CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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CONTACT LENS INDUSTRY UPDATE WHAT’S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO Associate Dean
CONFLICT OF INTEREST u No conflict of interest – past 12 months u Serve on Editorial Board, Contact Lens Spectrum Journal Indiana University School of Optometry
GOALS u Review contact lens introductions over the last 12 months u Soft contact lenses u GP contact lenses (corneal and scleral) u Review care system introductions / news u Review CL industry news u Discuss “On-line Prescribing” of CL u Review regulatory issues affecting CL - Look at FTC proposed changes to FCLCA Indiana University School of Optometry
CONTACT LENS MARKET u Contact lenses up 5% in US; 4% world u Numbers of fits and wearers constant - Increase in the in the sales or money from CL u ODs said 32% of gross, 27% net from CL u Daily disposables highest growth segment - Nearly 38% of worldwide market share is DD - US closer to 18-20% u SCL sph 54%, toric 25%, multi 13%, corneal GP 4%, scleral GP 4% Indiana University School of Optometry
J&J VISION CARE u Anticipate at least 2 new products @ year until 2022 u Newest products in past 12 months: - Vita Sphere (monthly replacement) u +8 to -12 powers; 8.4 & 8.8 bc; 14.0 diameter - 1-Day Oasys for Astigmatism u pl to -6: -0.75, -1.25, -1.75 cyls ; @ 10 degress -2.25 cyl +/- 20 degrees around 90/180 u -6.50 to -9 & +0.25 to +4: -0.75, -1.25, -1.75 cyl +/- 20, 90/180 - Vita for Astigmatism – same parameters as above Indiana University School of Optometry
COOPER VISION u Introduced the Biofinity Energys - designed for computer and digital device users u Avaira Vitality sphere; Avaira Vitality Toric - slightly modified material from Avaira u Clarity 1 Day Toric - extended the range of parameters - introduced 90 packs (last of Clarity 1 Day line to have) u Biofinity Toric XR - custom 6 packs in high cyls; long awaited Indiana University School of Optometry
COOPER VISION MY DAY TORIC u Silicone-hydrogel daily disposable lens u Same material as MyDay sphere u Same toric design as the Biofinity Toric u Would now be the highest oxygen transmission of any DD toric Indiana University School of Optometry
COOPER VISION ANNOUNCED DISCONTINUATIONS u Biomedics XC Nov 2017 u ClearSight 1 day toric Nov 2017 u Vertex Toric XR Jan 2018 u Avaira sphere May 2018 u Avaira toric Jan 2018 u Frequency 55 toric Nov 2018 u Frequency 55 toric XR Nov 2018 - trials for all end from Feb 2017 to Nov 2017 u ClearSight 1 day; Proclear 1 day; Proclear 1 day multifocal – all discontinue sale of 30 pack size by November 1, 2018 Indiana University School of Optometry
ALCON u Air Optix Plus - Same exact parameters as regular Air Optix Aqua - Same material, but added Hydraglyde to the lens and package u Alcon Dailies Total 1 multifocal - Same multifocal design as Air Optix & Dailies multifocals - 3 add powers/center near design - Expanded parameters: +6 to -10 Indiana University School of Optometry
BAUSCH + LOMB u Ultra for Presbyopia u & Biotrue for Presbyopia - same 3-zone progressive design as other B+L multifocals - low and high add options - center distance design u Ultra for Astigmatism - similar design as PureVision 2 for astigmatism - expanded parameters (+6 to –9; 4 cyls @ 10 degrees) u Biotrue for Astigmatism 1-day - orientation mark at 6 o’clock - also small mark at axis location - peri-ballasted, so no prism in optics Indiana University School of Optometry
MENICON u Menicon introduced Miru Monthly - 8.3/8.6; 14.0; +6.00 to -13 - Similar oxygen to other SiHy monthly lenses u Miru Daily Disposable - Added a second base curve - 8.4 (had 8.6 only) u RoseK2 Soft Lenses - 4 packs of lenses; aspheric back, toric front optics - Availale initially from ABB and Art Optical in US Indiana University School of Optometry
VISIONEERING TECHNOLOGIES u Introduced NaturalVue Multifocal 1-Day last year (Center Distance; 1 add) u Just announced a NaturalVue Sphere 1-Day lens u +4 to -12 sphere powers in 0.25D steps throughout the entire range u Toric & Multifocal Toric DD coming Indiana University School of Optometry
SCLERAL LENS NEWS u Zenlens introduced 28 lens diagnostic set - Added 4 lenses with toric haptic (2 dia; oblate/prolate) u Art Optical has Ample Eye - Scleral with toric periphery standard; & has multifocal u Blanchard - Sym-Toric scleral version of Onefit lenses (front toric) with no prism in the lens, and not toric haptic - Onefit Med – customizable for highly irregular, medically indicated corneas (15.6, 16.0, 16.4 dia) - Onefit A – introduced for Asian eyes Indiana University School of Optometry
SCLERAL LENS NEWS u SynergEyes – introduced a scleral CL - SynergEyes VS Scleral - toric periphery; independent parameter adjustments - Menicon Z for highest oxygen; 16 lens fitting set u X-Cel - Atlantis multifocal (center-distance design, & zone size can be controlled - Atlantis 3D-Vault with limbal control technology u can adjust limbal sag apex; can utilize standard set to begin Indiana University School of Optometry
TANGIBLE HYDRA-PEG u A treatment to the lens surface that enhances wetting, resists deposits u Being marketed by Contamac u Can be applied to all their materials u Corneal GPs; sclerals; Synergeyes hybrids u Recommend Unique pH or ClearCare u 1 year warranty from some labs u $15-25 cost to add it, typically 12/17/17 Indiana University School of Optometry
MYOPIA: STOP CORRECTING & START CONTROLLING? Where Are We Along the Myopia Treatment Continuum? Correcting Controlling Preventing Where Are You? Indiana University School of Optometry
MYOPIA STATISTICS u US myopia in 1907 was 25% u US myopia today is 42% u 9.6 million in US are severely myopic - 4% of US population (-6.00D and above) u 41,000 suffer myopic macular degen. - Rate of myopic complications is nearly 2x for women Willis et al. The Prevalence of Myopic Choroidal Neovascularization in the United States. Ophthalmology, 2016 DOI: 10.1016/j.ophtha.2016.04.021 Indiana University School of Optometry
MYOPIA STATISTICS u 4 x risk of RD if -1 to -3 vs. emmetrope u Goes to as high as 10 x for over -5.00D u Increased risk for glaucoma is 1.65 x up to -3.00D, and 2.46 x if over -3.00D u 25% incidence of myopic maculopathy if over -5.00D u 52% incidence if over -9.00D Indiana University School of Optometry
MYOPIC RISK FACTORS
IF LESSENING, BUT NOT ELIMINATING THE MYOPIA – WHY DOES IT MATTER? u If can reduce myopic progression by: - 33%, (seen in most all studies), will reduce the number of High Myopes (>5D) by 70% - 50%, will reduce high myopia by 90% from Noel Brennan u Consider the lifetime risk of high myopia (RD; myopic macula effects) to the risk of getting a CL related corneal ulcer - Risk for a -4D to -6D myope 6x the risk of an ulcer Indiana University School of Optometry
MYOPIA PROGRESSION: ENVIRONMENTAL EFFECTS u Effects of bright light
EYE GROWTH AND PERIPHERAL RX u Retinal processing – 90% of retinal ganglion cells are found outside the fovea (Azzopardi and Cowey, Neuroscience ,1996) u Off-axis refraction may be more or less hyperopic or myopic in the periphery u Myopes have more relative peripheral hyperopia (Mutti, IOVS, 2000; Millodot, OPO, 1981) u Increase this with most myopic corrections 12/17/17 Indiana University School of Optometry
“CREATE A MYOPIC DEFOCUS OVER A LARGE AREA OF THE RETINA” - EARL SMITH 12/17/17 Indiana University School of Optometry
MYOPIA CONTROL OPTIONS
EXPECTED EFFECT ON PROGRESSION u Studies using soft multifocal contact lenses tend to reduce myopic progression in the 33-40% range u OK studies commonly have effects in the 40-50% range reduction u Atropine has shown the ability to slow progression in the 45-70% range Indiana University School of Optometry
ATROPINE STUDIES – ATOM; ATOM2 12/17/17 Indiana University School of Optometry
MYOPIA CONTROL u Brien Holden Vision Institute has a Myopia Calculator online - Enter age, Rx, and shows expected effect of various treatment options on the final myopic correction - https://calculator.brienholdenvision.org u Paragon has videos and resources for discussing myopia control with parents u Where are you when it comes to myopia? Controlling progression or contributing to it?
WHAT’S NEW WITH SOLUTIONS? u 2 products have now been introduced for filling the bowl of scleral contact lenses u LacriPure from Menicon u ScleralFil from B+L Specialty Indiana University School of Optometry
CLEAR CARE PRODUCTS u ClearCare Plus with Hydraglyde - wetting agent added u ClearCare Rinse & Go - saline product to rinse after soaking or if drop lens Indiana University School of Optometry
PEROXICLEAR BY B+L u Taken off the market, at least for a time u Some patient reports of irritation upon insertion in the morning u Was approved for a 4 hour minimum soak - wanted this for mainly a marketing claim of “fastest” u This may not be enough time for everyone - leaves some residue (50-100 parts/ million) u No damage to eyes caused by this u Was a voluntary recall; future unknown Indiana University School of Optometry
INDUSTRY MERGERS – J&JVC u J&J Vision Care purchased AMO - Mainly adds an ophthalmic surgical business that J&J did not have any role in before - Believe the surgical side will remain much as it is – as a division on it’s own - Contact lens care business will likely be absorbed by other J&JVC divisions u gives an entry into the solution market u OxySept, Revitalens for SCL; Total for GP u Revitalens now being marketed as “Blink Revitalens” 12/17/17 Indiana University School of Optometry
INDUSTRY MERGERS – J&JVC u J&J Vision Care purchased TearScience - Lipiscan & Lipiview diagnostic instruments - Lipiflow treatment device - Indiana University School of Optometry
INDUSTRY MERGERS – J&JVC u J&J Vision Care purchased Sightbox u Sightbox is an online contact lens direct to consumer subscription service u Allows patient to make monthly payments on their yearly supply of CL u In 2016, estimated that 18% of contact lens purchases were sold on line u Why does J&JVC want to get into direct to consumer sales? Indiana University School of Optometry
J&JVC STATED GOALS FOR SIGHTBOX PURCHASE u Online purchases are lost to professional offices, and not going to go back u Want to disrupt the “renewals”, and send them back to the doctor - Hope is they might then be fit in updated lenses - Sightbox will contact doctor, and agree to pay them a “usual & customary” exam and CL services fee - Doctor then gives the CL Rx to Sightbox - Patient expects to pay $0 at their visit u Contend if patient not happy, will go to an online exam and CL Rx next time Indiana University School of Optometry
INDUSTRY MERGERS u CooperVision purchased Procornea - Netherlands based specialty CL manufacturer - Adds the DreamLite orthokeratolgy lenses - Believed to fit in with CV efforts in the area of myopia control - Lab and offices to remain in Europe u CooperVision purchasing Paragon Vision Sciences - The CRT lenses fit with the myopia control emphasis - Also gives CV a family of GP materials and GP button manufacturing capability Indiana University School of Optometry
OTHER INDUSTRY NEWS u Alcon - Added AlconODMarketing.com u A site to assist ODs with their digital media marketing - Heavy rebate program to encourage daily disposables u $200 rebates to make it more affordable & attractive - Changed packaging on Air Optix Aqua u Added insertion and removal instructions u J&JVC - Heavy effort into advocacy support u Vision to Action site; Advocacy Academy site with many resources to help with advocacy Indiana University School of Optometry
OTHER INDUSTRY NEWS u B+L - #ONEbyONE recycling program (with Terra Cycle) u In office, and patients can download shipping lables - Close to EW approval for Ultra material u B+L Specialty Vision - FDA approval for Therapeutic use of Boston XO/XO2 u May see scleral lens products developed to utilize this - Offer Boston materials guarantee u 6 months, if not 100% satisfied (wetting; breaking), replace u Contamc - FDA approval for HEXA 100 material,& with HydraPeg Indiana University School of Optometry
GPLI RESOURCES u gpli.info u Much new information u Fitting programs u Medical CL billing information u Case examples u Staff training modules u Searchable lens database u Much more Indiana University School of Optometry
12/17/17 Indiana University School of Optometry
SCLERAL LENS SOCIETY u Offering educational opportunities u Excellent lectures and workshops u Resources available on their site u Big presence at the GSLS @ January (Global Specialty Lens Symposium) u Scleral workshops and numerous lectures at the Am. Academy meeting in San Antonio in November Indiana University School of Optometry
CL INDUSTRY DATA u 38% of CL are sold by OD, OMD office u 19% by retail chains (Lenscrafter; Pearle) u 25% by mass marketers (Walmart; Costco; Sam’s Club) u 18% on-line sellers - of these, 2% through distributors for OD offices - 16% by 1-800 and all the others combined u 96% of patients satisfied with their CL purchase options Indiana University School of Optometry
NEW ONLINE ACTIVITY u Hubble Contacts – hubblecontacts.com u Their own DD lens u 30$/month subscription u Trying to sign up ODs u Lenses are made by “St. Shine” in Taipei, China u Toric DD coming soon u Not compliant with FCLCA? u Left Harry’s Razors to found Hubble Indiana University School of Optometry
THE BROKEN STATE OF CL VERIFICATION CONTACT LENS SPECTRUM 11/2017
OTHER NEW MARKETERS u Simple Contacts – wear your CL, enter CL data, take an online test u Within 24 hours “World-Class Doctors” will give you a CL Rx - all OMDs in New York and possibly other East Coast u Company received $8 million in venture capitol funding from Notation Capitol extolling this innovative, game-changing technology breakthrough Indiana University School of Optometry
OTHER QUESTIONABLE MARKETERS u VisionPros.com - Advertise “No Prescription Needed” or “Buy your contact lenses without a Dr.” u The Lens Butler – subscription service u Opternative - online refraction and then can purchase a CL Rx also u 1 800 Contacts - many cases documented of changing the type of CL - pushing legislation to make all SCL “generic” Indiana University School of Optometry
HOW DO YOU COMPETE u Have your own subscription service, in addition to ease of ordering from your website u Use friendly services - Lens Ferry S: owned by CooperVision; you control fees; patient can pay monthly and get lenses quarterly u all lenses, not just CV; sign them up before leave office u part of Eye Care Prime; reduced fee based on CV sales - CL Compare – help do annual supply - Lensquote.net – to help promote annual supply - I am sure there are others, but not familiar with Indiana University School of Optometry
OPTERNATIVE u Opternative and 1-800 Contacts u Partnership that has resulted in 1-800 putting greater amounts of money into fighting states that do not allow a CL Rx to be tested for on-line u Most recent laws in Georgia, So. Carolina u IN, MI, AL, MS, Maine, OH, Nebraska all have laws that limit online in some way Indiana University School of Optometry
1-800 ACTIVITIES u Introduced legislation in AZ - would make CL Rx expiration dates 5 years, not 1 - defeated in AZ u In Utah, introduced legislation to allow the CL prescription to be based on a “simple on-line questionnaire” - defeated for now, but very powerful (i.e. have given lots of money to) Utah legislators u In October 20, 2017 federal judge ruled 1-800 practices harmful to the public - illegal, anti-competitive practices on search engines Indiana University School of Optometry
1-800 ACTIVITIES u In AZ, have hired attorneys to file over 3,000 formal complaints against over 500 AZ ODs u Complaints filed with state Opt. Board - none have been filed by a patient, all by 1-800 att. - all claim violation of verification rules of FCLCA - Board must investigate every complaint - the complaint gives a “date, and claim of failure to verify” but no patient names; impossible to investigate - Is NO requirement to verify by OD in FCLCA Indiana University School of Optometry
FCLCA REVIEW u Fairness to Contact Lens Consumers Act u Set a 1 year CL Rx expiration date u Requires online or phone sellers to verify the CL Rx with the prescriber u Verified by - confirm it is correct - advise it is not correct or correct but expired - passive verification if no response within 8 business hrs Indiana University School of Optometry
FCLCA REVIEW u If passive verification, seller can fill it only that 1 time u Study found 58% of yearly CL Rxs filled by 1-800 received a notification toward the end of that year that their Rx was about to run out & did they want to order more u They then sold them another year of CL, meaning they extended the expiration date to 2 years Indiana University School of Optometry
FCLCA REVIEW u If a patient gives the seller the numbers on their box (the websites tell them where to look for them and what to give) u They can list a random doctor (not theirs) u Seller attempts to “verify” u Likely no response; “Never heard of them” u This then amounts to passive verification, and the seller can fill it Indiana University School of Optometry
INFLUENCE ON FTC u FCLCA under review; staffers took much information and rendered opinion almost totally based on 1-800 information or influence on the office reviewing the rule u Result is a proposed revised FCLCA rule that would be very harmful to ODs and seem to be of little value protecting the welfare of patients u 96% of patients who wear CL are satisfied with their CL purchase options Indiana University School of Optometry
FTC PROPOSED RULE – GIVE CL RX & GET “ACKNOWLEDGEMENT” u Must be entitled ‘‘Patient Receipt of Contact Lens Prescription,’’ u Must state ‘‘My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand that I am free to purchase contact lenses from the seller of my choice.’’ u Form must include the name of the patient, patient signature, and the date the form was signed. u Prescribers are required to maintain the signed acknowledgments for a period of not less than 3 years. Indiana University School of Optometry
PROPOSED FTC RULE u https://www.ftc.gov/system/files/documents/ federal_register_notices/2016/12/ contact_lens_rule_published_frn12716.pdf u Read (just google) the FTC CL prescription proposed rule (if you do not tend toward high blood pressure) u FTC announced a CL Workshop on March 7 on the proposed rule - Independent estimate of new rule will cost OD $20,000/yr - https://ftcpublic.commentworks.com/ftc/contactlensworkshop u stopillegalCLs@aoa.org they will report for you
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