In 2016, we witnessed many new developments in ophthalmology. The U.S. FDA approved a variety of products that had been eagerly awaited for years, and there were a number of novel technologies that were introduced. Below is a review of some of the products from the past year that I found to be most exciting.
Collagen cross-linking (CXL)
The Photrexa®/KXL® System (Avedro) obtained FDA approval after a lengthy multi-center US trial. The riboflavin and UV light therapy is now available to treat patients with progressive keratoconus. CXL has also demonstrated efficacy globally in the treatment of keratectasia after corneal laser vision correction procedures as well as for the treatment of infectious keratitis.
Dry Eye Disease
Novel treatments for dry eye have been a major area of research over the past decade. This past year, the topical agent Xiidra® (lifitegrast 5%; Shire) gained FDA approval to treat the signs and symptoms of dry eye disease. In addition, data from two pivotal studies of the Oculeve Intranasal Tear Neurostimulator device (Allergan) were submitted to the FDA and approval is expected shortly.
Laser Vision Correction
The newest technique in refractive surgery for myopia is the Small Incision Lenticule Extraction (SMILE) procedure, in which a femtosecond laser cuts a central stromal disc that is removed through a tiny corneal incision. The VisuMax® laser (Zeiss) is FDA cleared for SMILE in the U.S. to treat myopia ranging from -1D to -8D in individuals age 22 years and older.
Presbyopia Correction
Corneal and scleral implants to surgically treat presbyopia have been under investigation for decades, and now two of the products are commercially available in the U.S. — the Raindrop® Near Vision Inlay (ReVision Optics) and the KAMRA™ inlay (AcuFocus). The third corneal implant, Flexivue Microlens™ (Presbia), is awaiting FDA clearance.
There have been refinements in the scleral implant system VisAbility (ReFocus), which expands the sclera over the ciliary body and may become a viable alternative to the corneal implants.
In addition, a new class of intraocular lens implants, Extended Depth of Focus (EDOF) IOLs, have been FDA approved. The Tecnis® Symfony and Tecnis Symfony Toric (AMO) utilize chromatic aberration to provide a range of vision from distance to near without reducing contrast sensitivity or causing glare and halos. The toric version of the lens is available in three cylindrical powers to correct up to 2.57 D of corneal astigmatism.
Capsulotomy Devices
Femtosecond laser platforms produce exquisitely precise and reproducible capsulotomies for cataract surgery, however, the major concern of this technology is cost. As a result, cheaper alternatives are being developed. The Zepto (Mynosys) is a disposable device placed inside the eye under direct visualization that uses nanopulse technology to create a 5.2 mm round capsulotomy in 4 milliseconds. Another emerging technology is the CAPSULaser™ (Excellens) — a microscope mounted thermal laser that cuts a capsulotomy in a second, but requires that the capsule be stained with trypan blue.
Minimally-Invasive Glaucoma Surgery
The iStent® (Glaukos) was the first micro stent to be FDA approved for implantation in glaucoma patients at the time of cataract surgery. There are now two new ab interno devices that are available in the U.S. The CyPass® Micro-Stent (Alcon) is placed in the supraciliary space to enhance uveoscleral outflow, and the XEN® Glaucoma Treatment System (Allergan) is positioned in the subconjunctival space to produce a new drainage channel.
The next generation iStent, the iStent inject Trabecular Micro-Bypass Stent, consists of two stents in a preloaded auto-injection device and is being evaluated for use in conjunction with cataract surgery as well as for a stand-alone procedure in patients with glaucoma.
Retinal Imaging
OCT angiography (OCTA) is the most exciting new development in retina diagnostics. Two systems have been approved by the FDA — the AngioPlex™ OCTA (Zeiss) and the AngioVue™ Imaging System (Optovue). This revolutionary technology enables doctors to non-invasively visualize the retinal and choroidal vasculature (i.e., injection of IV fluorescein dye is no longer necessary).
Another game changer in retinal imaging is the PanoCam™ Pro (Visunex Medical Systems). This wide-field camera captures high quality external, anterior segment and posterior segment photos in newborn infants. It is primarily used in hospitals to efficiently screen newborns who are at risk for ROP.
Uveitis
In 2016, a new treatment for uveitis was approved. Humira® (adalimumab; AbbVie) is the first biologic agent to receive FDA approval for the treatment of non-infectious intermediate, posterior, and panuveitis in adults. It is administered as a subcutaneous injection.
With so many interesting ophthalmic technologies currently under investigation and the seemingly more streamlined FDA approval process, I look forward to reporting on many more exciting products brought to market in 2017.
Like what you read? Follow OphthalmologyWeb to keep up with our latest articles, news and events. Plus, get special offers and more delivered to your inbox.