A weekly e-journal by Art Epstein, OD, FAAO


Volume 14, Number 41

Monday, October 13, 2014


In this issue: (click heading to view article)
######### Off the Cuff: These Are a Few of My Favorite MGD Things

######### Assessment of Choroidal Thickness in Healthy and Glaucomatous Eyes Using OCT
######### Assessment of Ocular Biomechanics Using Dynamic Ultra High-Speed Scheimpflug Imaging in Keratoconic and Normal Eyes
######### Sex-Steroid Imbalance in Females and Dry Eye
######### News & Notes

Click on the image for upcoming Conferences and Meetings.


Off the Cuff: These Are a Few of My Favorite MGD Things

Last week, I shared my current thinking on dry eye. I received a ton of email and while I will answer everyone individually, many colleagues asked me to elaborate on what I do in my own practice.

Treating MGD effectively requires raising the temperature of the meibomian glands sufficiently to melt congealed meibum, then expressing the stagnant contents of the glands. There are several ways to elevate the temperature. The most effective is by applying heat to the inside of the eyelid—the technique used by TearScience's LipiFlow device. The least effective way is by using the classic warm compress, which cools too quickly and loses most of its heat to blood vessels in the lid.

LipiFlow auto-expresses the glands. Manual expression can be accomplished using a Mastrota paddle and finger pressure, or a variety of specially designed forceps such as the Arita Meibomian Gland Compressor. I've found warming the lids first to be helpful.

Lid margin debridement can dramatically improve the effectiveness of expression and should be repeated every six months. I now use the BlephEx by Rysurg for debridement as well as for treating blepharitis. Manual debridement can also be accomplished using a golf club spud

Recently, I've come to understand that restoring meibomian gland lipid production can be undone by the activity of lipases and soaps produced by excessive Staph on the lid margins. I now have all MGD patients use i-Lid Cleanser by NovaBay, which is antimicrobial and also inactivates bacterial toxins and enzymes.

Dry eye is complex and no single cause or cure exists. However, these few favorite things have helped me make a difference in my patients' lives.

Arthur B. Epstein, OD, FAAO
Chief Medical Editor


Want to share your perspective? Write to Dr. Epstein at artepstein@optometricphysician.com.

The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of the editorial board, Jobson Medical Information LLC (JMI), or any other entities or individuals.




Assessment of Choroidal Thickness in Healthy and Glaucomatous Eyes Using OCT
A cross-sectional observational study of 216 eyes of 140 subjects with glaucoma and 106 eyes of 67 healthy subjects enrolled in the Diagnostic Innovations in Glaucoma Study to evaluate choroidal thickness (CT) in healthy and glaucomatous eyes using swept-source optical coherence tomography (SS-OCT). CT was assessed from wide-field (12x9 mm) SS-OCT scans. The association between CT and potential confounding variables including age, gender, axial length, intraocular pressure, central corneal thickness and ocular perfusion pressure was examined using univariable and multivariable regression analyses.

Overall, CT was thinner in glaucomatous eyes with a mean (± standard deviation) of 157.7 ± 48.5 µm in glaucoma compared to 179.9 ± 36.1 µm in healthy eyes (p<0.001). The choroid was thinner in both the peripapillary and macular regions in glaucoma compared to controls. Mean peripapillary CT was 154.1 ± 44.1 µm and 134.0 ± 56.9 µm (p<0.001) and macular CT 199.3 ± 46.1 µm and 176.2 ± 57.5 µm for healthy and glaucomatous eyes respectively. However, older age (p<0.001) and longer axial length were also associated with thinner choroid and when differences in age and axial length between glaucomatous and healthy subjects were accounted for, glaucoma was not significantly associated with CT. There was also no association between glaucoma severity and CT.

Glaucoma was not associated with CT measured using SS-OCT; however, older age and longer axial length were associated with thinner choroid so should be considered when interpreting CT measurements.

SOURCE: Zhang C, Tatham AJ, Medeiros FA, et al. Assessment of choroidal thickness in healthy and glaucomatous eyes using swept source optical coherence tomography. PLoS One. 2014; Oct 8;9(10):e109683.



Assessment of Ocular Biomechanics Using Dynamic Ultra High-Speed Scheimpflug Imaging in Keratoconic and Normal Eyes
This article introduces several new ocular biomechanical parameters for comparison between keratoconic and normal eyes using an analysis method based on corneal dynamic deformation video recorded by corneal visualization Scheimpflug technology (Corvis ST; Oculus Optikgeräte GmbH). This comparative study comprised 52 keratoconic eyes of 43 patients with keratoconus and 52 normal eyes of 52 controls. An analysis method (PolyU [Labview 2009; National Instrument]) was developed to introduce several new ocular biomechanical parameters and to compare the difference between keratoconic and normal eyes. The repeatability of the new parameters measurement was evaluated and compared with the Corvis ST measurement. Receiver operating characteristic curves were used to establish a cutoff value for the new biomechanical parameters.

Intraclass correlation coefficients of the deformation amplitude, peak distance, corneal concave radius of curvature, maximum deformation area, maximum corneal inward velocity and outward velocity (Vin, max and Vout, max) were high in both the keratoconic and normal eyes (all intraclass correlation coefficients >0.75). The measurement agreement of the PolyU analysis method and Corvis ST was good. Most of the biomechanical parameters of patients with keratoconus were significantly different from those of the controls. In the receiver operating characteristic analysis, the Vin, max was the best predictive parameter with an area under the curve of 0.79.

The corneal deformation video recorded by the Corvis ST provides useful information for the study of ocular biomechanics. Most of the new ocular biomechanical parameters were significantly different between keratoconic and normal eyes. Further research is needed to develop more comprehensive clinical applications with these new ocular biomechanical parameters.

SOURCE: Tian L, Ko MW, Wang LK, et al. Assessment of ocular biomechanics using dynamic ultra high-speed scheimpflug imaging in keratoconic and normal eyes. J Refract Surg. 2014; Oct 7:1–7. [Epub ahead of print].



Sex-Steroid Imbalance in Females and Dry Eye
Dry eye is a multifactorial disorder of the ocular surface unit that results in eye discomfort, visual disturbance and ocular surface damage. It is one of the most common complaints in daily ophthalmic practice. The risk of dry eye increases with age in both sexes, while its incidence is higher among females. In addition, the condition of menopause in aging women may also contribute to dry eye onset or worsening as a consequence of an overall hormonal imbalance.

Sex hormones play a key role in ocular surface physiology and they impact differently on ocular surface tissues. Reduced estrogen levels were historically thought to be responsible in age-related dry eye onset, but more recent investigations have reconsidered the role of androgens that are present and exert a protective function on the ocular surface. Hormone levels themselves, withdrawal changes in hormone levels and the changes in hormone-receptor responsiveness are all important factors, but it remains to be fully elucidated how estrogen or androgen insufficiency act alone or together in a combined imbalance or interplay to raise the risk of disease. The purpose of this review is to briefly outline current scientific evidence on the influence of androgens and estrogens, on the lacrimal and meibomian glands and on ocular surface epithelia including conjunctival goblet cells during reproductive and menopausal periods.

The role of sex steroids is also discussed in relation to the pathogenesis of different forms of dry eye and Sjögren's syndrome. The impact of systemic hormone therapy in dry eye post-menopausal women still appears as a controversial issue, despite the many clinical studies. Finally, the outcomes of topical applications of steroid-based products are summarized, underlying the need for potential (tear) biomarker(s) in the rationale of dry eye-targeted therapy.

SOURCE: Versura P, Giannaccare G, Campos EC. Sex-steroid imbalance in females and dry eye. Curr Eye Res. 2014; Oct 7:1–14. [Epub ahead of print].



News & Notes
FDA GRANTS PRIORITY REVIEW FOR LUCENTIS IN DIABETIC RETINOPATHY. Genentech, a member of the Roche Group, announced that the FDA has accepted to file the company's supplemental Biologics License Application, which was submitted on August 7, 2014 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. The FDA has also granted Priority Review of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy. The FDA confirmed action date is February 6, 2015. Find out more at www.gene.com.

PATENTS ISSUED FOR TWO OF ACIEX THERAPEUTICS' LEADING PRODUCT CANDIDATES. According to a recent news release from Aciex Therapeutics Inc., the United States Patent and Trademark Office (USPTO) has issued patents covering two of the company's product candidates: Patent No. 8,829,005, which contains method-of-treatment claims that cover AC-170 Cetirizine Ophthalmic Compositions and Patent No. 8,765,725, which contains both composition-of-matter and method-of-use claims that broadly cover AC-155 Fluticasone Propionate Nano-crystalline Compositions. AC-170 is a novel formulation of cetirizine (an oral antihistamine) being evaluated for the treatment of allergic conjunctivitis. AC-155 is a novel nanocrystalline form of fluticasone (a nasal corticosteroid) and is also being developed for the first time for topical ocular administration. It uses Aciex's proprietary manufacturing process and is being developed for postop inflammation and pain. Earlier this year in July, Nicox S.A. signed an agreement to acquire Aciex Therapeutics. The completion of the acquisition remains subject to the approval of Nicox's shareholders and other customary conditions.

ELEVEN BIOTHERAPEUTICS' EBI-005 RECEIVES U.S. COMPOSITION-OF-MATTER PATENT FOR TREATMENT OF OCULAR SURFACE INFLAMMATORY DISEASES. In a recent release issued to the press, Eleven Biotherapeutics Inc. announced the issuance of U.S. Patent No. 8,853,150 entitled “Chimeric Il-1 Receptor Type I Agonists and Antagonists,” which covers the composition-of-matter of Eleven's lead product candidate, EBI-005, a topically administered interleukin-1 receptor blocker, certain other compositions that are IL-1 receptor antagonists and related methods for treating ocular surface inflammatory diseases such as dry eye disease and allergic conjunctivitis. Designed, engineered and generated using Eleven's AMP-Rx platform, EBI-005 is being developed as a topical protein therapeutic for ocular diseases. Eleven recently reported top-line results of a Phase II study of EBI-005 in patients with moderate to severe allergic conjunctivitis and is currently evaluating EBI-005 in a pivotal Phase III clinical study in patients with dry eye disease, with top-line data expected in early 2015.

CELL CURE NEUROSCIENCES FILES IND FOR OPREGEN TO TREAT DRY AMD. BioTime Inc., HBL Hadasit Bio-Holdings Ltd. and Cell Cure Neurosciences Ltd. recently announced that Cell Cure has filed an Investigational New Drug application with the FDA seeking to initiate a Phase I/IIa clinical trial of OpRegen in patients with geographic atrophy. OpRegen consists of retinal pigment epithelial cells derived from human embryonic stem cells and is intended to be administered as a single dose into the subretinal space of patients' eyes to treat this leading cause of blindness. The design of the proposed clinical trial, “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy,” is based on a pre-IND meeting with the FDA and a series of earlier interactions with the agency. The study will explore three different doses of OpRegen. Following a single transplantation, patients will be followed over 12 months at specified intervals and then at longer time periods to evaluate the safety and tolerability of the product. A secondary objective of the clinical trial will be to explore the ability of transplanted OpRegen to engraft, survive and moderate the disease progression.

OPTOS COLLABORATING WITH NHS AND ACADEMIA ON EARLY DETECTION DEVICE FOR SIGHT-THREATENING DISEASES. Optos plc has announced a £10 million collaboration (~16,214,300 U.S. dollars) with scientists and clinicians from the National Health Service Greater Glasgow and Clyde, as well as the Universities of Kent and Strathclyde, for the development of a new imaging technology that could allow earlier detection of sight-threatening disease. An initial £1.1 million study, funded by Innovate UK and Optos, will develop a laser-based technology to monitor the function of the cells in the eye, which is expected to detect and monitor eye disease at a very early stage, enabling earlier intervention and better treatment regimens. The first clinical studies will focus on the leading causes of blindness: age-related macular degeneration, glaucoma and diabetic retinopathy, and are expected to be completed in the first half of 2017. If successful, a further £9 million will be invested to develop a fully licensed medical device for the NHS by 2018. Want to know more? Visit www.optos.com.

STAPLE PROGRAM HOLDS 100TH WORKSHOP FOR OPTOMETRY STUDENTS. The Soft Toric and Presbyopic Lens Education (STAPLE) Program recently held its 100th workshop at The Ohio State University. A collaborative effort on the part of Alcon; Bausch + Lomb; CooperVision; and Vistakon, Division of Johnson & Johnson Vision Care Inc., these workshops bring educators and industry together to provide second- and/or third-year optometry students with hands-on experience fitting soft toric and soft multifocal lenses on actual patients in a noncompetitive environment. Since the STAPLE Program held its first workshop in January 2012, nearly 7,000 student encounters have taken place in the 57 toric and 43 multifocal workshops. Learn more at www.stapleprogram.com.

TODD N. SMITH NAMED SENIOR VP AND CCO OF OPHTHOTECH CORP. Todd N. Smith has joined Ophthotech Corp. as senior vice president and chief commercial officer, a new position at the company. He will be responsible for developing and implementing Ophthotech's commercial strategy and establishing a commercial infrastructure of high-quality marketing, product access and sales teams. Mr. Smith has more than 20 years of pharmaceutical and biotechnology sales and marketing experience. He will report directly to Ophthotech's chief executive officer and chairman of the board, David R. Guyer, MD. He will also serve as a member of the company's senior leadership team.



Optometric Physician™ Editorial Board

Chief Medical Editor
Arthur B. Epstein, OD, FAAO

Journal Reviews
Shannon Steinhäuser, OD, FAAO

Contributing Editors
• Katherine M. Mastrota, MS, OD, FAAO
• Barry A. Weissman, OD, PhD, FAAO (Dip CL)

Editorial Board
• William Jones, OD, FAAO
• Alan G. Kabat, OD, FAAO
• Bruce Onofrey, RPh, OD, FAAO
• John Schachet, OD, FIOS
• Joseph Shovlin, OD, FAAO



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