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hydrus microstent logo

 

 

Your MIGS Choice Matters

 

The first and only MIGS device to report significant safety and effectiveness outcomes from a pivotal trial at 5 years.1,2

 

Your MIGS Choice Matters

 

The first and only MIGS device to report significant safety and effectiveness outcomes from a pivotal trial at 5 years.1,2

 

Hydrus® Microstent: 

 

Leading the Way For Evidence-Based Outcomes

 

The Hydrus® Microstent received the highest quality of clinical data rating given among all MIGS, in the 2020 AAO Primary Open-Angle Glaucoma Preferred Practice Pattern guidelines.3*

A gold seal indicating that the Hydrus Microstent received the highest quality of clinical data rating in the 2020 American Academy of Ophthalmology Preferred Practice Pattern guidelines.
The first visual is of an eye, with a droplet, and copy says 2/3 patients medication free.
The first visual is of an eye, with a droplet, and copy says 2/3 patients medication free.

59% of Hydrus® Microstent patients remained medication-free at 5 years4†

The second visual is a scalpel with an arrow pointing downwards, and copy says >50% reduction in secondary surgical intervention.
The second visual is a scalpel with an arrow pointing downwards, and copy says >50% reduction in secondary surgical intervention.

Greater than 50% relative reduction in incisional SSIs‡ for Hydrus® Microstent patients compared to cataract surgery alone1

 

(2.4% in Hydrus® + CS vs. 5.3% in CS only)

The third visual is a shield with a cross, and copy says proven safety at 60 months.
The third visual is a shield with a cross, and copy says proven safety at 60 months.

Outstanding long-term safety at 60 months with SAE** rates comparable to cataract surgery alone1,2

View Clinical Data

Hydrus® Microstent provides confident and efficient microstent delivery

 

Hydrus® Microstent’s intuitive delivery system allows for a straightforward procedure with immediate visual confirmation of successful implantation.

*In the 2020 American Academy of Ophthalmology (AAO) Primary Open-Angle Glaucoma Preferred Practice Pattern guidelines, the Hydrus® Microstent received a data rating of “moderate quality, strong recommendation”; the highest rating given among all MIGS

†n=308 Hydrus® + CS

‡Secondary Surgical Intervention (SSI) includes trabeculectomy, tube shunt, gel stent, ECP/TSCP, non-penetrating; (9/369 Hydrus® and 10/187 CS)

**SAE= Serious Adverse Event; (13/369 (3.5%) in Hydrus® eyes vs. 8/187 (4.3%) in the control eyes)

 
 

An Innovative Design and a Unique Mechanism of Action

Roughly the size of an eyelash, the Hydrus® Microstent is a revolutionary canal-based MIGS device for adult patients with mild to moderate primary open-angle glaucoma. 

 

The device is made of nitinol, which is highly flexible and biocompatible.5

An image of the Hydrus Microstent device appears over a light-blue background. Numbers one through three appear over the image pointing to different locations on the device.
The first circular image of up-close sections of the Hydrus Microstent device.
The first circular image of up-close sections of the Hydrus Microstent device.
Rounded distal tip for a smooth passage into Schlemm’s canal
The second circular image of up-close sections of the Hydrus Microstent device.
The second circular image of up-close sections of the Hydrus Microstent device.
Open-window scaffold design provides outflow pathways for aqueous
The third circular image of up-close sections of the Hydrus Microstent device.
The third circular image of up-close sections of the Hydrus Microstent device.
Aqueous inlet facilitates flow from anterior chamber to Schlemm’s canal

An up-close image of the Hydrus Microstent implanted in an eye. Dark blue arrows indicate flow travelling through the device. Three circular images numbered one through three point to various locations on the device in the eye. The magnified image in number one indicates a 90º Span, number two indicates Open Scaffold Design, and number three indicates Bypass.

Eye icon

90° Span:

 

The only MIGS implant to span approximately 90° of Schlemm’s canal, ensuring access to collector channels in the nasal region.

 

Eye icon

Open Scaffold Design:

 

The first MIGS device to precisely dilate and scaffold Schlemm’s canal, gently expanding the cross sectional area without obstructing outflow access to collector channel ostia.5

 

Eye icon

Bypass:

 

The Hydrus® Microstent bypasses the trabecular meshwork to restore flow of aqueous from the anterior chamber through the inlet of the microstent into Schlemm’s canal.

 
 

Leading the Way For Evidence-Based Outcomes

The HORIZON Study

 

The largest prospective, randomised, controlled MIGS pivotal trial to date with 556 patients at 38 centers in 9 countries and five years of continuous follow up with 80% retention at year five.6-9

A bar graph indicating the Enrolled US Pivotal Trials for the iStent with 239 randomised patients, CyPass with 505 randomised patients, iStent inject with 505 randomised patients and the Hydrus Microstent with 556 randomised patients.

*Trademarks are the property of their respective owners.

Clinically proven to provide long-term IOP reduction10

Two bar graphs comparing the results of the Hydrus Microstent plus Cataract Surgery and Cataract Surgery Only studies. The first bar graph indicates that 77.2% of eyes achieved a significant reduction in IOP at 2 years compared to cataract surgery alone. The second bar graph indicates that there was a 43% great mean IOP reduction at two years compared to cataract surgery alone.

Clinically proven to provide long-term medication reduction1,6-8*

A line graph comparing the results of the Hydrus Microstent plus Cataract Surgery and Cataract Surgery Only studies. The results indicate that 66% of Hydrus Microstent patients on up to four preoperative medications remained medication-free at 5 years.

 

Image of 59 precent

 

of Hydrus® Microstent patients on up to four preoperative medications remained medication-free at 5 years4

 

Among Hydrus® Microstent Patients on 1 Prior Medication

 

Image of 88 precent

 

remained medication free at 2 years1

 

 

Image of 66 precent

 

remained medication free at 5 years4

 

Through 5 years, incisional SSIs† were low in the Hydrus® group1

A visual indicating the results of the Hydrus Microstent plus Cataract Surgery and Cataract Surgery Only studies. The results indicate a >50% relative reduction in incisional secondary surgical intervention for Hydrus Microstent patients compared to cataract surgery alone.

*5-year pivotal trial follow up included 308 patients in the Hydrus® group and 134 in the control

†Secondary Surgical Intervention (SSI) include trabeculectomy, tube shunt, gel stent, ECP/TSCP, non-penetrating; (9/369 Hydrus® and 10/187 CS) 

Established long-term safety at 60-months with comparable SAE* rates reported vs cataract surgery alone1

image of table long term safety at 60 months

*SAE= Serious Adverse Event; (13/369 (3.5%) in Hydrus® eyes vs. 8/187 (4.3%) in the control eyes)

The COMPARE Study

 

The first prospective, randomised, multicentre trial comparing Hydrus® Microstent vs 2 iStent* Trabecular Micro Bypass implants

 

more Hydrus® Microstent medication-free patients compared to patients with 2 iStent* implants.11

A bar graph comparing the results of Hydrus Microstent vs two iStent Trabecular Micro Bypass implants. The results indicate ~2X more Hydrus Microstent medication-free patients compared with 2 iStent implants.
Text on blue background

 

mean medication reduction at 2 years with Hydrus® Microstent, compared to a 30% reduction in the 2 iStent* group11

Two bar graphs comparing the results of Hydrus Microstent vs two iStent Trabecular Micro Bypass implants. The results highlight a 52% mean medication reduction at 2 years with Hydrus Microstent, compared to a 30% reduction in the 2 iStent group.

*Trademarks are the property of their respective owners.

Using Hydrus® Microstent in Your Practice

Discover Hydrus® Microstent 
Dr. Ike Ahmed Performs Hydrus® Microstent Surgery

Hydrus® Microstent Clinical Studies

Ahmed IIK, et al. Long-term outcomes from the HORIZON randomized trial for a Schlemm’s canal microstent in combination cataract and glaucoma surgery

 

Presenting the 5-year results of the HORIZON trial comparing cataract surgery (CS) combined with an intracanalicular microstent with CS alone
NOTE: Ophthalmology articles are not open-source and require membership.

Samuelson TW, et al. A Schlemm canal microstent for intraocular pressure reduction in primary open-angle glaucoma and cataract: The HORIZON study

 

Comparing cataract surgery with implantation of a Schlemm canal microstent with cataract surgery alone for the reduction of intraocular pressure (IOP) and medication use after 24 months
NOTE: Ophthalmology articles are not open-source and require membership.

Hays CL, et al. Improvement in outflow facility by two novel microinvasive glaucoma surgery implants

 

Determining improvement in outflow facility (C) in human anterior segments implanted with a novel Schlemm's canal scaffold or two trabecular micro-bypasses

Ahmed IIK, et al. A prospective randomized trial comparing Hydrus and iStent microinvasive glaucoma surgery implants for standalone treatment of open-angle glaucoma: The COMPARE study

 

Comparing the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG)
NOTE: Ophthalmology articles are not open-source and require membership.

Otarola F, et al. Ab interno trabecular bypass surgery with Schlemm’s canal microstent (Hydrus) for open angle glaucoma

 

Evaluating the efficacy and safety of ab interno trabecular bypass surgery with the Hydrus microstent in treating people with open angle glaucoma (OAG)

Instructions for Use (IFU)

 

For a full list of indications, contraindications and warnings, please visit ifu.alcon.com and refer to the relevant product’s instructions for use.

Visit IFU Database

Alcon Experience Academy

 

For relevant training content from industry thought leaders

Visit AEA Portal

References:

1. Ahmed IIK, et al. Long-term outcomes from the HORIZON randomized trial for Schlemm’s Canal microstent in combination cataract and glaucoma surgery. Ophthalmology. 2022;129(7):742-751.

2. NIH. Safety & effectiveness study of the Hydrus Microstent for lowering IOP in glaucoma patients undergoing cataract surgery (HORIZON). ClinTrials.gov (NCT01539239).

3. Gedde SJ, et al. Primary open-angle glaucoma preferred practice pattern. Ophthalmology 2020;128(1): 71-150.

4. Alcon Data on File, 2024.

5. Hydrus Microstent Instructions for Use. 2020.

6. US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Glaukos iStent® Trabecular Micro-Bypass Stent. https://www.accessdata.fda.gov/cdrh_docs/pdf8/P080030B.pdf. Published June 25, 2012.

7. US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): CyPass System. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150037B.pdf. Published July 29, 2016.

8. US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): iStent inject Trabecular Micro-Bypass System. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170043b.pdf. Published June 21, 2018.

9. US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): CyPass System. Hydrus Microstent. https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170034B.pdf. Published August 10, 2018.

10. Samuelson TW, Chang DF, Marquis R, et al. A Schlemm canal microstent for intraocular pressure reduction in primary open-angle glaucoma and cataract: The HORIZON Study. Ophthalmology. 2019;126:29-37.

11. Alcon Data on File, 2018.

12. Otarola F, Virgili G, Shah A, et al. Ab interno trabecular bypass surgery with Schlemm ́s canal microstent (Hydrus) for open angle glaucoma. Cochrane Database of Systematic Reviews. 2020;3:CD012740.

 

Please refer to the relevant product direction for use for list of indications, contraindications and warnings.

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