2016: The Year in Approvals

As 2016 comes to a close, AOC takes a look back at the key eye care moves made by the FDA.

By Conni Bergmann Koury, Editor-in-Chief

FDA Approves the Tecnis Symfony IOL, the First Extended-Depth-of-Focus Lens

The Tecnis Symfony IOL (Abbott) is the only lens in the United States that provides a full range of continuous vision following cataract surgery while also mitigating the effects of presbyopia, according to the manufacturer. The FDA approval includes a version of the lens for people with astigmatism, the Tecnis Symfony Toric IOL.

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“The lens is different from a traditional multifocal IOL in that it doesn’t split light between near and distance focal points,” Jason Jones, MD, of the Jones Eye Clinic in Sioux City, Iowa, and a clinical investigator for the Tecnis Symfony IOL, said in a conversation with AOC’s news site Eyewiretoday.com. “Rather, a diffractive echelette design feature extends the range of vision, while achromatic technology reduces chromatic aberration to increase contrast sensitivity and enhance quality of vision.”

The approval was based on results of a US pivotal study that compared the Tecnis Symfony lens to a Tecnis aspheric monofocal lens in 298 patients. In the prospective, randomized, subject- and evaluator-masked study, 148 subjects were bilaterally implanted with the Symfony lens and 150 with the ZCB00 Tecnis monofocal lens. Mean age and gender was similar in both groups.

Monocular and binocular distance visual acuities for the Symfony subjects were clinically comparable to those of the monofocal control lens group. Monocular intermediate visual acuity with the Symfony lens was 1.7 lines (uncorrected) to 2.4 lines (distance-corrected) better than in the control group. Mean binocular uncorrected visual acuity at intermediate (66 cm) was 20/20 (0.002 LogMAR) at 6 months, and mean binocular uncorrected visual acuity at near (40 cm) was between 20/25 and 20/32 (0.146 LogMAR), according to data presented by Dr. Jones.

Patients in the Symfony group were also more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition. Rates of adverse events did not differ between the Symfony and monofocal groups.

“One of the things I’m excited about as a participant in the US clinical trials was the fact that we saw such a low incidence of glare and halos,” James Loden, MD, president of Loden Vision Centers, Nashville, said in an interview with Eyewiretoday.com. “In fact, in the US clinical trials, halos were reported as being severe in less than 2.8% of patients—really different than the 20% rate of halos that we see in some of the traditional diffractive optic lenses that we’ve used in the past.”

Bausch + Lomb Receives FDA Approval of Trulign Toric IOL Calculator Enhancements

Bausch + Lomb received approval from the FDA for a number of enhancements to its Trulign Toric IOL calculator.

Designed to help further streamline the Trulign Toric IOL fitting process, the FDA approval of the company’s recent enhancements to the Trulign Toric calculator will provide surgeons and technicians a simplified design that is easy-to-use, convenient, and accessible, according to a news release. The calculator enhancements, which were updated based on direct feedback from customers, will include a number of refinements allowing users to interface directly with the IOLMaster (Carl Zeiss Meditec) or Lenstar (Haag-Streit) systems to help facilitate the input of patient data and create a seamless user experience and display the make and model of the Crystalens IOL, if a nontoric lens is recommended, while displaying the IOL at 90º with no axis of alignment.

Abbott Releases Tecnis Toric Calculator With Posterior Corneal Astigmatism Compensation

Abbott received FDA approval of a new toric calculator with posterior corneal astigmatism (PCA) compensation. The addition of PCA compensation eliminates the need for look-up tables and improves the predictability of residual astigmatism, according to an Abbott statement.

Clinical studies found that PCA adds an average of 0.30 D to total corneal astigmatism. Not accounting for PCA in calculating the required toric lens needed to correct an individual’s astigmatism may result in over-correction of with-the-rule astigmatism, undercorrection of against-the-rule astigmatism and decreased patient satisfaction, according to Abbott.

“By incorporating posterior corneal power and an exact vergence calculation for both toric and spherical IOL power, the new Tecnis Toric IOL calculator elegantly and comprehensively addresses posterior corneal astigmatism and potential inaccuracies,” Douglas D. Koch, MD, Houston, who helped develop the Abbott PCA algorithm for use in the Abbott Toric Calculator.

The Abbott Toric Calculator with PCA compensation is optimized for use with the Tecnis family of toric IOLs, including the recently released Tecnis Symfony Toric Extended Range of Vision IOL. There was a 0.01 D prediction error shown when utilizing the Abbott PCA algorithm, according to the company.

FDA Approves Shire’s Xiidra (Lifitegrast) for the Signs and Symptoms of Dry Eye Disease

The FDA has approved Shire’s blockbuster dry eye treatment Xiidra (lifitegrast ophthalmic solution 5%), marking the first prescription pharmacologic treatment option for dry eye disease (DED) approved in more than a decade and providing millions of Americans another option in the growing DED segment.

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Xiidra is a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of DED in adult patients. Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition. Shire subsequently launched Xiidra in the United States in the third quarter of 2016.

“The FDA approved Xiidra (lifitegrast ophthalmic solution 5%), marking Shire’s first approval in ophthalmics,” Bob Dempsey, vice president and head, ophthalmics, Shire, said in a statement to Eyewiretoday.com. “This also is a major milestone for the eye care professionals treating this often chronic condition who have not had a new, FDA-approved treatment option in more than a decade.”

Allergan Introduces Preservative-Free Restasis Multidose

Allergan received approval from the FDA for Restasis Multidose (cyclosporine ophthalmic emulsion) 0.05%, a preservative-free, multidose bottle offering the same preservative-free formulation of Restasis since the launch in 2003. Restasis is the one and only prescription treatment FDA approved to help patients with a type of chronic DED make more of their own tears, according to a news release.

Restasis helps increase the eyes’ natural ability to produce tears, which may be reduced by inflammation due to chronic DED. Restasis did not increase tear production in patients using antiinflammatory eye drops or tear duct plugs.

“Restasis Multidose will be an important addition to the Allergan family of dry eye products, as it will enable health care providers to offer an additional option for those patients who may prefer their eye drops in a multidose bottle versus single-use vials,” Neda Shamie, MD, fellowship-trained cornea and cataract specialist, of Advanced Vision Care, of Los Angeles, said in a company news release.

Restasis Multidose is designed with a patented unidirectional valve and air filter technology that eliminates the need for a preservative. The new multidose bottle uses less plastic than a package of single-use vials and will be available for the same price.  

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Humira Receives FDA Approval to Treat Adults with Noninfectious Intermediate, Posterior, and Panuveitis

The FDA approved Humira (adalimumab) for the treatment of noninfectious intermediate, posterior, and panuveitis. Humira is reportedly the first and only FDA-approved noncorticosteroid therapy available for adults for this indication. The approval marks the 10th approved indication for Humira in the United States for immune-mediated diseases, according to a company news release.

“We are pleased to provide patients with the first FDA-approved non-corticosteroid treatment option for certain types of uveitis, an eye disease that can flare and impact vision,” Mike Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie, said in the news release. “These approvals reflect our ongoing focus on continuing to innovate with Humira to address critical unmet needs of patients living with serious immune-mediated diseases.”

“These approvals provide a valuable option for patients experiencing flare and vision impairment associated with this group of inflammatory diseases of the eye,” Glenn J. Jaffe, MD, Duke University, Durham, North Caronlina, said in the news release. “Data from the robust VISUAL clinical trial program demonstrate the value of Humira as a treatment option for patients with these serious diseases.”

Sun Pharma Receives FDA Approval For BromSite

Sun Pharma announced that it has received approval from the FDA for BromSite (bromfenac ophthalmic solution) 0.075% for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

BromSite is the first nonsteroidal antiinflammatory drug approved by the FDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery, according to Sun Pharma. Other nonsteroidal antiinflammatory drugs in this class are currently indicated for the treatment of inflammation and reduction of pain.

BromSite is the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. Sun Pharma acquired InSite Vision in November 2015 and is likely to commercialize BromSite through its newly formed, US-based division, Sun Ophthalmics, in the second half of 2016.

Allergan Receives FDA Clearance for the XEN Gel Stent, a New Surgical Treatment for Refractory Glaucoma

Allergan announced that the FDA has cleared the Xen Glaucoma Treatment System, which consists of the Xen45 Gel Stent and the Xen Injector. The Xen Glaucoma Treatment System reduces IOP in patients and is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or in patients with primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. Xen is implanted through an ab interno approach and reduces IOP by creating a new drainage channel with a permanent implant that becomes flexible. This provides a new treatment option for the millions of Americans with refractory glaucoma.

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“Allergan has a deep, long-term commitment to developing treatments for patients with glaucoma, a sight-threatening disease that affects millions in the United States and worldwide. We are thrilled to receive FDA clearance for the Xen Glaucoma Treatment System, which will provide a new treatment option for patients struggling to bring down their [IOP],” David Nicholson, chief R&D Officer at Allergan, said in a company news release.

FDA Approves CyPass Micro-Stent Minimally Invasive Glaucoma Surgical Device

The FDA has approved Alcon’s CyPass Micro-Stent system, the second minimally invasive glaucoma surgical device (MIGS) approved for use in combination with cataract surgery. The device helps to reduce IOP in adult patients with mild-to-moderate primary open-angle glaucoma.

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The CyPass System consists of the CyPass Micro-Stent, contained within a loading device, and a stent delivery tool. The device is designed for placement in the angle of the eye, with the proximal end extending into the anterior chamber, and the distal end residing in the supraciliary space. This allows outflow of fluid from the anterior chamber through the distal end into the supraciliary and suprachoroidal spaces.  

In February, Alcon entered into an agreement to acquire Transcend Medical, giving it the rights to the CyPass Micro-Stent system. Terms of the deal were not disclosed.

The Glaukos iStent Trabecular Micro-Bypass, which was approved by the FDA in June 2012, was the first minimally invasive glaucoma surgical device approved in the United States. It is currently approved in more than 20 countries.

Zeiss Receives FDA Clearance for Swept-Source OCT Posterior Ocular Imaging with PLEX Elite 9000

Carl Zeiss Meditec has received FDA clearance for the Zeiss Plex Elite 9000, the first swept-source optical coherence tomography (OCT) imaging technology for posterior ocular structures, according to a company news release. The swept-source OCT and OCT angiography (OCTA) platform was designed for advanced retina research and is at the core of the Advanced Retina Imaging (ARI) Network.

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The ARI Network, led by Philip J. Rosenfeld, MD, PhD, is a unique global consortium of clinicians and scientists from around the world working at the forefront of retinal disease research. The ARI Network is focused on exploring new clinical applications for the diagnosis and treatment of eye disease and advancing OCT innovation to benefit patients today and in the future. The FDA clearance will help US members of the ARI Network to more easily enroll patients and may facilitate faster Institutional Review Board review for protocol approval of research.

The wide-field high-resolution visualization provided by the swept-source OCT and OCTA imaging of the Plex Elite platform expands clinicians’ ability to examine the critical microstructures and microvasculature of the posterior segment at any depth of interest from vitreous to sclera.

“Zeiss’ swept-source OCT and OCTA platform is truly a remarkable breakthrough in our quest to achieve better, wider, deeper, and faster imaging of the retina and choroid. This instrument opens up a new world of structural and microvascular clarity. By imaging deeper and in greater detail than ever before, we will further our understanding of the retina and choroid, and greatly facilitate clinical trial investigations into different diseases,” Dr. Rosenfeld, chairman of the ARI Network, said in the news release. “This collaboration between the retina experts in the ARI Network and the engineers and scientists at Zeiss is vital to the advancement of retinal and choroidal imaging and scientific discovery.”


Topcon’s 3D OCT-1 Maestro Receives FDA Clearance

Topcon Medical Systems has announced that the 3D OCT-1 Maestro is now available for sale in the United States. The 3D OCT-1 Maestro System combines a high-resolution color nonmydriatic retinal camera with the latest spectral-domain OCT technology. The rotating touch panel and fully automated (alignment, focus and capture) operation make the 3D OCT-1 Maestro a diagnostic solution for even the smallest clinical practice, according to a company news release.

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Nidek Receives FDA 510(k) Clearance for the MP-3 Microperimeter

The FDA has issued 510(k) clearance for Nidek’s MP-3 Microperimeter, which measures local retinal sensitivity for functional assessment of the retina. The results can be displayed over a color fundus image, correlating retinal anatomy to retinal function.

For enhanced clinical assessment, the MP-3 now includes a wider range of stimulus intensity, from 0 to 34 dB, compared to the MP-1. The MP-3 measures perimetric threshold values, even for normal eyes. A maximum stimulus luminance of 10,000 asb allows evaluation of low-sensitivity. The Nidek auto tracking and auto alignment functions may provide more accurate measurements, increasing patient and operator comfort and efficiency. These functions allow easy follow-up and reduce variations between examiners, resulting in well-aligned follow up exams.

Retinal morphology can be evaluated with the 12-megapixel fundus camera included in the MP-3 unit which acquires high resolution images of retinal pathology and allows easy image acquisition.

Heidelberg Engineering Receives FDA Clearance to Market Spectralis OCT Glaucoma Module Premium Edition

Heidelberg Engineering announced that it has received FDA 510(k) clearance to market the Spectralis OCT Glaucoma Module Premium Edition, which provides a comprehensive analysis of the optic nerve head, retinal nerve fiber layer, and ganglion cell layer by precisely matching unique scan patterns to the fine anatomic structures relevant in glaucoma diagnostics, according to a company news release.

By means of a new proprietary technology called the Anatomic Positioning System, the module creates an anatomic map unique to each patient’s eye using two fixed, structural landmarks: the center of the fovea and the center of Bruch membrane opening. All subsequent scan protocols are automatically oriented according to each eye’s unique anatomic map, enabling a precise examination of relevant structures over time.

Furthermore, the Glaucoma Module Premium Edition compares patients’ eyes to an age- and disc-size–adjusted reference database of healthy eyes representing the racial and ethnic mix of the US population, flagging small deviations that may be clinically relevant. This allows for a highly sensitive assessment of structural damage characteristic of glaucoma and a close monitoring of structural changes indicative of glaucomatous progression.

EYE-SYNC Device that Assesses Abnormal Eye Movement, a Common Deficit After Concussion, Gains FDA Clearance

SyncThink announced the FDA clearance for its first medical device, Eye-Sync, an integrated head-mounted eye-tracking device for rapid recording, viewing, and analyzing of eye movement impairment through the use of virtual reality, according to a company news release. Abnormal eye movement is one of the most common deficits after a concussion occurs, an assessment Eye-Sync yields in under 60 seconds.

Eye-Sync uses high-performance eye-tracking technology to monitor eye movement in a handheld virtual reality environment. If your brain is out of sync after an incident, Eye-Sync can notify the trainer in less than a medical timeout. In collaboration with the Brain Trauma Foundation, SyncThink has developed an eye tracking assessment that measures accurate tracking of predictable visual target motion, an essential brain function. 

Noninvasive Technology That Visualizes Blood Vessels of the Retina Available in United states

Optovue announced FDA clearance and immediate US commercial availability of the AngioVue Imaging System, a groundbreaking technology that provides a non-invasive way to visualize abnormal blood vessels in the retina to help physicians determine an appropriate course of treatment.

“We are thrilled to announce FDA clearance of our AngioVue System, which will bring significant benefits of our innovative, noninvasive retinal imaging to patients in the US suffering from retinal diseases that lead to progressive blindness,” said Jay Wei, founder and CEO at Optovue. “Since we first introduced this technology to markets outside the US 14 months ago, the technology is in daily clinical use at over 525 clinical sites where it provides a more patient-friendly approach to diseases of the retina that lead to progressive blindness.”

The AngioVue System, with its proprietary technology, provides physicians with a noninvasive, dyeless technique for quickly visualizing the presence or absence of flow in the blood vessels. This enables the assessment of new information from the microvasculature and perfusion in ocular diseases detail.

Optovue is the first company to develop and commercialize this pioneering OCTA technology. Utilizing light rays to form detailed three-dimensional images of the retina, physicians are able to quickly visualize the blood vessels. In less than three seconds, the AngioVue System acquires a single image that complements the current angiography imaging standard, fluorescein angiography, but with a number of advantages. Unlike FA, the AngioVue System does not require the use of dye injections, which can often obscure the target anatomy and can lead to side effects and other complications associated with dye-based, invasive procedures.

The Oculus Pentacam AXL with Optical Biometry Receives FDA Clearance

The new Oculus Pentacam AXL has received 510(k) clearance from the FDA. The device is capable of anterior segment tomography and optical biometry with a single measuring operation, according to a company news release.

The intuitive and network-compatible IOL calculation software offers solutions to nearly every challenge. Standard formulas, such as formulas for treated corneas, toric IOLs, and ray-tracing formulas, are already integrated. The calculation of toric IOLs is based on the total corneal refractive power, thus taking the influence of the posterior corneal surface into account. A comprehensive IOL database with IOL constants for the Pentacam AXL is also integrated, according to Oculus.

The Pentacam AXL offers a well-targeted screening process, fast screening report, Belin/Ambrósio enhanced ectasia display (early detection of corneal ectasia) and densitometric evaluation (corneal optical densitometry and Pentacam Nucleus Staging) for every cataract patient. Whether aspherical, toric or multifocal, with the cataract preoperative display, the premium IOL can be selected in four steps.

In addition, the IOL constants optimization from Prof. Wolfgang Haigis allows continuous enhancement of the results. Surgical data and postrefractive examination findings are secured with just a few clicks.

Nidek Receives FDA 510(k) Clearance for the GYC-500/GYC-500 Vixi Green Scan Laser Photocoagulator

Nidek announced that the FDA has issued 510(k) clearance for the GYC-500/GYC- 500 Vixi Green Scan Laser Photocoagulator. With the clearance, the device is now available in the United States.

The GYC-500/GYC-500 Vixi is a solid state green laser that achieves stable treatment outcomes for multiple applications including retinal photocoagulation, trabeculoplasty, and iridotomy. This multifunction laser is housed in a small console. The 5.7-inch color touchscreen LCD includes an intuitive graphic user interface for quick and easy setup and verification of treatment parameters, according to a company news release.

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A wide range of selectable delivery units are available for the GYC-500/GYC-500 Vixi. In addition to conventional single delivery units, scan delivery units are added to a wide range of green laser delivery systems. Incorporating Vixi scan delivery units into the GYC-500 enables laser treatments with various scan patterns. The GYC-500 Vixi has 22 preprogrammed scan patterns to allow treatment of varying retinal pathologies, enhancing treatment efficiency and reducing patient chair time.

The user-friendly features and wide range of delivery options incorporated in the GYC-500/GYC-500 Vixi allow versatility for in-office use and the surgical suite, according to Nidek.

FDA Approves VisuMax Femtosecond Laser to Surgically Treat Myopia

Ophthalmologists in the United States will have an entirely new option in the surgical treatment of myopia as the FDA announced the approval of the VisuMax Femtosecond Laser ReLEx SMILE procedure. The VisuMax, manufactured by Carl Zeiss Meditec, is now indicated for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate myopia in certain patients 22 years of age or older.

Pivotal study results submitted to the FDA in Zeiss’ premarket approval application demonstrated excellent visual acuity and refractive predictability outcomes for the 336 eyes treated at five investigational sites in the United States. According to the FDA, a clinical study of the safety and effectiveness of the device to correct nearsightedness found the procedure resulted in stable vision correction at 6 months. Of the 328 participants evaluated at 6 months, all but one had uncorrected visual acuity of 20/40 or better, and 88% had uncorrected visual acuity of 20/20 or better. Complications during surgery included difficulty removing the corneal tissue and loss of suction that keeps the laser aligned with your eye. Complications after surgery included debris at the site of tissue removal, dry eye, moderate to severe glare and moderate to severe halos, according to the FDA.

SMILE is a minimally-invasive corneal refractive procedure and is currently available in about 500 clinics in 61 countries around the world. More than a half a million SMILE procedures have been performed internationally since its introduction in 2011.

Israeli-Made Therapeutic Contact Lenses Receive FDA Approval

The FDA has approved a new therapeutic contact lens that will help treat corneal edema, a common eye condition in adults that causes swelling, a build-up of fluid, blurred vision, haziness and scarring. EyeYon, the Israeli company responsible for this development, created these special lenses in an effort to increase the amount of time eye drops can remain in the eye in order to help alleviate symptoms of the condition which is common after cataract and corneal transplant surgeries. 

Advanced Vision Technologies Receives FDA Clearance for EyePrintPRO

Advanced Vision Technologies has announced the FDA clearance for manufacturing the EyePrintPro prosthetic scleral device and the proprietary EyePrint Impression Process. The EyePrint Impression Process creates an exact 3-D model of the ocular surface, which, in combination with the EyePrint Designer software, develops a unique and precise scleral device for protection and optical correction of the eye.  

“The patent-pending EyePrint Designer software utilizes proprietary Elevation Specific Technology enabling 360° of perfect alignment of the EyePrintPro haptic landing zone, achieving unparalleled comfort, vision and ocular health for the most highly irregular and diseased corneal conditions,” Keith Parker, president of Advanced Vision Technologies, said in a company news release.

“The EyePrintPro is exclusively manufactured by Advanced Vision Technologies and is proudly featured in the Optimum Extra 100Dk Contamac GP material. The EyePrintPro, developed by EyePrint Prosthetics, is available through trained EyePrint practitioners at EyePrint referral sites.”

Avedro Receives Long-Awaited FDA Approval for its Cross-Linking Platform for Progressive Keratoconus

Avedro received approval from the FDA for its corneal collagen cross-linking (CXL) platform, the KXL System, along with two photoenhancers—Photrexa Viscous and Photrexa—indicated for the treatment of progressive keratoconus. Photrexa Viscous, Photrexa, and the KXL System represent a first-in-class therapeutic treatment for this indication, according to Avedro.

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“I’m very happy that the FDA has finally approved corneal collagen cross-linking for progressive keratoconus. Patients with keratoconus (in the United States) finally have an FDA-approved treatment that is effective at stopping the progression of their disease, and we also typically see improvement in corneal shape and improvement in vision. So I think this is very exciting for patients who have keratoconus, and I’m hoping that this will also help with early detection of patients with keratoconus as more practitioners will be aware of this disease,” William B. Trattler, MD, director of cornea at the Center for Excellence in Eye Care in Miami, said in an interview with EyewireTV.

The approval was based on Avedro’s new drug application submission, which encompasses data from three prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials conducted in the United States to determine the safety and effectiveness of Photrexa Viscous and Photrexa when used for performing CXL in eyes with progressive keratoconus. Study 1 enrolled 58 patients with progressive keratoconus, and study 2 enrolled 147 patients with progressive keratoconus. In each study, patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye.

The cross-linked eyes showed increasing improvement in Kmax from month 3 through month 12. Kmax is defined as the maximum corneal curvature and measured in diopters. Progressive keratoconus patients had an average Kmax reduction of 1.4 D in study 1 and 1.7 D in study 2 at month 12 in the cross-linked eyes, while the untreated eyes had an average increase of 0.5 D in study 1 and 0.6 D in study 2 at month 12; the difference (95% CI) between the cross-linked and untreated groups in the mean change from baseline Kmax was -1.9 (-3.4, -0.3) D in study 1 and -2.3 (-3.5, -1.0) D in study 2, according to Avedro.

Ulcerative keratitis can occur, and patients should be monitored for resolution of epithelial defects, according to Avedro. In clinical studies, the most common ocular adverse reactions in any cross-linked eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

Avedro’s CXL Platform Approved by FDA for Corneal Ectasia Following Refractive Surgery

Avedro has received approval from the FDA for its CXL platform for the treatment of corneal ectasia following refractive surgery. The approval marks the second indication for Avedro’s photoenhancers Photrexa Viscous and Photrexa, used in conjunction with the KXL System. Avedro received an initial indication for the treatment of progressive keratoconus in April, and remains the first and only CXL therapy approved in the United States.

“We are pleased to be able to expand the clinical utility of our first-in-class [CXL] technology to another indication,” Rajesh Rajpal, MD, Chief Medical Officer for Avedro, said in a company news release. “The American Academy of Ophthalmology’s Preferred Practice Pattern for corneal ectasia endorses this approach and emphasizes the importance of treating the condition in its early stages. Since our initial launch in April, we’ve enjoyed an enthusiastic reception from the ophthalmic community and have been busy filling orders for the KXL System. With the availability of our Photrexa products in early fall, clinicians will be able to begin treating their patients with either of these forms of corneal ectasia.”

The Photrexa formulations and the KXL System are expected to be available for qualifying patients through their ophthalmologists before the end of this year.

ReVision Optics Receives FDA Approval for the Raindrop Near Vision Inlay

ReVision Optics received FDA approval for the Raindrop Near Vision Inlay for the surgical correction of presbyopia. The Raindrop Near Vision Inlay is indicated to improve near vision by reshaping the anterior curvature of the cornea in presbyopic patients who have emmetropic refractions (+1.00 D to -0.50 D). The Raindrop is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery, joining AcuFocus, which received FDA approval for the Kamra inlay in April 2015. The Raindrop is first FDA-approved implantable device that changes the shape of the cornea to achieve improved vision, according to the FDA.

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Results from the study submitted to the FDA in ReVision Optics’ premarket approval application showed clinically significant improvement in near visual performance, including:

Average uncorrected near visual acuity (UCNVA)improved by 5 lines on a standard eye chart (at 40 cm) in the treated eye. There was no loss in binocular distance vision.

Ninety-eight percent of patients achieved UCNVA of 20/40 or better and 88% of patients achieved UCNVA of 20/25 or better at 24 months in the treated eye.

The mean UCVA for both eyes exceeded 20/20 at all distances: near, intermediate, and distance.

In an exclusive interview with Eyewiretoday.com, John Kilcoyne, ReVision Optics President and Chief Executive Officer, credited the commitment of both the FDA and the company for the approval.

“They (the FDA representatives) were asking a lot of challenging questions and apprehensive questions. They were very forthright, and had good interaction with us. They struck a really good balance between pre- and postmarket requirements, so I would give the agency a lot of credit,” Mr. Kilcoyne said. “It was a good cooperative effort between the company and the agency. We provided them extremely comprehensive responses to their questions, and at the end of the day, what we reported was really solid data.”

“A huge amount of credit should be given to the (ReVision Optics) team for an outstanding job from the development, to the clinical trial, and then obviously through the regulatory process,” Mr. Kilcoyne added. “It’s a great milestone for the company.”

FDA Clears Sensimed Triggerfish Electronic Contact Lens

The FDA has cleared the Sensimed Triggerfish, a one-time use contact lens that may help practitioners identify the best time of day to measure a patient’s IOP.

The Triggerfish has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye’s volume. The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. A portable data recorder worn by the patient receives information from the antenna and can transfer the data via Bluetooth to the clinician’s computer, which shows the range of time during the day the pressure of the eye may be increasing. The device does not actually measure IOP, is not intended to be a diagnostic tool, and is not used to correct vision. 

“I think there’s a very strong interest from the ophthalmic community on eye-sensing devices. So I don’t see [the Triggerfish] as just a specific device approval, I see it as we’ve created a whole new category of which Triggerfish is the first. We intend to build on that ourselves. And we’ve obviously paved the way for others,” David Bailey, CEO of Sensimed, of Lausanne, Switzerland, said in an interview with Eyewiretoday.com.

“Sensimed has overcome both the technical and clinical barriers to actually get an FDA approval and create a new category in doing so. I think that’s quite significant.”

The Triggerfish is indicated for use in adults age 22 and older under the direction and supervision of a health care professional. Clinical data supporting the marketing authorization of the Triggerfish included several studies of the safety and tolerability of the contact lenses and the effectiveness of the device measurement. The effectiveness of the device was demonstrated by showing an association between the Triggerfish device output and IOP fluctuation. The most common temporary side effects were pressure marks from the contact lens, ocular hyperemia, and punctate keratitis.

The FDA reviewed the data for the Triggerfish through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

“We do not intend to actively commercialize the device at the moment,” Mr. Bailey said. “What we intend to do is to build on that initial approval and that initial indication to launch a longitudinal study in the area of ‘fast’ versus ‘slow’ progression … with the aim of expanding indications and hopefully providing a tool with a completely new measurement—ocular volume change—that the doctor can use to identify at-risk patients for progression. n