these findings could support the first precision medicine treatment paradigm in ophthalmology, Oculis stated. 

"We believe Licaminlimab, if approved, has the potential to reshape the treatment paradigm for this multifactorial disease," Dr. Sherif said. "By pioneering an innovative development strategy, our objective is to deliver a precision medicine approach that addresses a major unmet need for the millions of underserved patients currently constrained by a trial-and-error method."