"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."
"We are thrilled to complete enrollment of our open-label pilot trial," said Tomasz Stryjewski, MD, Chief Scientific Officer and Pykus cofounder. "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. PYK-2101 has the potential to transform surgical outcomes and improve accessibility for patients who would benefit from vitrectomy."
PYK-2101-RD001 is a prospective, multicenter, open-label pilot trial examining the use of PYK-2101 in 11 patients with retinal detachment undergoing pars plana vitrectomy (Figure 1). The objective of this study is to evaluate the safety and tolerability of PYK-2101 within the first 16 weeks post vitrectomy. Outcome measures include anatomical attachment rate, speed of visual acuity recovery, degree of cataract progression, change in intraocular pressure, and adverse events. The study is being conducted at leading vitreoretinal clinics in Australia.
Pykus intends to submit an Investigational Device Exemption (IDE) application to the FDA in Q4 2025 for a multicenter U.S. pivotal trial, pending financing and regulatory discussions. The Company plans to meet with FDA in Q3 2025 to discuss its ongoing clinical development and its proposed pivotal trial design, which the company believes is consistent with FDA's recent views on endotamponade development.
About PYK-2101:
PYK-2101 is a patented, first-in-class biodegradable retinal hydrogel sealant. The Company is pursuing an initial indication for the treatment of retinal detachment. PYK-2101 offers the opportunity to dramatically improve and accelerate visual recovery following retinal detachment surgery by sealing retinal breaks directly without having to obscure vision, while eliminating the need for patients to position "face-down" after surgery. Compared to the current standard-of-care, which involves filling the eye with endotamponade agents such as intraocular gases or silicone oil, PYK-2101 aims to dramatically enhance the patient experience and improve surgical outcomes.
About Retinal Detachment Surgery and Vitrectomy Surgery:
Nearly two million retinal surgeries, or vitrectomies, are performed annually worldwide. Retinal Detachment is amongst the most common indications for undergoing retinal surgery. The current standard-of-care for retinal detachment surgery exposes patients to significant post-operative burdens, prolonged visual recovery, and fails in a high proportion of cases, requiring repeat surgery resulting in permanent vision loss.
About Pykus Therapeutics:
Pykus Therapeutics, Inc., based in Cambridge, MA, is a clinical-stage, medical technology company dedicated to advancing treatments for retinal and other ophthalmic diseases. Using technology originally developed by and licensed from Mass Eye and Ear (now part of Mass General Brigham) at Harvard Medical School, Pykus aims to deliver transformative solutions to improve surgical outcomes and enhance patient care.
For more information, please visit www.pykustherapeutics.com.
