The Xen45 gel stent can provide long-term IOP reduction in patients with refractory glaucoma while offering a more favorable safety profile as well as relief from multiple ocular symptoms, according to a poster presented at the American Academy of Ophthalmology meeting in New Orleans.
“The improvement in symptoms is likely related to reduced medication use,” Joseph F. Panarelli, MD, lead author of the poster, said in a follow-up interview with Ocular Surgery News.
The Xen45 gel stent (Allergan) is a MIGS device that is implanted ab interno to create a diffuse outflow from the anterior chamber to the subconjunctival space. After a 12-month study to evaluate efficacy and safety as a stand-alone procedure, the Xen implant was cleared by the FDA in 2016 for the management of refractory glaucoma.
The post hoc study presented in the poster specifically addressed ocular symptoms as an indicator of quality of life over a period of 1 year after implantation. Fifty-two patients filled in a modified Collaborative Initial Glaucoma Treatment Study questionnaire at baseline and then at 1, 3, 6 and 12 months postoperatively. Participants were asked to report on seven symptoms, including eye irritation/burning, eye pain, excessive tearing, droopy eyelids, red eyes, foreign body sensation and skin sensitivity around the eye. Other parameters measured were mean IOP changes and variations in the number of medications over the study period, as well as the correlation between symptoms and number of medications used at 12 months.
“We wanted to evaluate whether symptoms improved with the decrease or discontinuation of medication use and whether or not the surgery itself caused a worsening of symptoms,” Panarelli said.
Overall, 69.2% of patients reported a reduction in the number of IOP-lowering medications from baseline at 12 months, with 38% of patients being medication-free. None reported an increase in medication use. For most ocular symptoms, patients who experienced a change in severity/bothersomeness reported an improvement at 12 months postoperatively. A clinically significant decrease from baseline in the incidence of eye irritation/burning and skin sensitivity/irritation around the eye was observed at 12 months postoperatively. Among patients who reported ocular symptoms at baseline, 43% to 82% had a complete response — that is, no symptoms — at 12 months postoperatively, depending on the symptom.
“The improvement in symptoms occurred early and was likely related to the observed reduction in medication use. It is important to note that most patients also did not note a worsening of symptoms, which we commonly find with more traditional glaucoma surgeries, such as glaucoma drainage devices and trabeculectomy,” Panarelli said.
The Xen stent adds to the armamentarium of glaucoma specialists who deal with refractory glaucoma and may additionally provide relief from the bothersome side effects of medications as well as other aspects that make medical therapy a burden for patients.
“Patients are happier when they don’t have to remember to pick up their medicines each month, pay for them each month and remember to instill them multiple times a day,” Panarelli said. – by Michela Cimberle
- Panarelli JF, et al. Patient reported outcome results in the Xen 45 gel stent pivotal trial in patients with refractory glaucoma. Presented at American Academy of Ophthalmology annual meeting; Nov. 11-14, 2017; New Orleans.
- For more information:
- Joseph F. Panarelli, MD, can be reached at New York Eye and Ear Infirmary of Mount Sinai, 310 E. 14th St., Suite 319S, New York, NY 10003; email: firstname.lastname@example.org.
Disclosure: Panarelli reports he is a consultant for Allergan and Aerie Pharmaceuticals and is a speaker for Glaukos.