News Article | February 22, 2017
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, today announced that L. Jay Katz, MD, FACS, has joined the company as Chief Medical Officer. Dr. Katz is currently a practicing ophthalmologist, the Director of Glaucoma Service at Wills Eye Hospital in Philadelphia and a Professor of Ophthalmology at Jefferson Medical College at Thomas Jefferson University. In addition, he has authored numerous books on ophthalmology, published more than 200 articles in ophthalmic journals and is on the editorial board for Journal of Glaucoma, Survey of Ophthalmology, Graefe’s Archives of Clinical and Experimental Ophthalmology and The Open Ophthalmology Journal. After receiving his MD degree from Yale University Medical School in 1979, Dr. Katz completed an internship in internal medicine at the University of Virginia, a residency in ophthalmology at Yale and a fellowship in glaucoma at Wills Eye Hospital. Dr. Katz is actively involved in numerous ophthalmic professional organizations and glaucoma foundations. He is a former member of the board and past treasurer of the American Glaucoma Society, a diplomate and associate examiner for the American Board of Ophthalmology and a fellow, member-at-large and past president of the Philadelphia Metro chapter of the American College of Surgeons. “We are delighted and honored to welcome Dr. Katz to our senior leadership team,” said Thomas Burns, Glaukos President and Chief Executive Officer. “As evidenced by his many professional accomplishments and contributions to the practice of medicine, Dr. Katz is among the world’s foremost experts on glaucoma. We are confident that he will play an integral role in helping Glaukos continue to pioneer the worldwide development and expansion of Micro-Invasive Glaucoma Surgery, or MIGS.” A former medical monitor for various Glaukos clinical trials, Dr. Katz has also been an investigator in landmark glaucoma trials, including the Advanced Glaucoma Intervention Study (AGIS) and Collaborative Initial Glaucoma Treatment Study (CIGTS). In his role as Glaukos Chief Medical Officer, Dr. Katz’s responsibilities will include providing input and counsel on product development, clinical trial designs and surgeon training; overseeing global post-market medical safety programs; and collaborating with academic institutions, professional societies, cooperative groups and other strategic and scientific entities focused on the understanding and advancement of glaucoma patient care. “Glaucoma is an insidious, asymptomatic disease that causes vision loss in millions of people worldwide,” said Dr. Katz. “I have long admired and appreciated the innovative work Glaukos is undertaking to provide new, viable treatment options for glaucoma patients and the surgeons who care for them. I look forward to beginning the next phase of my career as part of the Glaukos organization as it continues to build MIGS awareness and adoption across the clinical community while also pursuing a range of promising next-generation therapies.“ In this new role, Dr. Katz will initially be employed by Glaukos on a part-time basis, while maintaining his ophthalmology practice in Philadelphia and involvement with clinical research and medical education. Glaukos (www.glaukos.com) is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world’s leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in July 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company believes the iStent, measuring 1.0 mm long and 0.33 mm wide, is the smallest medical device ever approved by the FDA. All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitations, our ability to continue to pioneer the worldwide development and expansion of MIGs and products for the treatment of glaucoma. These risks, uncertainties and factors are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Milman T.,New York Eye and Ear Infirmary |
Schear M.J.,New York Institute of Technology |
Eagle Jr. R.C.,Wills Eye Hospital
Ophthalmology | Year: 2014
Purpose To determine the efficacy of adipophilin immunohistochemistry in the diagnosis of sebaceous carcinoma of the ocular adnexal region and to provide the guidelines for interpretation of this immunostain. Design Retrospective, histopathologic case series. Participants A total of 25 patients with sebaceous carcinoma, 21 patients with basal cell carcinoma, 22 patients with conjunctival squamous cell carcinoma, 9 patients with cutaneous squamous cell carcinoma, and 5 patients with conjunctival mucoepidermoid carcinoma. Methods Immunohistochemical staining for adipophilin was performed on paraffin-embedded tissues and correlated with hematoxylin-eosin, periodic acid-Schiff (PAS), and mucicarmine-stained preparations. Immunostaining was quantified by light microscopy and with a computerized image analysis system of scanned images. Statistical analysis was performed to compare immunostaining patterns within the tumor categories by stage and grade, between the different neoplasms, and for correlation between light microscopy observations and computerized image analysis. Main Outcome Measures Localization of adipophilin immunostain, intensity of immunostaining, percent of immunoreactive cells, percentages of vacuolar staining and granular staining, and vacuole size. Results Adipophilin expression was observed in 100% of sebaceous carcinomas, 100% of cutaneous squamous cell carcinomas, 95% of basal cell carcinomas, 73% of conjunctival squamous cell carcinomas, and 60% of mucoepidermoid carcinomas. Sebaceous carcinomas demonstrated significantly stronger adipophilin expression, a greater number of intracytoplasmic vacuoles, and larger vacuoles. The specificity and sensitivity of adipophilin immunostaining in the diagnosis of sebaceous carcinoma were both 100% when more than 5% of the staining occurred in vacuoles (<95% granular staining). The diagnostic sensitivity and specificity were 100% and 96%, respectively, when the staining was graded as moderately or strongly intense and were 92% and 85% when the vacuoles were greater than 1.5 μm in diameter. Conclusions Although upregulation of neoplastic steatogenesis is observed in both sebaceous and nonsebaceous carcinomas, the pattern and intensity of adipophilin immunostaining are helpful in distinguishing sebaceous carcinoma from other neoplasms with overlapping histology. © 2014 by the American Academy of Ophthalmology Published by Elsevier Inc.
News Article | November 9, 2016
Diopsys, Inc. helps bring ERG testing out of the research lab and into clinical practice with a user- and patient-friendly sensor that produces reliable data. The latest advancement in electrode technology, the patented Diopsys® ERG Lid Sensor has transformed the eye care professional’s ability to perform reliable electroretinography (ERG) vision tests in their offices. The innovative sensor has a low-profile design which fits comfortably below the patient’s eye, and provides equivalent, and in some cases better results than previous electrodes. Previously available sensors can make it difficult for eye care professionals to perform accurate ERG tests in their offices and usually involve a contact lens or wire being placed across the eye, which increases the potential for damage to the cornea. These invasive electrodes often require pre-application numbing eye drops and post-sterilization between patients. Not only is this inconvenient to the clinician and uncomfortable for the patient, it can lead to compliance issues and poor results due to the excessive blinking caused by the electrode touching the eye. In some instances, the problems caused by invasive sensors have led to the use of generic skin electrodes, often designed for electromyography (EMG) or electrocardiography (EKG). The large size of these sensors often results in contact with facial muscles, which can produce inaccurate results. The Diopsys® ERG Lid Sensor was specifically designed for ERG testing to address the flaws of other electrodes. “The fact that we now have an ERG electrode that our patients are happy with, our technicians are happy with, and that provides excellent ERG results allows us to get information about the retina that we couldn’t have before. The Diopsys lid sensor technology certainly revolutionized our ability to detect disease earlier and monitor treatment and disease progression with ERG testing,” said Mitchell Jackson, MD, Founder and CEO of Jacksoneye. The patented Diopsys® ERG Lid Sensor underwent extensive development and design testing with leaders in the eye care field, including New York Eye and Ear Infirmary, Wills Eye Hospital, and Salus University. Research presented at the 2016 Association for Research in Vision and Ophthalmology (ARVO) meeting showed that the Diopsys® ERG Lid Sensor produces more repeatable amplitude results, and equivalent latency results compared to the older DTL and Ag/AgCl cup electrodes. Additional research using this advanced lid sensor technology showed the test-retest repeatability of Diopsys® ERG and Diopsys® ffERG vision tests ranged between good and excellent for all tested parameters. For more information on Diopsys® ERG vision testing, please visit http://www.diopsys.com/erg. About Diopsys Diopsys, Inc. (http://www.diopsys.com) is the leader in providing ophthalmologists and optometrists with objective, functional information to aid in the early detection of vision disorders and enhance patient management through ERG and VEP vision testing. Eye care providers can perform these objective, functional tests using the Diopsys® NOVA cart system, or the Diopsys® ARGOS™ tabletop system. The company understands the important role of early medical intervention for correctable vision problems, which can lead to an improved quality of life. Early detection means better patient outcomes. 1. Shengelia A. et al. Evaluation of pattern ERG responses using various electrodes. Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3943. 2. Resende A. et al. Repeatability of Steady-State Pattern Electroretinogram and Full-Field Electroretinogram using a novel office-based testing platform in normal subjects. Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3949.
Schubert C.,Wills Eye Hospital |
Van Langeveld M.C.,University of Utah |
Donoso L.A.,Wills Eye Hospital
British Journal of Ophthalmology | Year: 2014
3D printing is a method of manufacturing in which materials, such as plastic or metal, are deposited onto one another in layers to produce a three dimensional object, such as a pair of eye glasses or other 3D objects. This process contrasts with traditional ink-based printers which produce a two dimensional object (ink on paper). To date, 3D printing has primarily been used in engineering to create engineering prototypes. However, recent advances in printing materials have now enabled 3D printers to make objects that are comparable with traditionally manufactured items. In contrast with conventional printers, 3D printing has the potential to enable mass customisation of goods on a large scale and has relevance in medicine including ophthalmology. 3D printing has already been proved viable in several medical applications including the manufacture of eyeglasses, custom prosthetic devices and dental implants. In this review, we discuss the potential for 3D printing to revolutionise manufacturing in the same way as the printing press revolutionised conventional printing. The applications and limitations of 3D printing are discussed; the production process is demonstrated by producing a set of eyeglass frames from 3D blueprints.
Gunton K.B.,Wills Eye Hospital
Current Opinion in Ophthalmology | Year: 2015
Purpose of review There are many surgical options to address a sixth nerve palsy including transpositions of the vertical recti to the lateral rectus. This review will summarize the results from variations on transpositions as they apply to sixth nerve palsies. Recent findings Transposition of both vertical recti with posterior fixation creates the greatest correction of esotropia in primary position with largest field of single vision. Transposition of the superior rectus alone preserving anterior segment circulation achieves effects similar to transposition without posterior fixation. Augmentation with partial transposition also creates similar improvement in esotropia with possibilities for adjustable sutures and circulation preservation. Summary These various options on transpositions allow options to specifically address surgeon preferences and patient needs to select the appropriate surgery. Copyright © 2015 Wolters Kluwer Health, Inc.
Freidl K.B.,Wills Eye Hospital |
Moster M.R.,Wills Eye Hospital
Survey of Ophthalmology | Year: 2012
It is important to equip future ophthalmic surgeons with appropriate surgical skills without compromising patient care. The ExPRESS implant surgery is very similar to trabeculectomy surgery in both efficacy and technique, but is less traumatic and may be prone to less postoperative hypotony and require less postoperative hypotensive medications. although affording a way to teach a novice surgeon the steps and technique of trabeculectomy and minimizing patient risk, ExPRESS implantation is a more expensive surgery that involves placing a foreign body in the eye. Further, needling an ExPRESS is a more technically challenging procedure than needling a trabeculectomy and more limited in its scope. © 2012 Elsevier Inc..
Haller J.A.,Wills Eye Hospital
Survey of Ophthalmology | Year: 2014
Scientific collaboration between academia and industry has a long history in the United States and abroad. Initially U.S. companies took responsibility for patenting and licensing discoveries made in collaborating universities. A publicly funded "middle man", The Research Corporation, was the next paradigm and had the advantages of neutrality and centralization, but proved ultimately unworkable. More recently, universities have negotiated their own patenting and licensing activities. The ethical pitfalls of scientists and physicians dealing directly with industry stimulated much public discussion in the past decade, with a resultant backlash discouraging collaboration. I discuss this evolution, and recent developments with models of possible productive collaboration and rules of engagement. © 2014 Elsevier Inc.
Feldman B.H.,Wills Eye Hospital
Survey of Ophthalmology | Year: 2015
The femtosecond laser was recently introduced to cataract surgery in order to replace several highly successful and low risk manual surgical techniques with automated laser techniques. Despite the hope that femtosecond laser-assisted cataract surgery (FLACS) would lead to safer and more predictable surgical outcomes, the literature consistently demonstrates that FLACS has provided no advantage over standard phacoemulsification cataract surgery (SP). Yet, the disadvantages of FLACS as compared to SP are clear. FLACS is more expensive and time-consuming, may increase surgical complications during the surgeon's initial learning period, introduces unique risks due to the additional steps of laser docking and treatment, and is limited in its scope of use as compared to SP due to factors including small pupils and orbital anatomy. While FLACS may one day prove to be advantageous for a small subset of patients, such as those with corneal endothelial cell dysfunction or zonular instability, these patients have not been the targets of this technology, and FLACS will not become the standard technique for cataract extraction in the coming decade. © 2015 Elsevier Inc.
Capasso J.E.,Wills Eye Hospital
Current Opinion in Ophthalmology | Year: 2014
Purpose of Review: To facilitate ophthalmologists' understanding on the cost of genetic testing in ocular disease, the complexities of insurance coverage and its impact on the availability of testing. Recent Findings: Many insurance carriers address coverage for genetic testing in written clinical policies. They provide criteria for medically necessary testing. These policies mostly cover testing for individuals who are symptomatic and in whom testing will have a direct impact on medical treatment. In cases in which no treatments are currently available, other than research trials, patients may have difficulty in getting insurance coverage for genetic testing. Summary: Genetic testing for inherited eye diseases can be costly but has many benefits to patient care, including confirmation of a diagnosis, insight into prognostic information, and identification of associated health risks, inheritance patterns, and possible current and future treatments. As gene therapy advances progress, the availability for treatment in ocular diseases, coverage for genetic testing by third-party payers could increase on the basis of current clinical policies. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Gunton K.B.,Wills Eye Hospital
Current Opinion in Ophthalmology | Year: 2014
Purpose of Review: Adult strabismus can cause many symptoms, which have generally been divided into functional complaints and social complaints. The validity of surgical correction has historically been based on the restoration of functional improvement. In the absence of this expectation, surgery was labeled cosmetic. Yet, many studies have revealed the immense impact of ocular misalignment on psychosocial variables. The purpose of this article is to review the potential functional and psychosocial benefits of strabismus surgery and to summarize the development and status of questionnaires to help quantify these benefits. Recent Findings: Functional benefits of strabismus surgery have been recently summarized with a meta-analysis. Several questionnaires have been evaluated to assess the functional and psychosocial factors in adult strabismus. Two strabismus-specific questionnaires, the Amblyopia and Strabismus Questionnaire and the Adult Strabismus-20, reveal improvements in adults following surgery. The appropriate patient population, impact of comorbidities on the scores, and the timing of the administration of the questionnaire postoperatively still need to be determined. Summary: Future studies of the impact of strabismus surgery in adults will need to report not only objective motor results, but also the impact on health-related quality of life to encompass all the benefits of strabismus surgery. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.