PulseSight presented Phase 1 data for PST-611 at ARVO 2026, reporting that the single ascending dose, first-in-human PST-611-CT1 trial enrolled six patients across two dose levels with 16-week follow-up and was conducted in Paris and Grenoble.
The trial met its primary and secondary objectives, with the company reporting excellent safety and tolerability at both dose levels, mostly mild ocular adverse events, no intraocular inflammation, no treatment-emergent serious adverse events or suspected unexpected serious adverse reactions, and stable best corrected visual acuity over follow-up.
Although not designed to assess efficacy, the company reported encouraging early functional and anatomical signals, including spontaneous patient-reported vision improvements and associated inflections in geographic atrophy lesion growth, with one signal persisting beyond the trial follow-up.
PulseSight has submitted a Clinical Trial Authorization to the French regulator ANSM for a repeat-dose phase 2a trial of three high-dose administrations over 52 weeks in up to 20 patients at three sites, with the company stating the trial is anticipated to begin in the second half of 2026 pending approval and to yield results in 2028.
The company describes PST-611 as a transferrin-encoding gene therapy intended to address iron dysregulation implicated in dry AMD, and cites preclinical data showing photoreceptor and retinal pigment epithelium protection and preservation of visual function; the company also referenced research estimating the broader AMD market could reach $27.5 billion by 2031.
