From the editors of Review of Ophthalmology:
MAY IS HEALTHY VISION MONTH
In this issue: (click heading to view article)
Antidiabetic Drug Metformin Reduces Odds of Developing AMD?
Researchers wrote that studies suggest the antidiabetic drug metformin is associated with decreased risk of several ocular diseases, but no work has investigated the effect of metformin on the development of age-related macular degeneration. They aimed to investigate whether metformin use was associated with a decreased risk of developing AMD.
In this retrospective, case-control study, researchers used medical records from individuals older than 55 who visited a University of Florida health clinic. Three controls were matched for every AMD case—defined by the International Classification of Diseases, Ninth Revision code, based on the Charlson Comorbidity Index—to ensure comparable baseline overall health status. Univariate and conditional multivariable logistic regressions were used to determine the association between a variety of covariates, including metformin use, and AMD diagnosis.
Metformin use was associated with decreased odds of developing AMD, independently of the other covariates investigated (OR, 0.58; CI, 0.43 to 0.79). Other medications assessed weren’t associated with decreased odds of developing AMD.
Though researchers say that individuals who took metformin had decreased odds of developing AMD, they’re quick to add that further research should include clinical trials to investigate prospectively whether metformin actually has a protective effect.
Brown EE, Ball JD, Chen Z, et al. The common antidiabetic drug metformin reduces odds of developing age-related macular degeneration. Invest Ophthalmol Vis Sci. 2019;60:5:1470-7.
Long-term Results of Accelerated Corneal Cross-linking in Adolescents with Keratoconus
Investigators reported the long-term results of accelerated corneal collagen cross-linking treatment in those with progressive keratoconus in the pubertal period.
Those with progressive keratoconus ages 14 and younger were retrospectively reviewed. Thirty-five eyes of 23 adolescents, who were followed for at least four years postoperatively, were included. Demographic characteristics, uncorrected visual acuity, best-corrected visual acuity and corneal topography data were recorded. All participants underwent an epi-off accelerated corneal collagen cross-linking protocol.
The mean age of the participants was 13 ±0.5 (range: 11 to 14) years. Male to female ratio was 3:2. Here are some of the findings.
• The mean pupillary center to cone apex distance was 1.6 ±0.5 mm. At presentation, 11 eyes (31 percent) were classified as stage 1 keratoconus; 14 eyes (40 percent) were classified as stage 2 keratoconus, eight eyes (23 percent) were classified as stage 3 keratoconus and two eyes (6 percent) were classified as stage 4 keratoconus.
• The mean follow-up period was 56 ±8 months.
• At the first year of follow-up, central corneal thickness (p=0.02) and thickness of thinnest point of the cornea (TTPC) were decreased significantly compared with preoperative values (p=0.003).
• At the second year of follow-up, only TTPC decreased compared with preoperative values (p=0.01).
• At the last follow-up visit, CCT increased significantly compared with preoperative CCT (p=0.04).
Investigators determined that progression was found in 20 percent of eyes after an average follow-up of 56 months, despite appropriate treatment. By the last visit, progression was associated with K1, K2, CCT, TTPC and age.
SOURCE: Ozer MD, Batur M, Mesen S, et al. Long-term results of accelerated corneal cross-linking in adolescent patients with keratoconus. Cornea 2019; April 25. [Epub ahead of print].
Association Between VF Reliability Indices & Cognitive Impairment in Glaucoma Patients
This prospective cross-sectional study found that individuals with cognitive impairment were more likely to produce unreliable visual field tests, especially higher false-negative responses and consequent overestimation of mean deviation.
Scientists wrote that aging-associated cognitive impairment could impair the ability of individuals to perform VF tests and compromise the reliability of the results. They evaluated the association between neurocognitive impairment and VF reliability indices in individuals with glaucoma.
This study was conducted in the ophthalmology department of Hospital Kuala Pilah in Malaysia and included 113 eyes of 60 glaucoma patients with no prior diagnosis of dementia. Patients were monitored with the Humphrey VF analyzer using a 30-2 SITA, standard protocol and CI assessed using the clock drawing test (CDT). The relationships between the CDT score, mean deviation, pattern standard deviation (PSD), Visual Field Index (VFI), fixation loss (FL), false positive (FP) and false negative (FN) values were analyzed using the ordinal regression model. Here were some of the findings:
• Glaucoma patients older than 65 had a higher prevalence of CI.
• A statistically significant correlation was found between CDT scores and glaucoma severity (rs=-0.20; p=0.03), FL (rs=-0.20; p=0.04), FN (rs=-0.28, p=0.003) and VFI values (rs=0.21, p=0.03).
• In a multivariate model adjusted for age and glaucoma severity, patients with lower FN were significantly less likely to have CI (OR, 0.91; CI, 0.89 to 0.93), and patients with higher MD were more likely to have CI (OR, 1.10; CI, 1.05 to 1.16); FP, FL, PSD and VFI showed no significant correlation.
Scientists reported that cognitive decline was associated with reduced VF reliability, especially with higher FN rate and overestimated MD. They suggested that screening and monitoring of CI might be important in assessment of VF progression in glaucoma patients.
SOURCE: Raman P, Yeap KC, Premala Devi S, et al. The association between visual field reliability indices and cognitive impairment in glaucoma patients.
J Glaucoma 2019; Apr 24. [Epub ahead of print].
RRD Following Intravitreal Injection of Anti-VEGF
Researchers determined the rate, risk factors and outcomes of rhegmatogenous retinal detachment following intravitreal injection of anti-vascular endothelial growth factor medications, as part of a single-center, retrospective, consecutive review.
Participants included all individuals receiving ranibizumab, bevacizumab or aflibercept for neovascular age-related macular degeneration or retinal vein occlusion between Oct. 1, 2014, and Oct. 1, 2017.
The total number of eyes and injections were determined from billing codes. RRD cases were determined from billing records and confirmed with chart review. Main outcome measures included the rate of retinal detachment and visual acuity outcomes. A total of 180,671 intravitreal injections in 12,718 unique patients were included. Here were some of the findings:
• An RRD occurred in 24 patients within three months following injection, for a rate of one RRD per 7,532 intravitreal injections (0.013 percent) and one RRD per 530 patients (0.19 percent).
• No association was found between post-injection RRD risk and diagnosis (p=0.54), physician experience (p=0.23), injection site (p=0.41), caliper use (p=0.75) or 31- vs. 30-gauge needle use (p=0.18).
• A retinal tear was found in the quadrant of the injection site (within 1.5 clock hours of the injection) in 15 of 24 patients (62.5 percent; p<0.0001).
• At the time of RRD diagnosis, the macula was attached in nine cases (37.5 percent).
• Interventions for RRD repair included pars plana vitrectomy (15 cases), combined scleral buckle-PPV (four cases), pneumatic retinopexy (three cases) and laser/cryotherapy alone (two cases).
• The single-surgery success rate was 54.2 percent with 54.5 percent of recurrent detachments caused by proliferative vitreoretinopathy.
• Average loss from visual acuity recorded at the visit prior to diagnosis of RRD was one line for macula-on detachments vs. 6.8 lines for macula-off detachments (p=0.027) at final follow-up (average 16.3 months).
Researchers concluded that retinal detachment following intravitreal injection was uncommon with a rate of approximately one in 7,500 injections. They added that macular status at the time of RRD diagnosis significantly affected visual outcomes.
SOURCE: Storey PP, Pancholy M, Wibbelsman TD, Obeid A, Su D, Borkar D, Garg S, Gupta O. Rhegmatogenous retinal detachment following intravitreal injection of anti-vascular endothelial growth factor. Ophthalmology. 2019 Apr 28. [Epub ahead of print]
Zeiss Launches First Dual-Speed Swept-Source OCT/OCTA at ARVO Annual Meeting
Zeiss Medical Technology Segment launched the first dual-speed swept-source OCT/OCTA that will scan at 200kHz in addition to 100kHz. The PLEX Elite 2.0 enables faster, deeper and higher resolution imaging of the eye, the company says. Varying speeds can be applied to different disease states in the eye. Zeiss says that doctors can fully image conditions such as posterior staphylomas, retinal detachments, high myopia and choroidal tumors. This provides faster scans to visualize from the retina-vitreous interface to the choroid to assess highly curved myopic eyes in a new way, the company adds. Read more.
ImprimisRx Introduces New Formulations at ASCRS Meeting
At the American Society of Cataract and Refractive Surgery annual meeting in San Diego (May 3 to 7), attendees will have the opportunity to meet with ImprimisRx representatives at Exhibit #1427 to learn more about proprietary formulations launching this year, including:
• Klarity-A Drops (preservative-free ophthalmic solution + azithromycin 1%);
• Klarity-B Drops (preservative-free ophthalmic solution + betamethasone 0.1%);
• Klarity-L Drops (preservative-free ophthalmic solution + loteprednol 0.5%);
• LessDrops formulations with moxifloxacin; and
• Povidone Iodine 5%
J&J Vision Highlights New Data on Personalized Vision Approach at ASCRS/ASOA Annual Meeting, Showcases New Research at ARVO
Johnson & Johnson Vision says new data presented at two ophthalmology meetings will further support advancements and innovations in the treatment of cataracts, dry eye and laser vision correction. These analyses will be presented at the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators annual meeting (May 3-7). The company will feature interactive educational experiences for professionals including the Tecnis Experience, the LipiFlow Patient Experience Suite, the J&J Vision Learning Hub and more. The company is also sponsoring the seventh annual ASCRS Foundation Run for Sight. Read more.
In addition, the company showcased new research abstracts covering topics across a range of eye health needs at the Association for Research in Vision and Ophthalmology Annual Meeting in Vancouver, Canada (April 28 to May 2). Presentations included a predictive model for direct health and medical costs associated with myopia and related eye conditions around the world, as well as advanced study models that predict new levels of spectacle independence to evaluate intraocular lens designs. Read more.
FDA Warning: AmEx Pharmacy Issues Voluntary Nationwide Recall for Lot of Bevacizumab Syringes
AmEx Pharmacy says it voluntarily recalled “one lot of bevacizumab 1.25mg/0.05mL 31G injectable to the consumer/user level.” The FDA reported that the monoject syringe of this product might become difficult to express, and applying additional force while the needle is in the eye might cause injury to the patient. Read more.
B+L Announces Update From ARMOR Study
Bausch + Lomb announced that the results from nearly 10 years of the Antibiotic Resistance Monitoring in Ocular MicRoorganisms surveillance study (ARMOR) were presented at the ARVO annual meeting in Vancouver. The ARMOR study tracks in vitro antibiotic susceptibility profiles among ocular bacterial pathogens of significance. Researchers also presented preliminary 2018 surveillance data on antibiotic resistance levels. Initiated in 2009, ARMOR is the only ongoing multicenter survey of antibiotic resistance patterns specific to ocular pathogens in the United States, B+L notes. Read more.
Aerie Announces U.S. Launch of Rocklatan and Increase in Rhopressa Medicare Part D Coverage
Aerie Pharmaceuticals launched Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% in the United States glaucoma market. The company says national and regional U.S. pharmaceutical wholesalers now have Rocklatan, and patients can fill prescriptions through their local pharmacies across the nation. Additionally, effective May 1, Medicare Part D preferred tier coverage for Rhopressa (netarsudil ophthalmic solution) 0.02% increased from approximately 40 percent to 75 percent. Read more.
Santen & Glaukos Enter Into Agreement
Santen Pharmaceutical announced that Santen’s U.S. subsidiary entered into a multiyear agreement whereby Glaukos will become the exclusive distributor of the MicroShunt in the U.S. market. Santen says the MicroShunt is a novel, minimally invasive, ab-externo surgical device being developed for primary open-angle glaucoma. The device is being studied in an FDA trial for intraocular pressure reduction in individuals with POAG where intraocular pressure is uncontrolled with maximum tolerated medical therapy or where the progression of the disease warrants surgery. Read more.
New President/CEO at The Glaucoma Foundation
The Board of Directors of The Glaucoma Foundation appointed Elena Sturman as president and chief executive officer, following the retirement of Scott R. Christensen, who held the position since 2002. Sturman, who will begin her tenure on May 15, was most recently senior vice president and chief development officer at Phoenix House, a nonprofit drug and alcohol rehabilitation organization. Read more.
Avedro Completes Enrollment in Phase III Epi-on Cross-Linking Trial
Avedro announced that the company completed patient enrollment in a Phase III clinical trial to evaluate the safety and efficacy of an epithelium-on corneal cross-linking procedure for the treatment of progressive keratoconus. The trial, ACP-KXL-308, is a multicenter, randomized, sham-controlled study of a novel corneal cross-linking procedure that includes Avedro’s latest-generation UV light source, supplemental oxygen designed to enhance cross-linking and a new drug formulation designed to penetrate the epithelial layer of the cornea. The company also announced the inclusion of a wide range of corneal cross-linking and keratoconus scientific and educational programs at the American Society of Cataract and Refractive Surgery annual meeting. Read more.
Allegro to Present Results of ALG-1007 Trial at ASCRS
Following last week’s news that the company is expanding its pipeline into dry eye and has created a new Cornea Scientific Advisory Board, Allegro Ophthalmics announced that the results of its ALG-1007 proof-of-concept clinical trial for the treatment of dry eye disease, conducted outside of the United States, were to be presented during the ASCRS/ASOA annual meeting. On May 2, Allegro’s President and CEO Vicken Karageozian, MD, provided an overview on the company’s vision moving forward into other ocular indications at the Ophthalmology Innovation Summit. On May 6, Eric D. Donnenfeld, MD, will present full study results of the ALG-1007 proof-of-concept clinical trial for DED at ASCRS/ASOA. Read more.
New World Medical Recognizes Award Recipients
New World Medical, a privately held ophthalmic company dedicated to developing glaucoma devices, announced the recipients of three annual awards. View the recipients.
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