Pykus Therapeutics announces completion of enrollment in PYK-2101 clinical trial

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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."

(Image courtesy Pykus Therapeutics)

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.

References:

1. Pykus Therapeutics completes trial enrollment for PYK-2101, a novel retinal sealant for the treatment for retinal detachment. Published April 10, 2025. Accessed April 10, 2025. https://www.prnewswire.com/news-releases/pykus-therapeutics-completes-trial-enrollment-for-pyk-2101-a-novel-retinal-sealant-for-the-treatment-for-retinal-detachment-302425434.html