Pykus Therapeutics Reports Positive Trial Results for Retinal Sealant PYK-2101

On May 2, 2025, Pykus Therapeutics, based in Cambridge, Massachusetts, unveiled promising results from an ongoing pilot study at the Eyecelerator meeting in Park City. This study focuses on PYK-2101, a pioneering retinal hydrogel sealant designed for patients undergoing surgery for retinal detachment.

The preliminary data suggests that PYK-2101 not only meets but surpasses the FDA's target rates for ocular endotamponades, which are agents used to facilitate retinal attachment. The product demonstrated significant potential for enabling rapid visual recovery post-surgery without any serious safety concerns. Dr. James (Tony) Stefater, President and co-founder of Pykus, shared these findings during the event.

PYK-2101 stands out because it promises to transform the post-operative experience for patients. According to Dean Eliott, MD, a prominent figure in ophthalmology at Harvard Medical School, the current procedures require patients to maintain a prone, "face-down" position for nearly 24 hours a day. This not only restricts their movement and travel but also leads to poor vision for several weeks following surgery. Eliott expressed optimism about PYK-2101, highlighting its potential to significantly enhance the recovery process and eliminate the need for restrictive postures, thereby improving the overall patient experience.

The study, known as PYK-2101-RD001, is a prospective, multicenter, open-label pilot trial involving 11 patients with retinal detachment undergoing pars plana vitrectomy. The primary goal is to assess the safety and tolerability of PYK-2101 during the initial 16 weeks post-surgery. Key outcomes being measured include the anatomical attachment rate, speed of visual acuity recovery, the progression of cataracts, changes in intraocular pressure, and any adverse events. The trial is being conducted in leading vitreoretinal clinics across Australia.

So far, the results have been promising. PYK-2101 has achieved a retinal attachment rate of 91% in the per protocol population and 73% in the intent-to-treat population, both exceeding the FDA's benchmark of 72%. Importantly, no serious adverse events or effects on intraocular pressure have been observed, indicating PYK-2101's safety profile.

PYK-2101 is a patented, first-in-class biodegradable hydrogel sealant. The Company is focusing initially on its application for retinal detachment treatment. Unlike traditional methods that employ endotamponade agents like intraocular gases or silicone oil, PYK-2101 seals retinal breaks directly without obscuring vision, facilitating faster visual recovery and eliminating the need for patients to remain "face-down" after surgery. This approach is expected to significantly improve surgical outcomes and enhance the patient's post-operative experience.

Retinal detachment surgery, often involving vitrectomy, is a common procedure, with nearly two million surgeries performed globally each year. However, the traditional treatment approach imposes significant burdens on patients, such as extended visual recovery times and a high rate of surgical failure, often necessitating repeat surgeries and sometimes resulting in permanent vision loss.

Pykus Therapeutics is a clinical-stage medical technology company dedicated to advancing treatments for retinal and other eye-related conditions. Utilizing technology developed and licensed from Mass Eye and Ear at Harvard Medical School, Pykus aims to revolutionize surgical outcomes and elevate patient care standards. The organization is eagerly anticipating further results from the ongoing trial, expected to be available in the coming months.