Oculis’s PREDICT-1 registrational trial for licaminlimab is on track for a topline readout around year-end, and the company is using two sessions at the American Academy of Ophthalmology’s 2026 meeting to put that data context in front of the specialists who would prescribe it. The timing matters because PREDICT-1 is not a standard dry eye trial: it enrolls only patients who carry a specific TNFR1-related genotype, making it one of the few registrational programs in ophthalmology built entirely around a genetic patient-selection rule.
That design choice traces back to the Phase 2b RELIEF trial, where licaminlimab showed broader effects on dry eye signs across the full population but markedly stronger results in the TNFR1 biomarker subgroup. Rather than pursue an all-comers label, Oculis structured PREDICT-1 to test whether that precision-medicine bet holds at registration scale. The drug works as a topical anti-TNFα eye drop with both anti-inflammatory and anti-apoptotic activity, a dual mechanism that distinguishes it from the calcineurin inhibitors and lymphocyte function blockers that already populate dry eye prescribing, including Restasis, Xiidra, and Cequa.
The AAO presence splits across two formats. Oculis will present at Eyecelerator, a pitch-style innovation forum running alongside the main meeting, and will partner with Neuro-Ophthalmology Subspecialty Day, which broadens the conversation beyond standard dry eye into the neurologically adjacent patient populations where TNFR1 signaling is also implicated. Reaching neuro-ophthalmologists before a readout is deliberate: if PREDICT-1 data hold, this subspecialty represents a prescriber base that the existing approved agents were not specifically designed for.
The whole program stands or falls on whether the genotype-restricted design produces a clean registration outcome. If PREDICT-1 hits its primary endpoint in the TNFR1-positive population, Oculis has a differentiated label argument; if the signal narrows further or misses, the precision bet collapses entirely. The year-end readout is the number to watch.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
