The FDA approval process for drugs and medical devices is notoriously slow in the United States. I have written articles highlighting the many ophthalmic technologies developed in the U.S. but only available outside the country. I am now pleased to write about new products in eye care that have recently been approved by the FDA.
Here are some of the most exciting ophthalmic FDA approvals in the past year:
KAMRA inlay from AcuFocus: This intracorneal inlay is the first such device approved in the U.S. for the surgical correction of presbyopia. It is a small aperture implant that utilizes the pinhole principle to increase depth of focus and thereby improve near vision. The KAMRA inlay is inserted into a femtosecond laser created central corneal pocket of the patient’s nondominant eye. The dimensions of this polyvinylidene device are as follows: 3.8 mm opaque disc, 1.6 mm central opening, 5 micron thickness, 8400 microperforations to allow nutrient flow.
Competing technologies, which have not yet gained FDA approval are the Raindrop Near Vision Inlay from ReVision Optics and the Flexivue Microlens from Presbia. The former is a neutral power, hyperprolate, hydrogel inlay (2 mm diameter, 32 micron thickness) that steepens the central cornea to produce a multifocal effect, and the latter is a hydrophilic, acrylic device (3 mm diameter, central plano zone surrounded by a ring of peripheral power ranging from +1.25 to +3.5 D, 15 micron thickness, and a 0.15 mm central opening for nutrient transfer) that increases corneal refractive power producing slight myopia and thus monovision.
Expanded range multifocal IOLs: Alcon and AMO have both expanded the range of near adds for their multifocal IOL platform. The Acrysof IQ ReSTOR MF IOL from Alcon now comes with a +2.5 D add design. The TECNIS MF IOL from AMO is now available in two additional models designated ZKB00 (+2.75 D add) and ZLB00 (+3.25 D add). These lenses have a significantly lower incidence of glare and halo from light sources.
Preloaded IOL systems: Foldable IOLs require manipulation to fold and/or insert into injector cartridges. Preloaded systems offer the advantages of fewer manipulations and better sterility. The TECNIS preloaded IOL (PCB00) from AMO is a disposable screw-style injector device available with a complete power range of monofocal IOLs (+5.0-+34.0 D). The preloaded IOL can be inserted through a 2.2-2.4 mm corneal incision.
iDesign Advanced Wavescan Studio System from AMO: This redesigned device is a combined aberrometer, topographer, and pupilometer that precisely measures data and converts the information to a treatment plan for the VISX Star S4 IR Excimer Laser System. This integral part of the laser vision correction procedure ensures the most accurate wavefront-guided treatment.
ReSure Sealant from Ocular Therapeutix: This surgical sealant is utilized at the conclusion of cataract surgery to ensure watertight closure for leaking corneal incisions. It is easy to prepare and apply, it works rapidly, and it is comfortable for the patient.
Phakic Intraocular Lenses: The popular Visian ICL from Staar Surgical is available in a toric design to correct astigmatism. Although the FDA panel recommended approval of this phakic IOL last year, the lens has not yet received final clearance. Hopefully, the toric ICL will be available later this year, and it would also be nice to see approval of the V4c CentraFLOW model in the near future.
Omidria from Omeros: This preservative-free injectable medication combines phenylephrine 1% and ketorolac 3% and is added to ophthalmic irrigation solution used during cataract surgery to reduce intraoperative miosis and postoperative pain. Omidria has been granted pass-through payment status under Medicare and has its own unique billing code (C9447) for reimbursement separate from the bundled payment for the surgery.
Eylea: The FDA approved expanded indications for aflibercept. This drug initially gained clearance for wet macular degeneration. It is now also approved for the treatment of diabetic macular edema and macular edema after branch retinal vein occlusions.
Iluvien from Alimera Sciences: This is a fluocinolone acetonide intravitreal implant for the treatment of diabetic macular edema in patients who do not have a significant IOP rise with corticosteroids. After injection, the implant delivers continuous, low-dose steroid for 36 months.
The recently approved products discussed above represent a small fraction of the exciting technologies that have been developed in the U.S. but most of which are only available elsewhere around the globe because of delays in the regulatory process. I am happy there are finally enough of these new products to review in an article, and it would be nice if this trend continues.
I look forward to expanding the list of recently approved ophthalmic innovations in another report next year.