Positive interim pilot clinical trial results of PKY-2101

(Image credit: AdobeStock/xixinxing)

Pykus Therapeutics share that its ongoing pilot study evaluating the use of its lead product candidate, PYK-2101, a focal hydrogel retinal sealant, saw positive results in patients undergoing surgery for detached retina.

The retinal attachment rate in this trial exceeded the FDA target rate for ocular endotamponades; potential for rapid vision recovery was demonstrated; and no safety concerns were raised.

In the company’s press release¹, Dean Eliott, MD, Stelios Evangelos Gragoudas Professor of Ophthalmology at Harvard Medical School at Massachusetts Eye and Ear Infirmary, and Director of the Retina Fellowship at Harvard/Mass. Eye and Ear noted the how this results may benefit the future of retinal surgery, saying, “PYK-2101 has the potential to offer enormous benefits to patients undergoing retinal detachment surgery. Following surgery, patients currently must remain in a prone, ‘face-down’ position almost 24 hours per day, must contend with work and travel restrictions, and have poor vision for weeks following surgery. By improving vision and eliminating ‘face-down’ positioning, this product could offer a transformative improvement in retinal detachment surgery."

PYK-2101-RD001 is a prospective, multicenter, open-label pilot trial being conducted in Australia, examining the use of PYK-2101 in 11 patients with retinal detachment undergoing pars plana vitrectomy. This study aims 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.

To date, the trial reports:

• No serious AEs or SAEs, and no direct effects of PYK-2101 on IOP were observed.
• PYK-2101 has demonstrated a single surgery retinal attachment rate of 91% in the per protocol (PP) population and 73% in the intent to treat (ITT) population¹ vs. an FDA target rate of 72%.
• PYK-2101 demonstrates potential for rapid vision recovery (Figure 1).

Figure 1. PYK-2101 demonstrates rapid vision recovery following surgery

(Used with permission from Pykus Therapeutics)

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.

Reference:

1. Pykus Therapeutics Announces Positive Interim Pilot Clinical Trial Results of PYK-2101, a Novel Retinal Sealant. Pykus Therapeutics. May 2, 2025. Accessed May 2, 2025.