Pykus Therapeutics has presented “positive” clinical data from its PYK-2101-RD001 ongoing pilot trial of its focal hydrogel retinal sealant, PYK-2101, for use in individuals undergoing retinal detachment surgery.
The study’s findings suggest that the retinal attachment rates exceeded the FDA target rate for ocular endotamponades, indicating a potential for quick vision recovery without any safety concerns being raised.
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The multicentre, open-label trial is investigating the sealant’s use in 11 retinal detachment subjects undergoing pars plana vitrectomy.
Being carried out at vitreoretinal clinics in Australia, the trial’s primary goal is to assess the tolerability and safety of the sealant within the first 16 weeks after pars plana vitrectomy.
The trial’s outcome measures include the speed of visual acuity recovery, anatomical attachment rate, cataract progression degree, change in intraocular pressure, and adverse events.
Findings demonstrated no serious adverse events (AEs) or severe adverse events (SAEs).
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By GlobalDataAccording to the company, PYK-2101 has shown a 91% single-surgery retinal attachment rate in the per-protocol population and 73% in the intent-to-treat population, surpassing the US regulator’s target rate of 72%.
PYK-2101 is stated to be a patented, biodegradable hydrogel designed to seal retinal breaks directly, enhancing visual recovery post-surgery without the need for individuals to maintain a face-down position.
It aims to improve the patient experience against the current standard-of-care, which requires the use of intraocular gases or silicone oil as endotamponade agents for filling the eye.
Based in the US, Pykus focuses on developing treatments for retinal and other ophthalmic conditions.
The company is leveraging technology initially developed and licenced from Mass Eye and Ear (now part of Mass General Brigham) at Harvard Medical School, US, to offer solutions to enhance surgical outcomes and individual care.
