US-based pharmaceutical company Pykus Therapeutics Inc announced on Friday the presentation of positive clinical data from its ongoing pilot study evaluating the use of its proprietary, lead product candidate, PYK-2101, a focal hydrogel retinal sealant, in patients undergoing surgery for detached retina.
The company said that 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. Interim results from PYK-2101-RD001 were presented by Pykus at Eyecelerator at Park City on 2 May 2025.
PYK-2101-RD001 is a prospective, multicentre, open-label pilot trial examining the use of PYK-2101 in 11 patients with retinal detachment undergoing pars plana vitrectomy. The objective of this 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. The study is being conducted at leading vitreoretinal clinics in Australia.
PYK-2101 is a patented, first-in-class biodegradable retinal hydrogel sealant. Pykus is pursuing an initial indication for the treatment of retinal detachment.
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