Market Scope: Safer and More Effective Glaucoma Surgical Options Expected to Double Global Revenue by 2027
Nearly 48 million individuals are diagnosed with glaucoma globally, but just over a million, or 2.2 percent, will have surgery in 2022. However, safer and more effective surgical devices over the next 5 years will increase the percentage of glaucoma patients treated surgically to a projected 3.5 percent, according to a Market Scope report.
In the past 6 months, a handful of new surgical devices—microstents and canal-based surgical devices—have become available to glaucoma surgeons in the US and Europe.
Market Scope’s global “2022 Glaucoma Surgical Device Market Report” looks at how these new surgical options will help drive glaucoma device revenue from just over $800 million in 2022 to nearly $1.7 billion by 2027.
New Canal-Based Surgery Devices
Glaukos, the world’s glaucoma market device leader, recently announced the availability of two new canal-based surgery devices: the iPrime viscoedelivery system and iAccess trabecular trephine device. Glaukos gained 510(k) clearance of the iPrime, a sterile, single-use, minimally invasive device for the delivery of viscoelastic fluid during ophthalmic surgery, in January 2022. The specifications of this product have yet to be published, but Glaukos plans to launch it in the US in the second half of 2022.
Glaukos’ iAccess, a Class I trabecular trephine device, began full US commercialization in the latter part of the first quarter of 2022. Its purpose is similar to currently available goniotomy devices, but this device cores and removes the trabecular meshwork, instead of cleaving it. The tip of the instrument has a cylindrical blade used to remove a 220 µm core of trabecular meshwork tissue that is 300 µm in depth. Surgeons who have used the device describe it as producing a much smaller goniotomy. The device was available to some surgeons in Q1-2022, even though it was not shown at the 2022 ASCRS meeting.
In March 2022, New World Medical launched the Streamline surgical system, a single-use device designed to perform goniotomy and viscodilation. It features what the company describes as intuitive ClickPulse technology to create precise goniotomies in the trabecular meshwork and deliver small amounts of OVD into Schlemm’s canal in one unified step. The device can be used in a standalone procedure or combined with cataract surgery. It gained 510(k) clearance in October 2021. Full commercialization began in early April 2022. The Streamline is capable of injecting 56 µl of viscoelastic into Schlemm’s canal, delivered in eight ClickPulse applications. The inner cannula, illustrated in the adjacent figure, protrudes into Schlemm’s canal to deliver small amounts of viscoelastic in both directions within the canal. The addition of the Streamline is expected to expand the company’s presence in glaucoma surgery, adding to its leadership position in tube shunts and goniotomy knives (Kahook Dual Blade).
New Microstents
The iStent Infinite targets patients with advanced glaucoma. It gained FDA 510(k) clearance in August 2022. The device consists of three heparin-coated trabecular bypass stents identical to the iStent SA. The device is intended to provide titratable stent therapy, with a second and third iStent Inject able to lower IOP more than a single implant. Clinical trial results reported by Glaukos showed 76 percent of patients achieved a 20 percent or greater reduction in IOP from baseline on the same or lower ocular hypotensive medication. Fifty percent of subjects achieved a 30 percent or greater reduction in mean diurnal IOP from baseline. The company is expecting the iStent Infinite to target the most difficult to treat patients who are using an average of 3.1 IOP lowering medications and have already failed previous glaucoma surgery.
Market Scope’s Q1-2022 Survey of US Ophthalmologists asked surgeons who treat glaucoma about their plans to adopt the iStent Infinite. Twenty percent said they would begin implanting the device right away, while a third said they would wait for feedback from early adopters. Nearly 35 percent were undecided. Only 11.6 percent indicated they didn’t plan to offer it.
iSTAR Medical is a private, venture capital-backed company based in Belgium that is developing the MINIject implant. The device, made of medical grade silicone with antifibrotic material, is implanted in the suprachoroidal space to treat primary open-angle glaucoma. The company first used its proprietary material in an implant called the STARflo, designed to function as a bleb-free, microporous drainage system to reduce IOP by increasing the eye’s natural uveoscleral outflow. The STARflo is implanted during a trabeculectomy procedure. The MINIject is a more recent development implanted using the ab interno approach to enhance aqueous humor outflow from the anterior chamber to the suprachoroidal space. It is implanted using a disposable handpiece. The implant is 5 mm long and is designed to conform to the eye anatomy. It benefits from sustained drainage efficacy over time due to the biointegration of surrounding tissues into the material, with what the company describes as a natural flow speed reducing the incidence of fibrosis and minimizing scarring.
Two-year clinical results from the STAR-I trial and initial data from the STAR-II European trial showed promising outcomes. Both studies showed a reduction in IOP in more than 50 patients with open-angle glaucoma following standalone MINIject implantation. In the STAR-I trial, the mean reduction in IOP in patients implanted with MINIject remained consistent around 40 percent throughout the study. Nearly half of the patients were medication-free at the trial’s conclusion, with a mean reduction of nearly one (0.8) IOP-lowering medication. A minimal reduction in corneal endothelial cell density was observed.
In July 2022, AbbVie and iSTAR announced that AbbVie would pay $60 million up front in a partnership to further develop and commercialize the MINIject. AbbVie holds exclusive rights to acquire iSTAR after completion of the STAR-V pivotal study. AbbVie’s Allergan unit sells other glaucoma microstents, including the XEN Gel Stent.
Market Scope’s “2022 Glaucoma Surgical Device Market Report” was published in August. For more information, visit market-scope.com or contact Matthew Douty at matthew@market-scope.com.