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
CONTACT LENS
INDUSTRY UPDATE
WHAT’S NEW IN CORNEA &
   CONTACT LENSES

 Neil A. Pence, OD, FAAO
      Associate Dean
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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 INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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
CONTACT LENS INDUSTRY UPDATE - WHAT'S NEW IN CORNEA & CONTACT LENSES Neil A. Pence, OD, FAAO
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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