Pykus Therapeutics completes enrollment in trial evaluating PYK-2101

Author(s):

Martin David Harp

Key Takeaways

PYK-2101 is a first-in-class biodegradable retinal hydrogel sealant for retinal detachment surgery, aiming to improve visual recovery without obscuring vision.
The pilot study in Australia evaluates safety and tolerability of PYK-2101 in 11 patients over 16 weeks, focusing on anatomical attachment and visual acuity recovery.
Success of PYK-2101 could transform vitreoretinal surgery by eliminating intraocular gas, reducing patient anxiety and improving post-surgery experience.
Pykus Therapeutics plans to submit an IDE application to the FDA in Q4 2025 for a multicenter US pivotal trial, with discussions scheduled for Q3 2025.

PYK-2101 is a focal hydrogel retinal sealant for use in patients undergoing surgery for a detached retina.

(Image Credit: AdobeStock/MrPanya)

Pykus Therapeutics announced it has completed enrollment in its pilot study, PYK-2101-RD00, evaluating PYK-2101, a focal hydrogel retinal sealant, in patients undergoing surgery for detached retina.

PYK-2101 is a first-in-class biodegradable retinal hydrogel sealant, with an initial prospective indication for the treatment of retinal detachment. The company states that “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.”

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 in Australia. The main objective of the 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.

"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. "Eliminating the need for intraocular gas would be transformative for patients undergoing vitrectomy, addressing a significant source of patient anxiety."

The company stated it intends to submit an Investigational Device Exemption (IDE) application to the FDA in Q4 2025 for a multicenter US pivotal trial. Additionally, the company plans to meet with the FDA in Q3 2025 to discuss its ongoing clinical development and its proposed pivotal trial design.