This article is more than 5 years old. Information may no longer be current.
The missing link: What technologies are lacking for US premium surgeons
The regulatory approval process has improved in recent years, but the US still lags behind many other parts of the world.
Click Here to Manage Email Alerts
As premium surgeons navigate through the various jungles of diagnostic devices, electronic health record options, pharmaceutical decisions, and surgical techniques, devices and IOLs, there still appears to be a large gap between the U.S. armamentarium and that of the rest of the world, including Europe, Canada, Asia, South America and India.
Recently, a patient reached out to me via email from India requesting my “expertise” on which IOL he should have implanted in his eyes. That patient was confused by the myriad of choices of “brand lenses” (our advanced premium IOLs) vs. “generic lenses” (our basic standard IOLs). Out of the 12 options, I could only offer guidance to this patient in two categories and no longer felt like an “expert,” for which I was called on in the first place. The challenges we face in the U.S. are in large part due to the regulatory approval process of surgical and pharmaceutical products. The enormous financial burden for certain companies to enter the U.S. market prevents this larger array of IOL options available in other countries.
Process should focus on safety
The U.S. regulatory process should revise its approach so that it is similar to the approval process of the CE mark and the Federal Aviation Administration in our own country. Although the regulatory process has improved immensely in the last year, the U.S. still remains a far cry behind the rest of the world, especially when it comes to IOL technology. The CE mark and FAA focus on safety and less on efficacy. If a product is not efficacious, it would not survive the market anyway, so industry obviously has motivation inherent on assuring efficacy. Safety is of prime importance when it comes to patient care, and it should be the primary regulatory focus in the U.S., as in other countries. A simple revision to the approval process would be if a product line is already approved in the U.S., such as the Visian ICL (STAAR Surgical), then the toric version and its newer CentraFlow technology should be available based on the vast amount of global data on safety on these latter technologies. The importance comes regarding safety to patients. By having these two latter platforms on an already-approved spherical ICL platform, it prevents the need for a second procedure to correct for astigmatism and/or a preoperative procedure to create iridotomies. Fewer procedures to arrive at the same outcome is safer for a patient, with the additional “wow” factor we want from our patients in the first place.
Other similar examples would be expediting the approval process for the Tecnis multifocal toric (Abbott Medical Optics), ReSTOR multifocal toric (Alcon) and enVista toric (Bausch + Lomb), as their primary platforms are already approved by the U.S. Food and Drug Administration. If a brand-new technology is not available elsewhere in the world yet, such as the Elenza Sapphire AutoFocal IOL (Elenza), it makes sense that a full regulatory approval process has to be followed. Many U.S. surgeons are still trying to have alternative technologies, such as the Sulcoflex piggyback IOL (Rayner Intraocular Lenses), to correct residual sphere and/or astigmatism after a patient already has an IOL in the capsular bag. This technology exists throughout Europe with CE approval and provides a safe approach to improved patient outcomes.
Access to technology, pharmaceuticals
The Affordable Care Act looks to bring expanded care to patients and make it affordable. Another missing link in ophthalmology is the limit of access of existing technologies and pharmaceuticals to our patients. The Centers for Medicare and Medicaid Services guidance from November 2012 on prior CMS rulings 05-01 in 2005 (presbyopia-correcting IOLs) and 1536-R in 2007 (astigmatism-correcting IOLs), with regard to imaging and femtosecond laser technology, has been the start of a process, allowing access for all patients to these advanced technologies. I give kudos to the Mercy system, led by surgeon Shachar Tauber, MD, for providing femtosecond laser technology to all patients on a not-for-profit platform. In reality, most premium surgeons are not in a situation to follow the Mercy method. I believe our system still needs further CMS guidance to allow all of our patients to have access to femtosecond laser technology, even with conventional IOLs, at a level that at a minimum covers the surgeon’s overhead for such advanced technology.
Ophthalmic pharmaceuticals
As for the pharmaceutical missing link, our health system is driving patients further to generic eye medications due to lower cost, but at what cost to patient safety and efficacy? Ophthalmic pharmaceuticals have always been a brand-driven approach with formulations suited for better ocular surface tolerability and enhanced formulations for efficacy. Reliance on patient compliance has been enhanced due to these better gel and emulsion type formulations, so only once or twice daily applications are needed compared with the four to six times daily applications needed with generics to achieve similar efficacy, and we know as surgeons that patients never remember to use drops four to six times daily. On the horizon, our options as part of the missing link are intraocular delivery of eye medications, such as transzonular delivery of TriMox + Vancomycin (triamcinolone, moxifloxacin, vancomycin, Imprimis Pharmaceuticals), punctal plug delivery of medications, enhanced intracameral formulations and/or nanotechnology. The recent tragedies stemming from the New England Compounding Center should only drive us in the ophthalmic world to deliver safer and more effective ocular pharmaceuticals to our patients.
In the end, despite our great armamentarium of diagnostic, surgical and pharmaceutical products in the U.S., the regulatory process, politics and access are limiting factors to fulfilling the missing link in this country. The good news is we are making progress, but not at a level that meets the expectations of our premium patients.
Stay tuned to my next column, Reaching a half century: What does this mean for the middle-aged premium ophthalmologist?