Alcon's New Glaucoma Milestone

Glaucoma is the leading cause of irreversible vision loss and the second leading cause of blindness worldwide.¹ Primary open-angle glaucoma affects an estimated 68.6 million people globally; more than 3 million of those patients live in the U.S.^2-3 There is a significant unmet patient need in the glaucoma space, underpinning the importance of expanded access to treatment options across the globe.

At the beginning of 2022, Alcon reaffirmed our commitment in glaucoma with our acquisition of Ivantis, Inc. Our goal was simple: to introduce Hydrus^® Microstent, a minimally invasive glaucoma surgery (MIGS) device, proven to lower intraocular pressure in patients with mild to moderate primary open angle glaucoma in conjunction with cataract surgery, on a broader, global scale.^* We have already made strides towards that goal, recently exceeding 100,000 implants worldwide – a meaningful milestone as we work to expand our footprint in the surgical ophthalmology and glaucoma space.

Hydrus Microstent is the first and only MIGS device to report clinical results from a pivotal trial at five years, through the HORIZON clinical study.⁴ More than three-quarters of patients in the study (77.2%) saw a significant reduction in eye pressure at 24 months. Two-thirds (66%) of patients remained medication-free at five years, and we saw more than 50% relative reduction in incidence of incisional Secondary Surgical Interventions (SSIs) versus cataract surgery (CS) alone (2.4% in Hydrus versus 5.3% in CS only) over the 5-year follow-up.^**,4-6

Alcon has been showcasing Hydrus Microstent at ophthalmic and glaucoma conferences, including the American Glaucoma Society meeting (March), the American Society of Cataract and Refractive Surgery Annual Meeting (April), the International Conference on Glaucoma Surgery (April), the European Glaucoma Society meeting (June) and the U.S. Glaucoma Patient Summit (June). Our future glaucoma plans include continued research on Hydrus Microstent as we work to deliver this technology to even more patients across the globe.

^*Currently approved for stand-alone use and commercialized in the U.K., Canada, Australia, Singapore and Germany.

^**Includes trabeculectomy, tube shunt, gel stent, ECP/TSCP, non-penetrating; (9/369 Hydrus and 10/187 CS).

Hydrus® Microstent Important Safety Information

IMPORTANT PRODUCT INFORMATION

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

INDICATIONS FOR USE: 
The Hydrus Microstent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).

CONTRAINDICATIONS: 
The Hydrus Microstent is contraindicated under the following circumstances or conditions: (1) In eyes with angle closure glaucoma; and (2) In eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber (AC) angle.

WARNINGS: 
Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The surgeon should periodically monitor the status of the microstent with gonioscopy to assess for the development of PAS, obstruction of the inlet, migration, or device-iris or device-cornea touch. The Hydrus Microstent is intended for implantation in conjunction with cataract surgery, which may impact corneal health. Therefore, caution is indicated in eyes with evidence of corneal compromise or with risk factors for corneal compromise following cataract surgery. Prior to implantation, patients with history of allergic reactions to nitinoll, nickel or titanium should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials.

PRECAUTIONS: 
If excessive resistance is encountered during the insertion of the Microstent at any time during the procedure, discontinue use of the device. The safety and effectiveness of use of more than a single Hydrus Microstent has not been established. The safety and effectiveness of the Hydrus Microstent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with preexisting pseudophakia, eyes with pseudoexfoliative or pigmentary glaucoma, and when implantation is without concomitant cataract surgery with IOL implantation. Please see a complete list of Precautions in the Instructions for Use.

ADVERSE EVENTS: 
The most frequently reported finding in the randomized pivotal trial was peripheral anterior synechiae (PAS), with the cumulative rate at 5 years (14.6% versus 3.7% for cataract surgery alone). Other Hydrus postoperative adverse events reported at 5 years included partial or complete device obstruction (8.4%) and device malposition (1.4%). Additionally, there were no new reports of persistent anterior uveitis (2/369, 0.5% at 2 years) from 2 to 5 years postoperative. There were no reports of explanted Hydrus implants over the 5-year follow-up. For additional adverse event information, please refer to the Instructions for Use.

MRI INFORMATION: 
The Hydrus Microstent is MR-Conditional, meaning that the device is safe for use in a specified MR environment under specified conditions.

Please see the Instructions for Use for complete product information.

References

1. Tham YC, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systemic review and meta-analysis. Ophthalmology. 2014;121(11):2081-2090.
2. Zhang, N., Wang, J., Li, Y. et al. Prevalence of primary open angle glaucoma in the last 20 years: a meta-analysis and systematic review. Sci Rep 11, 13762 (2021). https://doi.org/10.1038/s41598-021- 92971-w.
3. Market Scope 2021 Glaucoma Surgical Device Market Report: 2020-2026. July 2021.
4. Hydrus Microstent Instructions for Use; ClinTrials.gov (NCT01539239).
5. Ahmed I, et al; HORIZON Investigators. Long-term Outcomes from the HORIZON Randomized Trial for a Schlemm’s Canal Microstent in Combination Cataract and Glaucoma Surgery. https://www.aaojournal.org/article/S0161-6420(22)00160-9/fulltext.
6. Hydrus Microstent Instructions for Use. US DFU, p.23, Table 9, Cumulative Incisional SSIs.

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