PST-611 / PulseSight Therapeutics - LARVOL DELTA

A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Eyevensys | Not yet recruiting ➔ Completed | N=12 ➔ 8 | Trial primary completion date: Dec 2025 ➔ Apr 2026

Enrollment change • Trial completion • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

An Open-label Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Geographic Atrophy (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Eyevensys

New P2 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Positive Results from PulseSight’s Phase I Clinical Trial of PST-611 in Dry AMD/Geographic Atrophy Presented at ARVO 2026 (The Manila Times) - "PST-611-CT1 met the primary and secondary objectives, with PST-611 demonstrating excellent safety and tolerability at both dose levels. Most reported ocular adverse events were mild, with two assessed as moderate...PulseSight has submitted a Clinical Trial Authorization (CTA) application to the French regulatory authority, Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), of a repeat dose, 52-week, Phase 2a trial (PST-611-CT2) designed to assess the safety and explore the efficacy of three administrations of PST-611 in up to 20 patients, in 3 clinical trial sites. Subject to CTA approval, the trial is anticipated to begin in H2 2026, with results expected in 2028."

New P2a trial • P1 data • Age-related Macular Degeneration

A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Eyevensys

Trial initiation date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Transferrin in geographic atrophy patients using non-viral ocular gene therapy : Results from PST-611-CT1, a First-in-Human trial. (ARVO 2026) - P1 | "These results support continued development of PST-611 in GA and the conduct of aPhase 2 clinical trial with the highest safe and tolerated dose identified in PST-611-CT1. Layman Abstract:Report of the first human clinical trial evaluating the safety of electrotransfer of plasmid in the ciliary muscle to produce transferrin in GA patients"

Clinical • First-in-human • Gene therapy • P1 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders

A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Eyevensys

New P1 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

PulseSight Therapeutics Announces First Close of its Series A Financing to Fund Clinical Development of PST-611 in dry AMD (GlobeNewswire) - "PulseSight Therapeutics...today announces the first close of its Series A financing with existing investor Pureos BioVentures committing new funds to support the Phase I study of PST-611 and enable preparation for a Phase IIa clinical trial....PST-611 is a first in class non-viral vectorized therapy for the treatment of dry age-related macular degeneration (AMD)/geographic atrophy (GA)...The planned PST-611-CT1 clinical trial aims at primarily confirming the favorable safety profile of PST-611 administration and is expected to start Q2 2025, subject to the regulatory greenlight, with readout anticipated end 2025/early 2026....The Series A financing remains open to new investors, to provide funds to support PST-611 Phase IIa clinical trial preparation and implementation, as well as the development of PulseSight’s wider portfolio of non-viral vectorized therapies including PST-809, a potential first-in-class therapy for wet AMD that comprises a dual-gene plasmid encoding..."

Financing • New P2a trial • P2a data • Regulatory • Dry Age-related Macular Degeneration • Ophthalmology

[VIRTUAL] Human transferrin protects retinal ganglion cells in a rat model of ocular hypertension (ARVO 2021) - "These results demonstrate the ability of Tf to protect RGCs exposed to elevated IOP, suggesting that iron chelation could benefit glaucoma patients. These proof-of-concept findings and previous data demonstrating sustained intraocular production of Tf following non-viral gene transfer strongly support the evaluation of EYS611 for long-term and effective neuroprotection in glaucoma."

Preclinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Glaucoma • Inherited Retinal Dystrophy • Macular Degeneration • Ocular Inflammation • Ophthalmology • Optic Neuritis • Retinal Disorders • Retinitis Pigmentosa • RBPMS