PulseSight Therapeutics Completes Phase I Trial for Novel AMD Treatment, PST-611
A promising new gene therapy, PST-611, developed by PulseSight Therapeutics, has completed its Phase I clinical trial, offering a potential breakthrough in the treatment of dry Age-related Macular Degeneration (AMD) and Geographic Atrophy (GA). Data from the trial will be presented at the 2026 ARVO Annual Meeting, scheduled for May 3-7.
Addressing a Critical Unmet Need in AMD Treatment
Dry AMD, affecting an estimated 200 million people globally, is the leading cause of central vision loss in the elderly. The advanced form, Geographic Atrophy, represents a significant challenge for clinicians due to the lack of effective, well-tolerated treatments that can halt disease progression. PST-611 aims to address this critical unmet need with a first-in-class approach.
How PST-611 Works: Restoring Iron Homeostasis
PST-611 is a vectorized gene therapy designed to express transferrin, a naturally occurring protein responsible for regulating iron transport within the body. In dry AMD, iron homeostasis is disrupted, leading to an accumulation of free iron that triggers damaging effects like inflammation, oxidative stress, and ultimately, the death of retinal cells – a process known as ferroptosis. According to company data, PST-611 has demonstrated the ability to protect photoreceptors and retinal pigment epithelium (RPE) cells, while also preserving visual function in preclinical animal models.
Phase I Trial Results and Next Steps
The Phase I trial assessed the safety and tolerability of PST-611 in six patients with dry AMD/GA, treated across two dose levels in successive cohorts. A company release confirmed that the trial was completed as planned. “This trial marks the first step of PST-611 clinical development and provides the foundation to build upon for the Phase IIa trial we are already preparing,” stated a senior official at PulseSight.
Innovative Delivery Technology
The therapy utilizes a minimally-invasive delivery technology, employing electro-transfection to deliver DNA plasmids encoding therapeutic proteins directly into the ciliary muscle of the eye. This approach allows the ciliary muscle cells to function as “biofactories,” producing and distributing therapeutic proteins to the retina, offering a safe and potentially long-lasting treatment option. “Having pioneered the development of the electro-transfection technology… I am very enthusiastic about PST-611,” said a leading investigator in the study, Professor Francine Behar-Cohen, MD, PhD, of Cochin Hospital in Paris.
The Phase I study was conducted in Paris and Grenoble, led by Professor Behar-Cohen and Professor Christophe Chiquet, MD, PhD, at CHU Grenoble Alpes.
Market Potential and Future Outlook
The market for AMD treatments is substantial and growing, projected to reach $27.5 billion by 2031. PST-611, with its potential for infrequent re-treatment – estimated every four to six months – could represent a significant advancement in the field. Phase 1 study results are anticipated in the first quarter of 2026.
About PulseSight Therapeutics
PulseSight Therapeutics is a Paris-based, clinical-stage biotech company focused on developing non-viral vectorized therapies for retinal diseases, including both wet AMD and GA. The company’s technology platform has already demonstrated clinical validation for safety and sustained activity. PulseSight’s investors include Pureos Bioventures, ND Capital, and Korea Investment Partners (KIP).
For more information, visit www.PulseSightTherapeutics.com.
Watch a video detailing the company’s technology here: www.PulseSightTherapeutics.com.
Follow PulseSight Therapeutics on LinkedIn: https://www.linkedin.com/company/pulsesight-therapeutics/.
