If you fly at all, you can’t help but be a bit unsettled in the wake of two commercial airline tragedies over the past 6 months. What’s even more concerning is that both involved the same aircraft, the Boeing 737 Max 8.
Boeing – arguably the world’s preeminent aircraft manufacturer – has produced various reiterations of the 737 for more than 50 years, with the model serving as a workhorse in many commercial airline fleets around the world. Its record for safety, durability and efficiency is exceptional. So, what’s changed? While aviation experts search for a definitive answer, Boeing, commercial carriers and governmental agencies have – appropriately so – grounded the aircraft. In a situation this critical, or in any matter where safety is in question, it’s always prudent to err on the side of caution. It’s how the system is designed to work.
We have a similar safety system in health care in the form of the FDA. Phase 1, 2 and 3 studies largely determine the feasibility, safety and efficacy of any new drug or device. Post-FDA approval surveillance studies assure no long-term, unforeseen consequences. To a great degree, the system truly works.
In August 2018, Alcon Laboratories voluntarily withdrew its CyPass Micro-Stent device from the marketplace. While the device proved to be safe and effective in FDA clinical trials, receiving agency approval in 2016, Alcon elected to pull the device for precautionary reasons. Citing data from its postapproval surveillance study (COMPASS-XT), Alcon noticed a predilection for increased endothelial cell loss (ECL) in CyPass patients in comparison with controls. Some glaucoma specialists feel ECL is likely a function of device location (“CyPass migration uncommon, says glaucoma surgeon”), and many practices (ours included) continue monitoring successful CyPass patients. However, in an abundance of caution, Alcon did the prudent thing in recalling CyPass. It’s how the system is designed to work.
In the event of a drug or device recall, our first instinct is to question whether we’re pushing technology too fast and too far. It’s easy to reflect on more familiar and time-honored treatment modalities and ask why. In the case of glaucoma, where topical eyedrop options have improved so dramatically over the past 40 years, this is especially the case. Thankfully, long gone are the days of pilocarpine 2% four times a day. However, regardless of how patient-friendly a once-daily prostaglandin drop might seem, it’s often anything but perfect. Cost, compliance, side effects and continual disease progression in the face of apparently well-controlled IOPs all serve as a humbling reminder that we need to do more. In short, we all know our patients would benefit from additional glaucoma therapies.
In recent years, advances in glaucoma have largely come in the minimally invasive glaucoma surgeries space (CyPass included). And now we’re on the cusp of welcoming new treatments running the gamut from a variety of time-release medication platforms to ultrasound ablation-enhanced outflow. This month’s feature article, “Experts say future of glaucoma treatment may lie in sustained release,” provides valuable insight into the role these emerging technologies will likely play. While largely optimistic, our experts remind us there will inevitably be trials and tribulations along the way, and that glaucoma treatment will never be a “one-size-fits-all” proposition. However, the consensus is clear: We need better ways of treating glaucoma, and they will come via newer technologies. After all, it is how the system is designed to work.