AbbVie Korea has launched XEN 63, a new option for treating glaucoma in patients whose intraocular pressure (IOP) is not controlled by previous glaucoma surgery or conventional medications.

XEN 63 is an innovative solution for treating glaucoma, one of the leading causes of blindness, that utilizes micro-incision glaucoma surgery (MIGS) to control patients' intraocular pressure.

The XEN Gel Implant, a treatment option for patients whose IOP is uncontrolled by conventional treatments, is a small, six-millimeter-long tube-shaped gel implant that can be inserted through minimally invasive glaucoma surgery (MIGS), which minimizes the scope of the incision compared to traditional glaucoma filtration surgery.

XEN 63 is designed with a 1.4 times larger inner diameter (63 microns (μm)) than the company's previous product, XEN 45, for lower outflow resistance, making it a treatment option for patients who require greater IOP reduction.

According to statistics from the Health Insurance Review and Assessment Service, the number of glaucoma patients in Korea is expected to reach more than 1.2 million by 2024. This is an increase of more than 25 percent from 2019 (970,000). While the majority of patients are over 60 years old, those in their 20s and 30s account for approximately 10 percent of the total.

Glaucoma is a condition in which the optic nerve in the eye becomes increasingly weak, causing a narrowing of vision. It is the leading cause of blindness worldwide. Intraocular pressure management plays a crucial role in the treatment of glaucoma, and it is essential to tailor treatment to each patient's condition and needs.

The primary treatment for glaucoma is medication, but a study of 1,046 glaucoma patients in Korea found that about 27.4 percent of patients did not use their prescribed medications properly, leading to low patient adherence and potentially increasing the risk of disease progression and vision loss.

“The XEN Gel Implant is an option for glaucoma patients who have had difficulty achieving adequate IOP control with conventional treatments, with minimal surgical burden, while providing a combination of therapeutic effectiveness and safety,” Professor Sung Kyung-rim of the Department of Ophthalmology at Asan Medical Center said. “The introduction of XEN 63 with a 63-micron inner diameter, following the 45-micron XEN 45, is expected to provide a wider range of treatment options for patients who require surgical treatment.”

XEN 63 demonstrated significant treatment outcomes in a multicenter, non-randomized, uncontrolled, prospective clinical study evaluating the efficacy and safety of XEN 63 in 80 patients with primary open-angle glaucoma whose IOP was uncontrolled with conventional medications.

According to the clinical results of 80 patients who underwent XEN 63 implantation alone or in combination with cataract surgery, 68.8 percent of all patients demonstrated surgical success one year after surgery, with a reduction in IOP of 20 percent or more from preoperative levels, with or without glaucoma medication, while achieving absolute IOP readings in the range of 6 to 18 mm Hg.

Notably, 62.5 percent of patients achieved a stable IOP of 18 mm Hg or less after surgery, with more than a 20 percent IOP reduction from pre-op, without the need for glaucoma medication.

In addition, the mean IOP of all patients was 32.2 percent lower at one year post-op compared to pre-op, and the mean number of IOP-lowering medications was reduced from 2.3 pre-op to 0.3 at one year post-op, demonstrating statistically significant IOP-lowering effectiveness and a reduced medication burden with XEN 63.

At the one-year follow-up, adverse events in both the XEN 63 alone and XEN 63 plus cataract groups were mainly mild and resolved with conservative treatment.

Transient hypotony was observed in 42.5 percent of eyes during the early postoperative period (days 1 and 1 week), with 29 of these eyes recovering within one month, and all eyes normalized by six months. There was only one case of hypotensive retinopathy, and best-corrected visual acuity (BCVA) returned to preoperative levels two months after stent removal.

The long-term clinical effectiveness of XEN 63 was demonstrated in a multicenter, single-arm, non-randomized, prospective clinical study conducted in Austria, Canada, and Germany.

In a study of 64 patients with primary open-angle glaucoma, the treatment effect was maintained without further surgery for four years in 64% of patients who could be followed up. The average annual surgical failure rate over the five years was about 10 percent, which is comparable to invasive surgeries, such as trabeculectomy and tube placement.

“About 45 percent of glaucoma patients experience progression of glaucoma despite medication, and XEN 63 is a new treatment option for patients who experience progression of glaucoma despite medication, providing a safe, effective, and personalized treatment,” AbbVie Korea’s Executive Vice President for Medical Affairs, Kang Ji-ho, said. “We will do our best to provide more suitable treatment options for glaucoma patients in Korea with our portfolio of XEN gel implants.”