May 1, 2019

Johnson & Johnson Vision to Showcase the Rising Burden of Myopia, New Contact Lens and Surgical Technologies at ARVO Annual Meeting

New Scientific Data Abstracts Slated for Presentation will Address a Range of Eye Health Needs
Features New Study Results for the Company’s Investigational Antihistamine-Releasing Contact Lens
Evaluates TECNIS Eyhance,^ǂ a Next-Generation Monofocal IOL, for Both Monocular and Binocular Vision
Includes First Worldwide Predictive Modelling of Myopia’s Human and Financial Toll

Jacksonville, Fla, and Santa Ana, Calif. May 1, 2019 – Johnson & Johnson Vision will showcase new research abstracts covering topics across a range of eye health needs at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO) in Vancouver, Canada, April 28 - May 2, 2019. Presentations include the first predictive model for direct health and medical costs associated with myopia and related eye conditions around the world, as well as advanced study models that predict new levels of spectacle independence to evaluate intraocular lens (IOL) designs.

Click to Tweet: At #ARVO2019 @JNJVision will showcase data that demonstrates the global impact of myopia and evaluates new contact lens and surgical technologies. https://bit.ly/2HIXDzY

“At ARVO, we’re unveiling new scientific findings across our current product portfolio – ACUVUE, TECNIS Eyhance IOL^ǂ and iDESIGN – as well as our new product pipeline that will help eye care professionals better meet the evolving needs of their patients,” said Xiao-Yu Song, PhD, MD, Global Head of Research and Development, Johnson & Johnson Vision Care, Inc. “We’re also pioneering health outcomes research in the myopia space so that we can increase understanding of this large-scale issue and continue to work with the eye care professional community and others on new research, treatment, and advocacy strategies.”

Investigational Antihistamine-Releasing Contact Lens & New Technologies

On the heels of Phase 3 data published in the journal Cornea for the company’s investigational antihistamine releasing contact lens, Pall B. el al. will present findings from an initial evaluation of efficacy with different doses of the antihistamine ketotifen. (“Clinical Trial Evaluating the Reduction of Itch with a Novel Contact Lens and Antihistamine Combination Product,” B0170 Thursday, May 2, 2019, 10:15 AM – 12:00 PM PT, West Exhibition Hall)

Additional contact lens research of note for presentation include:

“UV light-blocking contact lenses prevent UVB-induced DNA and oxidative damage of the limbal stem cell niche, protect against inflammation and maintain putative stem cell phenotype,” Notara M. B0468 Sunday, April 28, 2019 1:00 PM – 2:45 PM PT, West Exhibition Hall
“Ocular Comfort observed with RevitaLens Solution at 45 and 120 minutes,” Mingqi Bai B0446 Thursday, May 2, 2019 8:00 AM – 9:45 AM PT, West Exhibition Hall
“Influence of contact lens material in shielding against atmospheric pollutants,” Popwell B0420 Thursday, May 2, 2019 8:00 AM – 9:45 AM PT, West Exhibition Hall

Cataract & Refractive
Johnson & Johnson Vision is highlighting new data on spectacle independence, visual acuity, and the effect of acrylic material characteristics on stray light performance. Findings on the newly released TECNIS Eyhance^ǂ IOL, in Europe, support preclinical findings that the product provides excellent monocular and binocular 20/20 vision.¹ New data to support pipeline products in the presbyopia-correcting IOL (PCIOL) category will also be revealed.

Data presented by Rosen et al. provides a model to predict rates of spectacle independence from clinical data to evaluate IOL designs. (“Spectacle independence of pseudophakic patients predicted from preclinical data,” Rosen R. B0261 Tuesday, April 30, 2019 11:45 AM – 1:30 PM PT, West Exhibition Hall)
Data presented by Weeber et al. provides an analysis of light scatter between hydrophilic and hydrophobic IOL designs, further supporting the TECNIS platform by reinforcing that the TECNIS hydrophobic lens material is not associated with glistenings,^2-6 which can inhibit patients’ vision. (“Effect of acrylic material characteristics on stray light performance,” Weeber H. B0251 Tuesday, April 30, 2019 11:45 AM – 1:30 PM PT, West Exhibition Hall)
A presentation by Alarcon A. et al. concludes that higher-order aspheric IOLs provided an improvement in intermediate simulated visual acuity and maintained distance image quality comparable to that of an aspheric IOL, independent of the pupil size. This data supports the newly released TECNIS Eyhance^ǂ IOL, in Europe, and reinforces that TECNIS Eyhance IOL allows patients to achieve significantly improved intermediate vision, compared with a standard aspheric monofocal IOL.⁷ (“Refractive technology to improve intermediate vision in monofocal intraocular lenses,” Alarcon A. B0260 Tuesday, April 30, 2019 11:45 AM – 1:30 PM PT, West Exhibition Hall)
Data presented by Canovas et al. provide strong evidence that IOL materials with UV and Violet blocking properties that continue to transmit healthy blue light provide a superior subjective response on several aspects of functional experience and points out to potential reduction in halos when compared to clear lenses with only UV blockers. (“Optical and Visual performance of violet blocking intraocular lenses,” Canovas C. B0264 Tuesday, April 30, 2019 11:45 AM – 1:30 PM PT, West Exhibition Hall)

Additionally, a presentation by Neal D. et al. (“Objective determination of visual acuity from a single wavefront measurement,” Neal D. B0082 Sunday, April 28, 2019 1:00 PM – 2:45 PM PT, West Exhibition Hall), will connect objective measurements of the eye, used for wavefront-guided, data-driven personalized refractive surgery, with visual acuity as a primary subjective measure of ocular performance. This provides further evidence on how the new iDESIGN Refractive Studio System can be used for diagnosis and treatment in refractive surgery. iDESIGN Refractive Studio is the only system to use topography-integrated, wavefront-guided technology⁸ enabling data-driven personalization; this combination allows surgeons to measure and treat better.

Myopia Health Outcomes & Treatment Insights

Three abstracts on myopia point to the need for evidence-based treatment criteria and new solutions to address this growing global health threat.

In a new, landmark health outcomes analysis, Holy CE et al. project the future human, financial and societal costs from myopia, demonstrating they are significantly underestimated around the world. (“Predicting Costs and Disability from the Myopia Epidemic – A Worldwide Economic and Social Model,” Holy CE. B0357 Wednesday, May 1, 2019 3:00 PM – 4:45 PM PT, West Exhibition Hall)
In two separate analyses, researchers evaluated current treatment interventions to provide more clarity and evidence-based guidance for interpreting and measuring efficacy in myopia. (“Myopia control intervention produces an absolute, rather than a relative, treatment effect across the progression range,” Brennan N. A0060 Wednesday, May 1, 2019 8:15 AM – 10:00 AM PT, West Exhibition Hall and “Modelling of cumulative treatment efficacy in myopia progression interventions,” Cheng X. A0061 Wednesday, May 1, 8:15 AM – 10:00 AM PT, West Exhibition Hall)

1. Data on File, Johnson & Johnson Surgical Vision, Inc. 2018. DOF2018CT4015.

2. Data on File. Johnson & Johnson Surgical Vision, Inc. 2013.

3. Nagata M, Matsushima H, Mukai K, Terauchi W, Senoo T, Wada H, Yoshida S. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. J Cataract Refract Surg. 2010;36(12):2056-2060.
4. Christiansen G, et al. Glistenings in the AcrySof® intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27(5):728-733.
5. Colin J, et al. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. J Cataract Refract Surg. 2012;38(7):1140-1146.
6. Gunenc U, et al. Effects on visual function of glistenings and folding marks in AcrySof® intraocular lenses. J Cataract Refract Surg. 2001;27(10):1611-1614.

7. Based on a clinical study, N= 134 achieved mean 20/20 monocular pooled distance BCDVA Data on File, Johnson & Johnson Surgical Vision, Inc. 2018. DOF2018CT4015.

8. iDESIGN Refractive Studio treatment calculations are made using wavefront measurements, and use either measured topography or keratometry for propagating the wavefront and compensating for the cosine effect (peripheral loss of laser energy due to corneal curvature)

ǂ TECNIS Eyhance IOL has European CE Mark approval and is now commercially available across Europe. This product is not currently approved or commercially available in other countries. The TECNIS Eyehance IOL is not licensed in accordance with Canadian law.

Johnson & Johnson Vision

At Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies,* we have a bold ambition: to change the trajectory of eye health around the world. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better and live better. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

About Johnson & Johnson Medical Devices Companies

As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life.

*Comprising the surgery, orthopaedics, vision and interventional solutions businesses within the Johnson & Johnson’s Medical Devices segment

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Important Information for Contact Lens Wearers: ACUVUE Brand Contact Lenses are only available by prescription for vision correction as a daily wear lens with two-week recommended replacement. An eye care professional will determine whether contact lenses are right for you. Although rare, serious eye problems can develop while wearing contact lenses. To help avoid these problems, follow the wear and replacement schedule and lens care instructions provided by your eye doctor. Do not wear contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. If one of these conditions occurs, remove the lens and contact your eye doctor

immediately. For more information on proper wear, care and safety, talk to your eye care professional and ask for a Patient Instruction Guide, call 1-800-843-2020 or visit Acuvue.com.

About TECNIS Eyhance IOL

Indications for Use

The TECNIS Eyhance IOL, model ICB00, is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens extends the depth of focus, which improves vision for intermediate tasks, and provide similar distance vision as compared to a standard aspheric monofocal IOL. The lens is indicated for placement in the capsular bag only.

General Adverse Events for IOLs

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent iritis, persistent raised IOP (intraocular pressure) requiring treatment, acute corneal decompensation, secondary intraocular surgical intervention (including implant repositioning, removal, AC tap performed later then one week after cataract surgery, or other surgical procedure), and any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment.

ATTENTION: Reference the Directions for Use for Important Safety Information

INDICATIONS AND IMPORTANT SAFETY INFORMATION STAR S4 IR^® LASER, THE iDESIGN^® REFRACTIVE STUDIO AND THE iDESIGN^®ADVANCED WAVESCAN STUDIO SYSTEM

Indications for Use

The STAR S4 IR^® Excimer Laser System and the iDESIGN^®Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision, with myopic astigmatism, up to -6.00 D spherical equivalent as measured by iDESIGN^® Refractive Studio, with cylinder up to -3.00 D, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^® Refractive Studio refraction as follows: Spherical equivalent: Magnitude of the difference is less than 0.625 D, Cylinder: Magnitude of the difference is less than or equal to 0.50 D, Cylinder Axis: If either the manifest cylinder, entered into the iDESIGN^®Refractive Studio, or the iDESIGN^® Refractive Studio cylinder selected for treatment is less than 0.50 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.50 D, the axis tolerance is linearly reduced from 15° (0.5 D) to 7.5° (7.0 D or greater) based on the average magnitude of both cylinders. With documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and with a successful preoperative trial of monovision or history of monovision experience. The STAR S4 IR^® Excimer Laser System and iDESIGN^® Advanced WaveScan StudioSystem/iDESIGN^® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: With hyperopia with and without astigmatism as measured by iDESIGN^® Advanced WaveScan Studio System/iDESIGN^®Refractive Studio up to +4.00 D spherical equivalent, with up to 2.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^®Advanced WaveScan Studio System/iDESIGN^® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D; 18 years of age or older, and with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). The STAR S4 IR^® Excimer Laser System and iDESIGN^®Advanced WaveScan Studio System/iDESIGN^® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with mixed astigmatism as measured by iDESIGN^® Advanced WaveScan Studio System /iDESIGN^® Refractive Studio where the magnitude of cylinder (1.0 D to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 18 years of age or older, and with refractive stability (a change of <1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). The STAR S4 IR^® Excimer Laser System and iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: with myopia as measured by iDESIGN^® Advanced WaveScan Studio System/iDESIGN^®Refractive Studio up to -11.00 D spherical equivalent, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN^® Advanced WaveScan Studio System/iDESIGN^® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D. Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 18 years of age or older, and with refractive stability (a change of <1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery). STAR S4 IR^®Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System.The STAR S4 IR^® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^®System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism from -6.00 to -11.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR^® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of myopia and myopic astigmatism up to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.50D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR^® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of hyperopia and hyperopic astigmatism up to 3.00 D MRSE, with cylinder between 0.00 and 2.00 D; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination. The STAR S4 IR^® Excimer Laser System with Variable Spot Scanning (VSS) and the WaveScan Wavefront^® System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK): for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of cylinder (from 1 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; in patients 21 years of age or older; and in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination.

Conventional LASIK procedure using the STAR S4 IR^® Excimer Laser System

Laser assisted in situ keratomileusis (LASIK) procedure using the STAR S4 IR^® Excimer Laser System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -14.0 D with or without refractive astigmatism from 0.5 to 5.0D*; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with or without refractive astigmatism up to +3.0 D, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. In patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring mixed astigmatism where the magnitude of cylinder (£6.0 D at the spectacle plane) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs.

Conventional PRK procedure using the STAR S4 IR^®Excimer Laser System

Photorefractive Keratectomy (PRK) procedure using the STAR S4 IR^® Excimer Laser System is intended for use: in patients with documented evidence of a change in manifest refraction of no more than 0.5 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -6.0 D spherical equivalent at the corneal plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) of no more than -12.0 D spherical myopia at the spectacle plane with no more than 4.0 D of refractive astigmatism1; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +1.0 and +6.0 D sphere at the spectacle plane, with no more than 1.0 D of refractive astigmatism; or in patients 21 years of age or older in treatments for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with refractive astigmatism from +0.5 to +4.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D.

Contraindications

Laser refractive surgery is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients with corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea; in patients with symptoms of significant dry eyes. If the patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma; in patients with advanced glaucoma; in patients with uncontrolled diabetes; in patients with documented evidence of a change in manifest refraction of more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. in patients taking medications with ocular side effects. Examples are Isotretinoin (Accutane^®) for acne treatment or Amiodarone hydrochloride (Cordarone^®) for normalizing heart rhythm.

Warnings

LASIK is not recommended in patients who have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status; have a history of Herpes simplex or Herpes zoster keratitis; have severe allergies or tendency rub their eyes often; have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect); are taking the medication Isotretinoin (Accutane);are taking antimetabolites for any medical conditions.

Precautions:

To reduce the risk of corneal ectasia, the posterior 250 microns (µm) of corneal stroma should not be violated. Please refer to Operator’s Manual for a list of additional Precautions

Adverse Events:

Prior clinical study of monovision LASIK using the WaveScan Wavefront^® System aberrometer, supports the safety and effectiveness of iDESIGN^® driven Monovision LASIK Treatment. Please refer to Operator’s Manual for a list of Adverse Events and complications in clinical studies for Monovision in Presbyopic Patients with Low to Moderate Myopia and Myopic Astigmatism, Myopia, Mixed Astigmatism and Hyperopia.

LASIK label
Rx Only

1 Caution must be used to calculate treatment in MINUS CYLINDER at the spectacle plane (vertex distance 12.5 mm) before entering the refraction into the laser in order to conform with the Indications for Use.

Caution - Class 4 Laser Product

ACUVUE is a registered trademark of Johnson & Johnson Vision Care, Inc.

For further information, contact:

Angela Sekston

904-868-4198 (mobile)

asekston@its.jnj.com

Allie Holmes

949-244-7012 (mobile)
Aholmes1@its.jnj.com

GCC19150 / PP2019CT4489