What Is Happening In the Gas-Permeable Contact Lens Industry

The Gas-Permeable Contact Lens

The mainstay of treatment for our patients with keratoconus are gas-permeable lenses.  Corneal gas-permeable (GP) lenses have been the treatment of choice for over 40 years and fit approximately two-thirds the size of the cornea.  Corneal GP lenses translate and pump tears and oxygen under the lens with each blink.  Hybrid lenses have a GP center bonded to a soft skirt that cushions and centers the lens.  Scleral lenses are very large diameter lenses that completely vault the cornea and land on the relatively insensitive scleral tissue.  Whether they are corneal GP, hybrid, or scleral lenses, the commonality is that all of these strategies use the optics and rigidity of GP materials to provide the best vision and comfort for this challenging condition.

gas-permeable contact lens
Well-fit corneal GP lens with sodium fluorescein dye

The way that the GP industry works is that GP button manufacturers (there are 6 in the US) sell the raw material, or button, to independent laboratories (there are 39 in the US) who then craft the button using industrial lathes into hundreds of lens designs using their own intellectual property.   GP buttons are used to make corneal GPs, hybrid, and scleral lenses.  Doctors who are skilled in fitting and evaluating the lens designs craft custom made GP lenses for their patients for whatever purpose benefits the patient.

Not many people know that the GP lens industry is on fire right now.  The turmoil began when Valeant Pharmaceuticals purchased Boston Products.  Boston Products manufactures the raw material of GP lenses, GP buttons, and held around 80% of the US market share.

The independent laboratories have a trade association called the Contact Lens Manufacturer’s Association (CLMA) who have an educational wing called the Gas-Permeable Lens Institute (GPLI).  The GPLI is universally beloved by practitioners because its primary function is to educate doctors to become better doctors in a non-branded, good-of-the-industry format.  No lens design is favored over any other.  Education is free to all doctors and expertise in specialty lenses is stressed, so that patients are placed in skilled hands.  Jan Svochak, president of the CLMA, says, “The CLMA represents a longstanding group of Independent Contact Lens Manufacturers working collaboratively where we have shared goals. These include educational resources through the GPLI that work closely with Eye Care Practitioners and Educational Institutions as well as a dedication to protecting and advancing utilization of custom manufactured contact lenses.”

Next Valeant dropped the hammer on the industry.  Overnight and for no apparent reason, they sent a letter to all of the independent laboratories announcing that they were increasing the price on scleral lens-sized Boston buttons by an astounding 60% (and other buttons by multiples).  Simultaneously, they announced that they were dropping out of the CLMA.  This move stunned the CLMA member labs as it blocked them from supplying Paragon CRT lenses to doctors.  Being the market leading GP button manufacturer, dropping out of the CLMA essentially defunded the GPLI and ensured the immanent collapse of the CLMA.

The price increase sent shock waves throughout the industry.  There was a simultaneous but independent reaction from many of the key-opinion leading optometrists who fit GP lenses.  The problem with any increase in price on the GP button level is that these price increases are passed down the line through the laboratories, the doctors and eventually, to the patients.  Valeant saw a huge backlash from optometrists who essentially stopped prescribing their materials.  They admitted making a mistake, and lowered the cost of the buttons, but interestingly, not to the original level.  Instead, there was an average 16% increase in the cost of scleral lens buttons to the laboratories.  Similarly, Valeant did not rejoin the CLMA.  The cost increase has been reported to fund Valeant brand specific education.

The other members of the CLMA came together and saved the association and the GPLI.  Additionally, a key competitor to Valeant, Contamac, rejoined the CLMA.  Contamac is a button manufacturer who formerly held around 8% market share of GP buttons.  At present, key sources within the industry believe that the market share has essentially flip-flopped, so that now, Contamac has rapidly gained market share of the GP button space as doctors have largely abandoned Boston materials in protest of these moves.

In a reactionary panic, Valeant has most recently written to the CLMA, asking to rejoin, but paradoxically with demands.  The CLMA is currently reviewing whether to allow Valeant to rejoin and under what terms.  Long term, it is beneficial for the industry for everyone to work together for the common good. It is unfortunate that a large company has come into the keratoconus treatment area and is raising prices without providing any real value, such as research and development into newer and better tools.  Companies like Valeant ultimately need to realize that they are not in control of an industry.  The patients and doctors are.

 

Dr. Sonsino is a partner in a high-end specialty contact lens and anterior segment practice in Nashville, Tennessee.  For over 12 years, he was on the faculty at Vanderbilt University Medical Center’s Eye Institute.  Dr. Sonsino is a Diplomate in the Cornea, Contact Lens, and Refractive Therapies Section of the American Academy of Optometry (AAO), chair-elect of the Cornea and Contact Lens Section of the American Optometric Association (AOA), a fellow of the Scleral Lens Education Society, board certified by the American Board of Optometry (ABO), and an advisory board member of the Gas Permeable Lens Institute (GPLI).  He lectures internationally, publishes in peer-review and non-peer-reviewed publications, and operates the website: TheKeratoconusCenter.org.  He consults for Alcon, Art Optical, Allergan, Johnson & Johnson, Optovue, Synergeyes, Visionary Optics, Visioneering, and formerly for Bausch & Lomb.

3/30/16

Sonsino Headshot

Jeffrey Sonsino, OD, FAAO
The Contact Lens Center at Optique Diplomate
Cornea, Contact Lens, and Refractive Therapies,

New Technology for Evaluating Contact Lenses

5/1/14

Successful management with contact lenses can sometimes be a frustrating process for those with keratoconus. The fitting and evaluation process involves numerous visits to the optometrist, out of pocket expenses as well as medical insurance co-pays. Luckily, the contact lens industry has responded to the need to have better contact lens materials for patients with keratoconus. It used to be that the only contact lenses available to manage keratoconus were gas-permeable (GP) lenses. Now, more and more patients are being fit with newer generation hybrid lenses (GP lens core with a skirt of soft lens material to aid in fit and comfort) and scleral lenses (large diameter GP lenses that do not rest on the cornea, only the outlying sclera). These newer designs are intended to vault over the central cornea and do not rest on the cornea at all. They have resulted in much more comfortable and wearable strategies for full-time use. As a result of the newer lens designs, the game has changed when it comes to the science of fitting and evaluating the lenses.

For years, optometrists have used corneal topography to guide their decision making on fitting keratoconic eyes. A corneal topographer is an instrument that maps the shape of the cornea, and gives information much like that of a topographical map for hiking. Corneal topography is still an absolutely mandatory part of evaluating the shape of the cone, the simulated corneal curvature, and monitoring for progression of the disease, and is not a standard part of a typical eye examination. However, doctors have a new tool at their disposal for fitting contact lenses on patients with keratoconus.

Optical Coherence Tomography (OCT) was once reserved for use in the back of the eye, or retina. OCT uses visible light passed through the clear structures of the eye to generate a cross-sectional image of the layers of the retina, much like an image generated by an MRI. Advances in OCT technology has improved the resolution to image the eye on the micrometer scale (one-thousandth of a millimeter). OCT technology is now commercially available not only for the retina, but the structures of the front part of the eye. The obvious application is to aid the doctor in the fitting and evaluating complex contact lenses that vault the cornea.

Figure 1. OCT image of a scleral lens fit on a keratoconic patient. The cornea is the opaque white band located at the bottom of this picture, the tear film reservoir is the middle clear band and the contact lens is the top band. Using an electronic caliper tool, the precise amount of vault can be measured, leaving no doubt as to the precision of the fit.
Figure 1. OCT image of a scleral lens fit on a keratoconic patient. The cornea is the opaque white band located at the bottom of this picture, the tear film reservoir is the middle clear band and the contact lens is the top band. Using an electronic caliper tool, the precise amount of vault can be measured, leaving no doubt as to the precision of the fit.

OCT allows the optometrist to view a cross-sectional image of the contact lens on the eye in real time and to monitor the health of the cornea in the presence of the contact lens. This view is valuable for judging the vault of new designs of contact lenses over the cornea and judging where the lenses land on the eye. It is the most specific way to determine if the fit is acceptable and to troubleshoot if lenses are not fitting appropriately.

Figure 2. OCT image of the periphery of a scleral lens on a patient with pellucid marginal degeneration. The lens contacts the cornea over an area of 0.87mm long. These types of measurements help guide decision making in modifying the lens fit and were impossible before the advent of this technology.
Figure 2. OCT image of the periphery of a scleral lens on a patient with pellucid marginal degeneration. The lens contacts the cornea over an area of 0.87mm long. These types of measurements help guide decision making in modifying the lens fit and were impossible before the advent of this technology.
Figure 3. Hybrid lens on a highly irregular eye after corneal transplant. The point of contact of the soft skirt with the cornea is visible to the right of the image.
Figure 3. Hybrid lens on a highly irregular eye after corneal transplant. The point of contact of the soft skirt with the cornea is visible to the right of the image.

Optometrists now have a much more powerful tool for evaluating and managing even the most challenging contact lens fits. It remains to be seen whether this technology has the ability to reduce the number of visits required for successful fit. But, the precision afforded by this technology does have the ability to improve patient outcomes.

Sonsino HeadshotJeffrey Sonsino, OD, FAAO
The Contact Lens Center at Optique Diplomate
Cornea, Contact Lens, and Refractive Therapies