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April 08, 2021
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BLOG: Surgeon-industry partnerships vital for advancing glaucoma care

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The first time I learned about the Xen gel stent, it was 2014, and the device was in development with AqueSys; I was at a consultants’ meeting with Rick Lewis, MD, and many other innovative surgeons who were involved.

Its beauty, I thought, was in its simplicity — I was very intrigued. At the time, most of the MIGS work was being done ab interno, the planned approach for this device. The original clinical trial with Xen was challenging because the FDA did not allow the use of mitomycin and the eyes had to have prior incisional surgery.

When Allergan acquired AqueSys and the Xen, I was invited to travel to Panama with a group of surgeons to gain experience implanting the device and to offer feedback to the company. Not only did I have the opportunity to place the device in some very sick eyes, but I also had the chance to learn from several outstanding surgeons who were implanting the Xen. Postoperatively, we saw the excellent results this device could provide for patients with challenging cases of glaucoma.

Jason Bacharach

Once the Xen was approved in the United States, I incorporated it into my practice — using the ab interno procedure. Among other innovative surgeons, my friend Dan Jewelewicz, MD, (who also happens to be my dad’s doctor) began implanting the device ab externo. Posting his cases on the American Glaucoma Society’s online chat, Dan showed how he was able to place the Xen through a pinhole via an ab externo approach with a small-gauge needle, creating a low-lying posterior bleb. I was amazed and immediately incorporated that technique. I felt the benefits for patients included no open incision and a truly microincisional procedure. As the owner of a clinical practice, finances came into play, as placing the Xen from an ab externo approach provided better remuneration.

Because it can be done as a stand-alone procedure or in conjunction with cataract surgery, Xen gives us flexibility and diversity over some of the other device-based MIGS whose on-label approval is for use in conjunction with cataract surgery only.

My ability to offer this improved procedure to my patients was a direct result of my having a partnership with Allergan. The opportunity to go to Panama and learn about Xen implantation from surgeons such as Vanessa Vera gave me the confidence to go home and incorporate the procedure into my repertoire. Without that invitation, I may have sat on the sidelines.

Today we are seeing more innovation from the likes of Ike Ahmed and Arsham Sheybani, further improving our techniques. Sébastien Gagné from Montreal places the Xen at the slit lamp. Imagine the following scenario: A patient comes into the office on a Friday afternoon with a pressure of 40 mm Hg. Instead of waiting to bring the patient to the OR the following week, we place the stent at the conclusion of our consultation.

To me, not only has the introduction of Xen been a big step forward, but the evolution of the surgical technique has been incredible. This trajectory shows the ingenuity of my fellow surgeons who do not accept the status quo — they innovate and teach other surgeons how to achieve better results for our patients.

Allergan made it possible for surgeons to blaze the path forward with this technology. When the company acquired the device, it retained key team members who had a long history with Xen for continuity. One of those experts is Mitch Brown, Allergan’s senior director of physician training. In fact, Mitch was a key part of my Panama experience. This journey is not just about the device, it is about the collegiality of surgeons and industry innovating together.

References:

  • AqueSys Xen 45 glaucoma implant in refractory glaucoma. https://clinicaltrials.gov/ct2/show/NCT02036541.
  • Lewis RA. J Cataract Refract Surg. 2014;doi:10.1016/j.jcrs.2014.01.032.
Sources/Disclosures

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Disclosures: Bacharach reports he is a consultant/advisor to Aerie, Allergan, Bausch + Lomb, Eyepoint, Eyevance, Glaukos, Humphrey-Zeiss, Imprimis, Injectsense, Iridex, New World Medical, Ocular Therapeutix, Omeros, Osmotica/RVL, Santen, Topcon and Vertical; receives lecture fees from Aerie, Allergan, Bausch + Lomb, Bryn Mawr Communications, Evolve, Iridex, Sun and Vindico; receives grant or research support from Aerpio, Biorasi, Equinox, Eyepoint, Glaukos, Injectsense, Insite Vision, Kala, Lexitas, Nicox, Novartis, Ocular Therapeutix, Oculis, Oculos, Ocuphire, Ora, Orasis, Osmotica/RVL, Perrigo, Salvat, Santen, Sight Science, Sun, Surface, Tarsius and Trefoil; and has equity/stock ownership in OnPace.