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XEN63 Gel Stent shows sustained glaucoma control over 3 years

Ophthalmology 360

Key Takeaways

  1. The XEN63 Gel Stent significantly reduced intraocular pressure and glaucoma medication use over 3 years.
  2. Overall surgical success at 36 months was 67.1%, with higher success rates in standalone procedures than combined cataract surgery cases.
  3. Most early hypotony cases resolved within 1 month, though rare serious complications were reported.

The XEN63 Gel Stent provided sustained intraocular pressure (IOP) reduction and reduced medication use over 3 years in patients with primary open-angle glaucoma, according to findings from a prospective multicenter study.

The study included 85 patients with medically uncontrolled primary open-angle glaucoma who underwent either standalone XEN63 Gel Stent implantation or implantation combined with phacoemulsification. Surgical success at 36 months was defined as achieving an IOP between 6 and 18 mmHg with at least a 20% reduction from baseline without glaucoma medications.

At 36 months, the overall surgical success rate was 67.1%. Higher success was observed in the standalone group compared with the combined surgery group (78.3% vs 53.9%; P = 0.0173). Complete success was achieved in 45.9% of the total cohort.

Mean preoperative IOP decreased from 21.3 mmHg to 14.3 mmHg at the last follow-up visit (P < 0.0001). The average number of glaucoma medications also declined significantly, from 2.3 medications at baseline to 0.7 medications at follow-up (P < 0.0001).

Researchers reported that the type of surgical approach did not significantly affect the degree of IOP reduction. Numerical hypotony, defined as IOP below 6 mmHg, occurred in 23.5% of eyes on postoperative day 1 but resolved in 95% of cases by month 1.

Adverse events included 1 case of hypotonic maculopathy requiring device explantation, 1 case of endophthalmitis at month 30, and 1 case of retinal detachment at month 26. Secondary needling procedures were required in 8.2% of eyes.

Reference

Martínez-de-la-Casa JM, Marcos-Parra MT, Millá-Griñó E, et al. Three-Year Outcomes and Safety of the XEN63 Gel Stent: A Multicenter Prospective Study in Primary Open-Angle Glaucoma. J Clin Med. 2026;15(9):3528. doi: 10.3390/jcm15093528. PMID: 42123261.

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