NEW YORK – Swiss biotech Oculis on Monday said it would discuss with the US Food and Drug Administration plans to move its dry eye disease (DED) investigational treatment licaminlimab into later-stage studies, particularly in a biomarker-selected subpopulation.
In the 122-patient Phase IIb RELIEF trial, the anti-TNFα biologic eye drop had improved safety and efficacy compared to placebo. In a subset of 23 DED patients with a specific TNFR1-related genotype, licaminlimab's efficacy was even more pronounced.
In the overall study population, licaminlimab improved multiple signs of DED that the FDA accepts as measures of efficacy in clinical trials, Oculis said. These included improvements in fluorescein staining in the total cornea and in the inferior corneal, central corneal, and nasal conjunctival regions, as well as better scores in the Schirmer's test, which measures the eye's ability to produce tears.
In the subset of patients with the TNFR1 genetic biomarker, those on licaminlimab had even better outcomes on those fluorescein staining measures and on additional ones. Patients also fared better on the Schirmer's test and had less conjunctival redness. According to the company, researchers observed rapid treatment effects on corneal inflammation in patients with the TNFR1 biomarker as early as day 15 following treatment, and the outcomes difference compared to placebo was statistically significant at patients' final efficacy visit on day 43.
"We are pleased that we achieved all of our objectives for the trial, and extremely encouraged to see licaminlimab's profound results with a precision medicine approach, which has the potential to transform the way we develop drugs and treat patients in ophthalmology," Oculis CEO Riad Sherif said in a statement. "With this and prior positive results on signs and symptoms, we look forward to discussing these encouraging data with the FDA and advancing this program into Phase III."
Oculis said it intends to have an end-of-Phase II meeting with the FDA to discuss the registrational path for licaminlimab in DED patients and finalize a Phase III development plan for the agent.
According to Eric Donnenfeld, a clinical professor of ophthalmology at New York University and chair of Oculis' cornea scientific advisory board, licaminlimab may be the first DED medication to show a treatment benefit in a biomarker-defined patient population. "The precision medicine approach with licaminlimab could be a groundbreaking paradigm shift in ophthalmology and the treatment of DED," Donnenfeld said in a statement. "The current approach of 'trial and error’ and our inability to predict response for this highly heterogenous population leads to a low level of patient satisfaction."