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.
Pykus Therapeutics' PYK-2101 achieves positive interim clinical trial results
FDA accepts Novo Nordisk's filing application for oral semaglutide 25 mg
Nutshell Therapeutics' NTS071 p53 allosteric reactivator cleared for US clinical trial
Blue Earth Therapeutics initiates Phase 2 trial in metastatic castrate resistant prostate cancer
Armata Pharmaceuticals' AP-SA02 clinical trial receives additional US DoD funding
BioArctic receives SEK101.7m in royalties from Q1 Leqembi sales
SKNV launches Kefunova Cream for actinic keratosis and superficial basal cell carcinoma
Ingenium Therapeutics' Gengleucel to enter Phase 2 trial in MRD+ AML following FDA feedback
Nuformix receives positive EMA opinion for orphan drug designation of NXP002 in IPF
MHRA to review monthly maintenance dosing for Leqembi in early Alzheimer's treatment
Ro integrates with NovoCare Pharmacy to offer access to all doses of Wegovy at lowest price
Myosin Therapeutics receives grant to advance MT-110 clinical trial in methamphetamine use disorder
CSL Vifor and Travere Therapeutics gain full EU approval for FILSPARI in IgA nephropathy