Pykus Therapeutics announced the completion of enrollment in its Australian pilot study evaluating PYK-2101, a novel focal hydrogel retinal sealant designed to revolutionize treatment for patients with retinal detachment. The Cambridge, Massachusetts-based company aims to provide interim results from the trial in the second quarter of 2025.
The prospective, multicenter, open-label pilot trial (PYK-2101-RD001) includes 11 patients with retinal detachment undergoing pars plana vitrectomy. Researchers will evaluate the safety and tolerability of PYK-2101 within the first 16 weeks following surgery, with outcome measures including anatomical attachment rate, visual acuity recovery speed, cataract progression, intraocular pressure changes, and adverse events.
Potential Paradigm Shift in Vitreoretinal Surgery
"Should PYK-2101 prove successful in clinical trials, it will represent a paradigm shift in vitreoretinal surgery," said John Pollack, MD, FASRS, past-President of the American Society of Retina Specialists (ASRS) and a vitreoretinal specialist with Illinois Retina Associates and Rush University Medical Center. "Eliminating the need for intraocular gas would be transformative for patients undergoing vitrectomy, addressing a significant source of patient anxiety."
The current standard of care for retinal detachment surgery involves filling the eye with endotamponade agents such as intraocular gases or silicone oil. This approach requires patients to maintain face-down positioning for up to 23 hours daily, causes impaired vision, and restricts air travel for weeks to months after surgery. Additionally, current treatments fail in a significant proportion of cases, necessitating repeat surgeries that can result in permanent vision loss.
Innovative Approach to Retinal Repair
PYK-2101 represents a fundamentally different approach to retinal repair. As a biodegradable hydrogel sealant, it directly seals retinal breaks without obscuring vision, potentially eliminating the need for restrictive post-operative positioning requirements.
"For many patients and providers, retina surgery is synonymous with post-operative burdens, including face-down positioning for 23 hours a day, impaired vision, and inability to travel by air for weeks to months," explained Tomasz Stryjewski, MD, Chief Scientific Officer and Pykus cofounder. "PYK-2101 has the potential to transform surgical outcomes and improve accessibility for patients who would benefit from vitrectomy."
Clinical and Market Context
Retinal detachment occurs when the light-sensitive tissue at the back of the eye separates from its supporting layers, potentially leading to permanent vision loss if not promptly treated. Nearly two million vitrectomies—retinal surgeries—are performed annually worldwide, with retinal detachment being among the most common indications.
The technology behind PYK-2101 was originally developed at and licensed from Mass Eye and Ear (now part of Mass General Brigham) at Harvard Medical School. Pykus Therapeutics, founded to commercialize this innovation, is positioning the treatment as a first-in-class solution that could significantly improve patient outcomes and experience.
Regulatory Pathway
Following the completion of the current trial, Pykus intends to submit an Investigational Device Exemption (IDE) application to the FDA in the fourth quarter of 2025 for a multicenter U.S. pivotal trial. This timeline depends on financing and regulatory discussions. The company plans to meet with the FDA in the third quarter of 2025 to discuss its clinical development program and proposed pivotal trial design, which it believes aligns with the FDA's recent perspectives on endotamponade development.
If successful, PYK-2101 could address significant unmet needs in retinal surgery, potentially improving visual outcomes while dramatically enhancing patient comfort and quality of life during the recovery period.
