CHARTING THE NEW COURSE FOR MIGS

Transcription

1 CHARTING THE NEW COURSE FOR MIGS SEE WHAT S ON THE HORIZON CyPass Micro-Stent the next wave in micro-invasive glaucoma surgery.

2 MICRO-INVASIVE GLAUCOMA SURGERY (MIGS) OFFERS A REVOLUTIONARY APPROACH TO THE TREATMENT OF GLAUCOMA Glaucoma is a leading cause of irreversible blindness, affecting approximately 60 million people worldwide 1 Approximately 20% of the annual cataract surgeries in the United States are in patients with comorbid glaucoma 2 Cataract surgery alone has been shown to lower IOP 3,4 Implanted at the time of cataract surgery, the CyPass Micro-Stent lowers IOP better than cataract surgery alone in more of your patients 5 For Important Product Information, please see page 7.

3 INTRODUCING THE FUTURE OF MICRO-INVASIVE GLAUCOMA SURGERY: THE CYPASS MICRO-STENT OPTIMIZED DESIGN GUIDEWIRE TUBE DIAMETER: 630 µm 3 RETENTION RINGS 64 FENESTRATIONS OUTER DIAMETER: INNER DIAMETER: 510 µm 310 µm The CyPass Micro-Stent is a fenestrated microstent made of biocompatible polyimide material Inserted into the supraciliary space, the CyPass Micro-Stent enables aqueous drainage through the uveoscleral pathway 6.35 mm MRI S A F E The unique design creates tenting in the supraciliary space upon insertion to enhance aqueous outflow 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. ENHANCED AQUEOUS OUTFLOW The supraciliary space has a negative pressure gradient that drives aqueous outflow and reduction of intraocular pressure 6 The uveoscleral pathway bypasses Schlemm s canal and collector channels, which may be atrophic in glaucoma patients 7 The CyPass Micro-Stent utilizes the same outflow pathway as first line prostaglandin analogues 8

4 CYPASS MICRO-STENT DELIVERS SUPERIOR, LONG-TERM IOP-LOWERING EFFICACY TWO-YEAR COMPASS TRIAL IS THE LARGEST MIGS RANDOMIZED CONTROLLED TRIAL COMPLETED TO DATE Landmark FDA study with two-year follow-up on >500 patients with baseline/terminal washout 100.0% 100.0% Percent of Eyes 80.0% 60.0% 40.0% +14.5% 72.5% ** 58.0% Percent of Eyes 80.0% 60.0% 40.0% 61.2% ** +17.7% 43.5% 20.0% 20.0% 0.0% **p= M 0.0% **p= M CyPass Micro-Stent + Cataract surgery (n=374) Cataract surgery (n=131) 72.5% of eyes achieved 20% reduction in unmedicated diurnal IOP at 2 years* 61.2% of eyes maintained an unmedicated diurnal IOP range between 6 and 18 mmhg at 24 months (a 41% increase)* *Prospective, randomized, multicenter clinical trial in patients (n=505) with open-angle glaucoma undergoing cataract surgery randomized to microstent (n=374) or phacoemulsification (n=131). Primary outcome measure was unmedicated diurnal IOP reduction at 24 months versus cataract surgery alone at baseline. Secondary outcomes measures included mean change in 24 month DIOP from baseline and 24 month unmedicated mean IOP (between 6 mmhg to 18 mmhg) versus cataract surgery alone. Medication use at 24 months was also analyzed. The primary and secondary effectiveness analyses were performed using intent to treat (ITT) population. For Important Product Information, please see page 7.

5 CYPASS MICRO-STENT MAINTAINS A HEALTHY IOP RANGE FOR MORE PATIENTS THAN CATARACT SURGERY ALONE mmhg ** % Percent of Patients 100.0% 80.0% 60.0% 40.0% 20.0% 93.0% +20.6% 72.4% -12 **p< M 0.0% 24M CyPass Micro-Stent + Cataract surgery (n=374) Cataract surgery (n=131) CyPass Micro-Stent eyes achieved a nearly 2 mmhg additional mean unmedicated diurnal IOP reduction from baseline (32% more effective than cataract surgery alone)* Of responders, 93% in the CyPass Micro-Stent group were medication-free at 24 months* Those patients who attained an unmedicated mean diurnal IOP reduction of 20% or more as compared with baseline in the absence of IOP-affecting surgery during the study *Prospective, randomized, multicenter clinical trial in patients (n=505) with open-angle glaucoma undergoing cataract surgery randomized to microstent (n=374) or phacoemulsification (n=131). Primary outcome measure was unmedicated diurnal IOP reduction at 24 months versus cataract surgery alone at baseline. Secondary outcomes measures included mean change in 24 month DIOP from baseline and 24 month unmedicated mean IOP (between 6 mmhg to 18 mmhg) versus cataract surgery alone. Medication use at 24 months was also analyzed. The primary and secondary effectiveness analyses were performed using intent to treat (ITT) population.

6 CYPASS MICRO-STENT SYSTEM OFFERS A MINIMALLY INVASIVE, INTUITIVE IMPLANTATION APPROACH The procedure is ab-interno, using the primary clear corneal incision made at the time of cataract surgery. Proximal rings, clearly visible under a gonioscopy lens, provide guidance for proper insertion and depth. The CyPass Micro-Stent is minimally invasive, spares the conjuctiva, and avoids the formation of a filtering bleb. For Important Product Information, please see page 7.

7 CYPASS MICRO-STENT IMPORTANT PRODUCT INFORMATION CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN INDICATION: The CyPass Micro-Stent 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 Micro-Stent 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. 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 Micro-Stent 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 the CyPass Micro-Stent 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 INSTRUCTIONS FOR A COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS.

8 CYPASS MICRO-STENT OFFERS YOU THE OPPORTUNITY TO SAFELY AND EFFECTIVELY ACHIEVE A HEALTHY IOP RANGE OPTIMIZED DESIGN The CyPass Micro-Stent is a fenestrated microstent made of biocompatible polyimide material The unique design creates tenting in the supraciliary space upon insertion to enhance aqueous outflow The uveoscleral pathway bypasses Schlemm s canal and collector channels, which may be atrophic in glaucoma patients 6 INTUITIVE IMPLANTATION APPROACH Ab-interno insertion through the clear corneal incision Proximal rings clearly visible to guide surgeon throughout implantation process SUPERIOR AND LONG-TERM EFFICACY 72.5% of eyes treated with the CyPass Micro-Stent achieved a greater than 20% reduction in IOP at 2 years vs. only 58% with cataract surgery alone % of eyes treated with the CyPass Micro-Stent maintained unmedicated diurnal IOP between 6 and 18 mmhg at 2 years vs. only 43.5% with cataract surgery alone 5 93% of responders were medication-free at 2 years vs. only 72% of patients with cataract surgery alone 5 TWO-YEAR COMPASS TRIAL The landmark FDA study with two-year follow-up on more than 500 patients with baseline and terminal washout Largest randomized, controlled MIGS study to date 1. Tham Y, Hons B, Li X, et al. Global prevalence of glaucoma and projections of glaucoma burden through Ophthalmology. 2014;121: Tseng VL, Yu F, Lum F, Coleman AL. Risk of fractures following cataract surgery in Medicare beneficiaries. JAMA 2012;308: Vold S, Ahmed I, Craven E, et al. Two-year COMPASS trial results: Supraciliary microstenting with phacoemulsification in patients with open-angle glaucoma and cataracts. Ophthalmology. 2016; Vizzeri G, Weinreb RN. Cataract surgery and glaucoma. Curr Opin Ophthalmol 2010;21: CyPass Micro-Stent Instructions for Use. 6. Saheb H, Ianchulev T, Ahmed I. Optical coherence tomography of the suprachoroid after CyPass Micro-Stent implantation for the treatment of open-angle glaucoma. Br J Ophthalmol. 2012;98: Fellman R. Episcleral venous fluid wave correlates with the type and extent of canal based surgery. AGS Abstract Weinreb R, Toris C, Gabelt B, et al. Effects of prostaglandins on the aqueous humor outflow pathways. Surv Ophthalmol. 2002;47(Suppl 1):S53 S Novartis 10/16 US-CYP-16-E-3346