An update on Dr. Friedman’s article last year on the state of ophthalmic technology outside the United States, as well as a look at this year’s new FDA approvals.
We are all well aware of the slow process that drugs and devices must undergo to gain approval in the United States. Recent changes to the regulatory pathway have somewhat improved the difficult road to FDA approval, but it is still frustrating to witness the incredible innovations of U.S. companies that are used OUS (outside the U.S.), while U.S. surgeons must settle for outdated and sometimes inferior technology.
Most Exciting Technologies OUS
Phakic Intraocular Lenses
The most modern Visian® ICL™ (STAAR® Surgical) implants include a toric model and the CentraFLOW, but are not available in the U.S. The CentraFLOW design consists of a central hole to allow fluid to pass through the lens avoiding the added step of creating an iridotomy. Although the astigmatism correcting ICL was recommended for approval two years ago, U.S. surgeons still do not have access to it.
Advanced Technology IOLs
A variety of unique IOLs are only available OUS:
- The Light Adjustable Lens (CalhounVision): is a silicone lens, the optics of which can be modified with a UV light source postoperatively to correct for residual refractive errors. Numerous trifocal and multifocal IOL designs are widely used outside the U.S., and many of these lenses are also available in toric models.
- FineVision trifocal (PhysIOL): is aspheric, diffractive, apodized surface IOL with +3.5 D near add and +1.75 D intermediate add.
- AT LISA tri® (Carl Zeiss Meditec): is a hydrophobic, acrylic, diffractive, plate haptic IOL with +1.66 D intermediate add and +3.33 D near add.
- M-flex® T multifocal toric (Rayner): is a multi-zone refractive, aspheric, one-piece acrylic IOL with a 3 or 4 D near add and astigmatism correction from 1.00 to 6.00 D in 0.5 D increments.
- Lentis Mplus, Mplus toric and Lentis Comfort (Oculentis®): is a refractive, one-piece, acrylic, plate haptic lens available in a 1.5 or 3.0 D near add.
Accommodating IOLs
These IOLs utilize various designs to change shape or flex in order to increase focusing power. Examples include FluidVision™ (PowerVision), Lumina (Akkolens), and DynaCurve (NuLens), all of which are still in trials.
Minimally Invasive Glaucoma Surgery
Although a number of devices have been FDA approved, there are several other promising technologies that have not. The Hydrus™ Microstent (Ivantis) is placed ab interno to act as an intracanalicular scaffold enlarging Schlemm’s canal. And the DeepLight Gold Micro-Shunt (SOLX) is placed ab externo into the supraciliary space to increase uveoscleral outflow.
New Technologies to Gain FDA Approval
Collagen Cross-Linking (CXL)
The FDA has finally approved the Photrexa®/KXL System (Avedro) for CXL in patients with progressive keratoconus. The procedure consists of exposing the cornea to riboflavin (Photrexa or Photrexa Viscous) and UV light (KXL System) in order to strengthen it.
Laser Vision Correction
VisuMax® femtosecond laser (Carl Zeiss Meditec) received FDA clearance for the ReLEx (Refractive Lenticule Extraction) SMILE (Small Incision Lenticule Extraction) procedure, a minimally invasive, flapless, treatment for myopia (in patients age 22 years or older with correction of -1 to -8 D and no more than -0.5 D of astigmatism).
Intracorneal Inlays
These small implants are placed in the nondominant eye to treat presbyopia. There are now two products that are FDA approved. The Kamra™ (AcuFocus) is a small aperture polyvinylidene implant that utilizes the pinhole effect to increase depth of field. It consists of a 3.8 mm opaque disc with a 1.6 mm central opening and thousands of micro-perforations to allow nutrient flow through the lens. And the Raindrop® Near Vision Inlay (ReVision Optics) is a neutral power hydrogel lens that steepens the central cornea to create a multifocal effect. A third lens design, the Flexivue Microlens™ (Presbia), is still under FDA investigation.
IOLs
The Tecnis Symfony® ZXR00 (AMO) and Tecnis Symfony Toric (ZXT) are the first extended depth of focus (EDF) IOLs available in the U.S. The toric version can correct up to 2.57D of cylinder at the corneal plane. This one-piece acrylic IOL is designed on the Tecnis platform, but it has an anterior aspheric surface and a posterior achromatic diffractive surface to preserve image quality and contrast sensitivity. Compared to multifocal diffractive IOLs, the Symfony EDF design results in 50 percent less loss of light, increased depth of focus, and reduced glare/halo.
Minimally Invasive Glaucoma Surgery
The CyPass® System (Alcon) recently gained FDA clearance. This polyamide stent inserted into the supraciliary space increases uveoscleral outflow in patients with primary open angle glaucoma. This month another device, the XEN® Glaucoma Treatment System (Allergan), received FDA approval for insertion in patients with previous failed glaucoma surgery or who are unresponsive to maximum tolerated medical therapy. The XEN45 Gel Stent is a gelatin implant placed into the subconjunctival space ab interno to create a new drainage channel. Other MIGS devices that are approved for use in the US include the EX-PRESS® minishunt (Alcon), Canaloplasty (iScience Interventional), Trabectome (NeoMedix), and iStent® (Glaukos).
Retinal Imaging
There are now two OCT Angiography (OCTA) systems that have received FDA clearance — the AngioPlex™ OCT Angiography (Carl Zeiss Meditec) and the AngioVue™ Imaging System (Optovue). These devices allow visualization of the retinal and choroidal vasculature without the need for fluorescein dye intravenous injection. This noninvasive method for visualizing abnormal blood vessels in the eye is one of the most
And the PanoCam™ Pro (Visunex Medical Systems) received FDA clearance for wide-field imaging for newborn infants. This device can image external, anterior segment, and posterior segment pathology that may result in childhood vision disorders.
Pediatric Vision Scanner
The Pediatric Vision Scanner (REBIScan) is an easy to use, handheld, reliable device to aid in the diagnosis of amblyopia and strabismus. It uses retinal birefringence scanning with polarized light to evaluate the pattern of foveal nerve fibers to detect fixation. Scanning time is 2.5 seconds and accuracy is 95 percent. It is particularly helpful for screening preverbal children.
Pharmaceuticals
The topical medication Xiidra™ (lifitegrast 5%; Shire) received FDA approval for treating the signs and symptoms of dry eye disease. BromSite™ (bromfenac 0.075%; Sun Ophthalmics) is a topical NSAID that gained FDA clearance for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. And Humira® (adalimumab; AbbVie) is a biologic agent now approved for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.