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The BJO is primarily a clinical and scientific journal and rarely comments on commercial activities. Nevertheless, the recent developments in the field of glaucoma surgery,1 merit some comment. An area that has traditionally failed to attract significant commercial interest has in the last few years been a hive of commercial activity, especially in the last 4 months. During this time the United States Food and Drug Administration (US-FDA) approved the iStent Inject (June 2018), followed 2 months later by approval of the Hydrus Microstent. MIGS has appeared to be on an upward trajectory, leaving many traditional glaucoma specialists contemplating how their practices should evolve.
While much of this activity has been commercially-focused, there have been notable concomitant achievements in the quantity and quality of the evidence base for a number of the new devices that have received approval, which is good for patients, the industry and ophthalmology in general. The efficacy and safety of recently approved devices such as the iStent, CyPass Micro-Stent and Hydrus Microstent, unlike many previous devices, have all been evaluated in randomised clinical trials, albeit only in trials where the device in combination with cataract surgery has been compared with cataract surgery alone. This has set a new benchmark for the approval of surgical implants in glaucoma.
The recent news that Alcon has voluntarily withdrawn the CyPass Micro-Stent from the global market in August 2018 has therefore come as a shock to many, prompting the inevitable doomsday predictions of the demise of MIGS from naysayers, who feel vindicated for refusing to join the MIGS bandwagon. However, before reaching hasty conclusions, it is important for us …
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