After attending the BCLA Myopia Management Day, I got to thinking about how industry will respond to the conference highlights. There was much discussion about new optical designs which may emerge in the coming years. New optical designs will require research funding to measure their effects to ultimately achieve FDA approval for myopia control. Industry will need to provide considerable education to practitioners who may find a new lens design with a complex optical profile, which may not be analogous to the individual patient’s single vision equivalent correction. Myopia control is something, however, that our profession needs to tackle head-on. Here are my thoughts on soft lenses and myopia control from an industry perspective.
I was involved in the development of the Ciba Focus Night & Day (N&D) in the late 1990’s - the ground breaking first silicon hydrogel disposable soft contact lens. As well as being cutting edge research, the project was also a business case study. There were three research centres; one in Atlanta, one in Switzerland and the third at the CCLRU at the University of NSW (Australia), and they were using a central database to which all results were entered - so effectively you had 24-hour-a-day research with a central database of information, long before such international access was commonplace. They also realised that for such a breakthrough, development of a single channel, while cheaper, was less likely to produce a timely result, so they had over 20 different material and surface combinations in parallel development in the early stages. These were then narrowed down to the three most promising ones when we had enough information to make such a judgement.
I was working in a communications function in Atlanta when they carried out a study to narrow these three down to a prime candidate and a backup - a very exciting time. I was then transferred to Europe, where we carried out some of the clinical field work and did a lot of the market preparation with educational lectures to practitioners about extended wear and oxygen. I then went up to Scandinavia to work in marketing and launch Focus N&D.
One of the characteristics was that, although all lenses had significant spherical aberration, Focus N&D was produced in a very much ‘flatter’ power configuration. In the graph shown to the right you can see that with increasing power of a minus powered contact lens, increasing amounts of additional peripheral minus are induced 5mm from the centre of the optic zone. This effect was more pronounced for the Acuvue 2 than the Focus N&D. It follows that the higher the level of induced peripheral ‘minus’ in a soft contact lens, the more likely an individual patient would suffer higher amounts of relative peripheral hyperopia. The reverse was true for plus powers. This data was presented publicly back in 2006.
There is a significant volume of animal and human research which points to the feasibility of reducing relatively peripheral hyperopia in myopes to reduce myopia progression. This raises the question of whether designs which induce relative peripheral myopia could contribute to progressive myopia. As such, any practitioner who has been fitting N&D and a range of other lenses with higher minus in the peripheries over the past decade or so has a database that could be used to cross-check myopia progression in parallel populations. With a rigorous protocol and particular investigation of paediatric and young adult populations - the more likely myopia progressors - this sort of retrospective study could short-circuit doing prospective studies over a long period to find out if altering relative peripheral power is helpful in slowing myopia development. This could see new products coming to market more quickly, and even swifter achievement of FDA approval for claims of myopia control.
From an industry point of view, a prospective study with a new product is an enormous undertaking. With the N&D, we mostly had participants who were switching from hydrogels and it was not a straight swap, as the power needed to be adjusted above spheres of +/- 2.50 to compensate for differences in optical power profiles and even physiological changes in the cornea. Practitioners were frustrated by this, and in the case of a new myopia control soft contact lens which may do the same, the momentum of a new product from an industry perspective can be affected.
The concept of changing the relative peripheral optics of a contact lens for myopia control is covered in several patents, as is changing the on-axis optics of the eye through manipulating spherical aberration. The two can also be linked. We are likely to see developments in both of these arenas in the coming years as research and industry work to provide a solution to the global problem of progressing myopia.
There are a few key issue that industry faces in developing, testing and then educating practitioners on a new soft lens myopia control product.
- Re-tooling. Manufacturers cannot simply re-tool the same products to have less or more spherical aberration as this changes the equivalent power, and practitioners will not be able to make a direct switch from a patient’s single vision equivalent. Significant investment in new manufacturing processes, and research to support these, will be required.
- Verification. Any new optical solution for myopia control would involve pilot production and testing, and then quite some time afterwards to complete field studies to verify the effect. This could be assisted by the concept of a retrospective N&D vs other SCL study as I’ve described above. As was the case for N&D, it is likely that several versions of a lens design would need to be simultaneously produced and tested to determine the which optical profile is most effective.
- Marketing. Launching a new product can be more difficult in established markets where there is an often observed lag in switching to a new product - numerous successful wearers of an existing lens type can lend an ‘if it ain’t broke, don’t fix it’ practitioner mentality. For example, Eastern Europe is way ahead of the rest of Europe in the use of SiHy because they didn’t have the ‘baggage’ of a large body of existing hydrogel wearers. New markets simply go straight to the newest products, leapfrogging over all the intermediate ones. Significant investment in education is required.
- Mature company profitability. Large companies are answerable to their shareholders for profits, and the requirement is pretty well always higher, so they don’t always have the liberty to allocate a large amount of money over a long period of time to such developments. If they do, they need an enlightened head of R&D to define the path, and an enlightened management to trust the R&D folks to take them along it and defend the resources. An upstart disruptive technology company might do it, but you see these rarely in contact lenses - the best example nowadays is probably Sauflon, but they actually took 25 years to get to the first full family of SiHy DD lenses. For fast progress, we need big companies with deep pockets and dedicated teams, who are provided the resources and autonomy to do ground breaking work which may take many years to see fruition.
While this may seem to be a stormcloud view of the myopia control horizon, there is a silver lining. Increased research awareness of the worldwide problem of progressing myopia will see parallel investigations of both existing and new products. Increased practitioner awareness, evidenced in the BCLA dedicating a whole day of their 2015 conference program to myopia, will also contribute to global understanding through clinical experience. As mentioned above, we have a wealth of retrospective data available for study to inform the future. The development of silicon hydrogel disposable lenses was a defining moment for the contact lens industry, and myopia control is the opportunity for another.