and done ONE CYPASS MICRO-STENT IS ALL IT TAKES TO DELIVER ON THE PROMISE OF MIGS SAFE, CONSISTENT, LONG-TERM IOP CONTROL

Transcription

1 FOR THE REDUCTION OF IOP IN MILD TO MODERATE PRIMARY OPEN-ANGLE GLAUCOMA AT THE TIME OF CATARACT SURGERY and done ONE CYPASS MICRO-STENT IS ALL IT TAKES TO DELIVER ON THE PROMISE OF MIGS SAFE, CONSISTENT, LONG-TERM IOP CONTROL

2 Daily topical glaucoma medication can be burdensome for patients PATIENTS FACE A VARIETY OF CHALLENGES THAT CAN LIMIT THE EFFECTIVENESS OF TOPICAL TREATMENT, INCLUDING1: Medication cost NEARLY Difficulty with administration 50 % of patients stop administering their topical medication within 6 months2 20 % of patients with cataracts also have glaucoma, and many can benefit from a combined surgical procedure with benefits that may include reduction of dependency on topical medication3,4 ABOUT 2 Forgetfulness

3 ONLY CYPASS MICRO-STENT DELIVERS* Superior, consistent, long-term IOP control with a single stent GREATER THAN 70% OF EYES TREATED WITH CYPASS MICRO-STENT ACHIEVED A 20% REDUCTION IN UNMEDICATED IOP AT TWO YEARS5 100% p= Percent of eyes 80% +14.5% 72.5% 60% 58% 40% 20% 0% CyPass Micro-Stent + cataract surgery (n=374) Cataract surgery alone (n=131) GREATER THAN 60% OF EYES TREATED WITH CYPASS MICRO-STENT MAINTAINED UNMEDICATED IOP BETWEEN 6 mmhg AND 18 mmhg AT TWO YEARS5 100% p= Percent of eyes 80% 60% 61.2% +17.7% 40% 43.5% 20% 0% CyPass Micro-Stent + cataract surgery (n=374) Cataract surgery alone (n=131) 3

4 ONLY CYPASS MICRO-STENT DELIVERS* IOP lowering without compromising the safety of cataract surgery 32% MORE EFFECTIVE AT IOP LOWERING THAN CATARACT SURGERY ALONE 5 CyPass Micro-Stent + cataract surgery (n=374) Cataract surgery alone (n=131) p< mmhg % Months UNPARALLELED MEDICATION REDUCTION FOR MORE PATIENTS 93% OF RESPONDERS WERE MEDICATION FREE AT TWO YEARS 5 Study design: Prospective, randomized, multicenter clinical trial in patients (N=505) with open-angle glaucoma undergoing cataract surgery. Patients were randomized to receive phacoemulsification and CyPass Micro-Stent implantation (n=374) or phacoemulsification alone (n=131), and all patients were followed for two years. The primary outcome measure was the proportion of eyes with unmedicated diurnal IOP reduction 20% at two years vs unmedicated baseline IOP. Secondary outcome measures included mean change in 24-month diurnal IOP from baseline and 24-month unmedicated mean IOP (between 6 mmhg and 18 mmhg) vs cataract surgery alone. Medication use at 24 months was also analyzed. The primary and secondary effectiveness analyses were performed using the intent-to-treat (ITT) population.4 Those patients who attained an unmedicated mean diurnal IOP reduction of 20% or more as compared to baseline in the absence of IOP-affecting surgery during the study. Percentage vs 72.4% of patients who were treated with cataract surgery alone.5 4

5 ONLY CYPASS MICRO-STENT DELIVERS* Enhanced outflow via the proven uveoscleral pathway MAXIMIZED FROM THE ANTERIOR CHAMBER TO THE SUPRACILIARY SPACE5 UNRESTRICTED SPACE MINIMAL RESISTANCE ACTIVE PRESSURE GRADIENT 360 access to the area independent of selectively located collector channels6,7 Outflow bypasses Schlemm s canal, and the collector channels, which may be atrophic in glaucomatous eyes8,9 The 3 mmhg to 4 mmhg difference in natural pressure between the anterior chamber and the supraciliary space acts as a driving force for aqueous outflow10 CYPASS MICRO-STENT IS THE FIRST AND ONLY MIGS DEVICE TO TARGET THE SUPRACILIARY SPACE4,5 SUPRACILIARY SPACE SCHLEMM S CANAL SUBCONJUNCTIVAL SPACE CYPASS MICRO-STENT5 istent11ii XEN GEL12II Trademarks are the property of their respective owners. ll 5

6 ONLY CYPASS MICRO-STENT DELIVERS* Optimal performance with a smart design FLEXIBLE Device curves along guidewire during insertion and straightens once placed, creating a tenting effect4 COLLAR (530 μm) OPTIMIZED 6.35 mm length leverages the eye s negative pressure gradient5 ENHANCED 64 fenestrations help to maximize aqueous outflow4,5 3 RETENTION RINGS (510 μm) 64 FENESTRATIONS OUTER DIAMETER (430 μm) MRI SAFE 6.35 mm INNER DIAMETER (300 μm) CyPass Micro-Stent is magnetic resonance (MR) safe: the implant is constructed of polyimide material; a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic resonance imaging environments.5 6 SCALED TO SIZE IMPORTANT PRODUCT INFORMATION CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN INDICATION: The CyPass Ultra System 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: Use of the CyPass Ultra System is contraindicated in 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 angle.

7 Only CyPass Micro-Stent leverages an intuitive implantation approach A b-interno implantation uses the same clear corneal incision made at the time of cataract surgery4 Curved guidewire allows you to work in harmony with the eye s anatomy4,5 A traumatic, beveled guidewire tip allows you to carefully dissect the scleral spur and ciliary body5 TED I N TH I E M AN PL SELF-LOCATING SUPRACILIARY SPACE During implantation, the scleral wall serves as a tactile guide allowing CyPass Micro-Stent to self-locate into the correct position5 IMPORTANT PRODUCT INFORMATION (CONTINUED) MRI INFORMATION: The CyPass Micro-Stent is magnetic resonance (MR) safe: the implant is constructed of polyimide material, a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic resonance imaging environments. WARNINGS: Gonioscopy should be performed prior to surgery to exclude peripheral anterior synechiae (PAS), rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. PRECAUTIONS: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the CyPass Ultra System has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, in eyes with significant prior trauma, chronic inflammation, eyes with an abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, pseudophakic eyes with glaucoma, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open-angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes with laser trabeculoplasty performed 3 months prior to the surgical screening visit, eyes with unmedicated IOP less than 21 mmhg or greater than 33 mmhg, eyes with medicated IOP greater than 25 mmhg, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment, and when implantation is without concomitant cataract surgery with IOL implantation for visually significant cataract. The safety and effectiveness of use of more than a single CyPass Micro-Stent has not been established. ADVERSE EVENTS: In a randomized, multicenter clinical trial comparing cataract surgery with the CyPass Micro-Stent to cataract surgery alone, the most common postoperative adverse events included: BCVA loss of 10 or more letters at 3 months after surgery (8.8% for CyPass MicroStent vs. 15.3% for cataract surgery only); anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmhg 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%). ATTENTION: PLEASE REFER TO THE PRODUCT INSTRUCTIONS FOR A COMPLETE LIST OF CONTRAINDICATIONS, 7 WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS.

8 One CyPass Micro-Stent is all it takes to deliver on the promise of MIGS CYPASS MICRO-STENT DELIVERS: SUPERIOR, consistent, long-term IOP control with a single stent* MEDICATION REDUCTION ENHANCED outflow via the proven uveoscleral pathway in the COMPASS trial at two years OPTIMAL performance with a smart design INTUITIVE implantation approach EXPERIENCE THE ONE-OF-A-KIND CYPASS MICRO-STENT: CONNECT WITH YOUR ALCON REPRESENTATIVE TODAY 93% of responders who attained an unmedicated diurnal IOP reduction of 20% or more as compared to baseline in the absence of IOP-affecting surgery during the study. References: 1. Lacey J, Cate H, Broadway DC. Barriers to adherence with glaucoma medications: a qualitative research study. Eye (Lond). 2009;23(4): Nordstrom BL, Friedman DS, Mozaffari E, Quigley HA, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J Ophthalmol. 2005;140(4): Tseng VL, Yu F, Lum F, Coleman AL. Risk of fractures following cataract surgery in Medicare beneficiaries. JAMA. 2012;308(5): Vold S, Ahmed IIK, Craven ER, et al; for the CyPass Study Group. Two-year COMPASS trial results: supraciliary microstenting with phacoemulsification in patients with open-angle glaucoma and cataracts. Ophthalmology. 2016;123(10): CyPass Ultra System Instructions for Use. 6. Kim YC, Edelhauser HF, Prausnitz MR. Targeted delivery of antiglaucoma drugs to the supraciliary space using microneedles. Invest Ophthalmol Vis Sci. 2014;55(11): Gilger BC, Abarca EM, Salmon JH, Patel S. Treatment of acute posterior uveitis in a porcine model by injection of triamcinolone acetonide into the suprachoroidal space using microneedles. Invest Ophthalmol Vis Sci. 2013;54(4): Nilsson SF. The uveoscleral outflow routes. Eye (Lond). 1997;11(Pt 2): Fellman RL, Feuer WJ, Grover DS. Episcleral venous fluid wave correlates with trabectome outcomes: intraoperative evaluation of the trabecular outflow pathway. Ophthalmology. 2015;122(12): Emi K, Pederson JE, Toris CB. Hydrostatic pressure of the suprachoroidal space. Invest Ophthalmol Vis Sci. 1989;30(2): istent Directions for Use. 12. XEN Gel Stent Directions for Use Novartis 03/18 US-CYP-18-E-0407 GETCYPASS.COM