Pykus Therapeutics Completes Enrollment in Pilot Trial of PYK-2101 Retinal Sealant for Retinal Detachment Surgery

Pykus Therapeutics has successfully completed patient enrollment in its pilot clinical study, PYK-2101-RD00, evaluating PYK-2101—a novel focal hydrogel retinal sealant—for use in retinal detachment surgeries.

Overview of PYK-2101 Retinal Sealant

PYK-2101 is a first-in-class, biodegradable hydrogel designed specifically to seal retinal breaks during surgery for retinal detachment. Unlike traditional approaches that utilize intraocular gas, PYK-2101 enables direct sealing of retinal breaks without obscuring vision and eliminates the need for face-down positioning postoperatively—a common source of discomfort and anxiety for patients.

The company highlights that this innovative approach may significantly enhance and accelerate visual recovery after retinal detachment procedures.

Details of the PYK-2101-RD001 Pilot Study

The pilot study, PYK-2101-RD001, is a prospective, multicenter, open-label trial conducted in Australia, involving 11 patients undergoing pars plana vitrectomy for retinal detachment.

Primary Study Objectives

The main goal is to evaluate the safety and tolerability of PYK-2101 within the first 16 weeks post-surgery. Secondary outcome measures include:

       • Anatomical attachment rate

       • Speed of visual acuity recovery

       • Degree of cataract progression

       • Changes in intraocular pressure

       • Incidence of adverse events

Expert Commentary: A Potential Paradigm Shift

Dr. John Pollack, MD, FASRS and past-president of the American Society of Retina Specialists, emphasized the potential impact of this new technology:

“Should PYK-2101 prove successful in clinical trials, it will represent a paradigm shift in vitreoretinal surgery. Eliminating the need for intraocular gas would be transformative for patients undergoing vitrectomy, addressing a significant source of patient anxiety.”

Next Steps: Regulatory Plans and Pivotal Trial

Pykus Therapeutics has announced its plans to submit an Investigational Device Exemption (IDE) to the U.S. FDA in Q4 2025, in preparation for a multicenter pivotal trial in the U.S. Additionally, the company intends to meet with the FDA in Q3 2025 to discuss its ongoing clinical development strategy and proposed pivotal trial design.