From the editors of Review of Ophthalmology:
DECEMBER IS SAFE TOYS AND CELEBRATIONS MONTH
In this issue: (click heading to view article)
Durability of DR Improvement with PRN Ranibizumab
Researchers evaluated durability of diabetic retinopathy improvements after a change in ranibizumab dosing from monthly to customized pro re nata therapy. They employed a pooled analysis of the open-label extension of RIDE/RISE study subjects with DR and diabetic macular edema.
In the RIDE/RISE studies, subjects (n=759) were randomized 1:1:1 to ranibizumab 0.3 mg monthly, 0.5 mg monthly or monthly sham injections with rescue macular laser available after six months. After 24 months, sham subjects crossed over to ranibizumab 0.5 mg monthly. After 36 months in the core studies, subjects in the OLE (n=500) could receive ranibizumab 0.5 mg through an individualized PRN dosing regimen based on predefined DME retreatment criteria. DR severity was evaluated photographically using the Early Treatment Diabetic Retinopathy Study DR severity scale. The main outcome measure included the change in DR severity from months 36 to 48 by retreatment status.
• Among subjects who entered the OLE, 121/500 (24 percent) didn’t require additional ranibizumab injections.
• In total, 442 subjects had evaluable DR outcomes during the OLE; 367 had evaluable DR at months 36 and 48.
• Among subjects not requiring ranibizumab retreatment from months 36 to 48 (88/367): 57 to 78 percent experienced DR severity stability, 0 to 7 percent experienced ≥2-step improvements, and 22 to 36 percent experienced ≥2-step worsening.
• Among subjects requiring ranibizumab retreatment (279/367): 84 to 94 percent experienced DR severity stability, 2 percent experienced ≥2-step improvements, and 3 to 14 percent experienced ≥2-step worsening.
• On average, vision improvements were maintained during the OLE regardless of change in DR severity.
DR severity improvements with ranibizumab were maintained in the majority of subjects in the OLE after switching from ranibizumab monthly to an individualized ranibizumab 0.5 mg PRN dosing regimen (using best-corrected visual acuity and optical coherence tomography to evaluate). Researchers wrote that, because nearly one-third of OLE subjects not requiring further therapy for DME experienced DR worsening, they recommended that individuals be watched carefully once DME resolves for DR worsening and need for more frequent follow-up or treatment with anti-VEGF or other modalities.
SOURCE: Sun JK, Wang PW, Taylor S, et al. Durability of diabetic retinopathy improvement with as-needed ranibizumab: Open-label extension of RIDE and RISE studies. Ophthalmology 2018; Nov 9. [Epub ahead of print].
Clinical Ultrahigh-resolution SD-OCT Using A-Scan Matching Algorithm
Researchers developed a new clinical ultrahigh-resolution spectral-domain optical coherence tomography system using an original averaging algorithm they call A-scan matching. The aim of this study was to determine whether the system could obtain clearer sectional images of the retina than conventional standard-resolution SD-OCT systems. Two of the authors received honoraria and/or financial support from the maker of the A-scan matching OCT device, Kowa.
Investigators recorded horizontal B-scan images of 42 normal eyes using the UHR-SD-OCT device (Bi-μ, Kowa) and a conventional SR-SD-OCT (Spectralis, Heidelberg). To evaluate the clarity of the interdigitation zone subjectively, raters divided the integrity of IZ into three types by two raters. To evaluate the clarity of the IZ objectively, they calculated a peak height score at five different points of the macula using the longitudinal reflectivity profile.
The mean (±SD) of the subjective visibility score of the IZ in the UHR-SD-OCT images was 2.64 ±0.54, which was significantly higher than the 2.46 ±0.46 in the SR-SD-OCT images (p=0.02). The peak height score was also significantly higher for the UHR-SD-OCT than for the SR-SD-OCT images at all five locations (all p<0.01).
Investigators wrote that results indicated that the newly developed clinical UHR-SD-OCT instrument using the A-scan matching algorithm could obtain clearer images of the IZ, suggesting the device should be clinically useful in detecting finer structural abnormalities of the outer retina.
Source: Matsui Y, Kondo M, Uchiyama E, et al. New clinical ultrahigh-resolution SD-OCT using A-scan matching algorithm. Graefes Arch Clin Exp Ophthalmol 2018; Nov. 7. [Epub ahead of print].
Evaluation of Aqueous Endocan & Endostatin Levels in PEX Syndrome
Scientists evaluated the aqueous humor endocan and endostatin levels in individuals with pseudoexfoliation syndrome and compared the results with healthy individuals.
A total of 29 cataract subjects with PEX syndrome and 32 cataract subjects without PEX syndrome (control group) were enrolled. Scientists measured endocan and endostatin levels in the aqueous humor of the PEX and control groups by enzyme-linked immunosorbent assay.
• There was no difference between the PEX and control groups in terms of age (p=0.721) and sex (p=0.902).
• The aqueous levels of endocan in PEX subjects (26.39 ±5.80 pg/mL) were significantly higher than in the control group (11.42 ±2.44 pg/mL) (p=0.039).
• The aqueous levels of endostatin were 12 ±1.35 ng/mL in the PEX group and 14.22 ±3.31 ng/mL in the control group; however, the difference wasn’t statistically significant (p=0.41).
Scientists concluded that the findings indicated that increased levels of aqueous endocan might be related to the pathogenesis of PEX. However, they added, levels of aqueous endostatin didn’t show any significant difference in PEX.
SOURCE: Yağcı R, Dervişoğulları S, Güler E, et al. Evaluation of aqueous endocan and endostatin levels in patients with pseudoexfoliation syndrome.J Glaucoma 2018; Oct 18. [Epub ahead of print].
Microbiological Evaluation of Bandage Soft CLs in Managing Persistent Corneal Epithelial Defects
Researchers analyzed the rate and agents of contamination in bandage soft contact lenses fitted for management of persistent corneal epithelial defects, as part of a prospective, comparative case series enrolling 57 consecutive eyes.
The lenses were collected at the time of epithelial closure or when it was necessary to exchange CLs and were immediately placed in sterile tubes containing an enriched thioglycolate liquid medium. When researchers detected contamination of the CLs, they cultured the microorganisms in different media and identified them based on various tests. They tested all isolates for susceptibility to various antibiotics and used univariate analyses to evaluate the influence of different variables (duration of CL use, use of topical corticosteroids, presence of blepharitis, CL deposits and presence of sutures) on bandage CL contamination.
• Seventeen CLs (29.8 percent) were contaminated.
• The most commonly isolated pathogens were in descending order: Staphylococcus epidermidis (n=10), Enterobacter cloacae (n=3), Staphylococcus aureus (n=1), Streptococcus viridans (n=1) and Alcaligenes spp. (n=1).
• One CL yielded a mixed infection with E. cloacae and Candida spp.
• Infectious keratitis wasn’t observed in any eyes.
• Correlations between contact lens contamination and subject- and lens-related variables weren’t statistically significant.
Researchers determined that most bandage CLs (70.2 percent) used for treatment of persistent corneal epithelial defects didn’t show bacterial growth. They found that S. epidermidis was the most common microorganism isolated from the contaminated CLs.
SOURCE: Feizi S, Masoudi A, Hosseini SB, et al. Microbiological evaluation of bandage soft contact lenses used in management of persistent corneal epithelial defects. Cornea 2018; Nov. 12. [Epub ahead of print].
Verily & Alcon Table THEIR Work on Glucose-sensing CL
Verily and Novartis’ Alcon unit decided to put work on a smart contact lens to measure glucose levels in users with diabetes on hold, according to a blog post by Verily’s chief technical officer, Brian Otis, PhD. Dr. Otis said that the group’s clinical work on the glucose-sensing lens demonstrated that there was insufficient consistency in measurements of the correlation between tear glucose and blood glucose concentrations to support the requirements of a medical device. He added, however, that Verily was looking forward to the next phase of development on other two Smart Lens programs with Alcon, in which technical learnings and achievements would be applied to prevalent ophthalmic conditions. Read more.
FDA Approves ACTPen for Genentech’s Actemra
Genentech announced that the FDA approved ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra (tocilizumab) as an additional formulation for adult patients with giant cell arteritis and adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. Read more.
Alcon Launches Alcon Retina Fellows Institute
Alcon is launching the Alcon Retina Fellows Institute, an educational offering supporting retina fellows during a weekend-long training at the Alcon Experience Center in Fort Worth, Texas. The program, led by a group of world-class faculty, features the latest innovations in retina surgery, and offers hands-on trainings for key procedures in a surgical laboratory setting. The Institute will be an annual event in which attendees will have the opportunity to visit the Alcon Experience Center in Fort Worth, which Alcon describes as a state-of-the-art facility providing eye care professionals with comprehensive eye health education, experiential learning opportunities and virtual reality technology for an immersive training experience. Learn more.
Reimbursement for Dexycu
EyePoint Pharmaceuticals announced that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code through the Healthcare Common Procedure Coding System for the company’s drug Dexycu (dexamethasone intraocular suspension) 9%. Dexycu is a single dose, sustained-release, intracameral steroid indicated for the treatment of postoperative inflammation.
The company expects to launch the drug in the first half of 2019. The code, J1095, will become effective on January 1, 2019, and will replace the previously issued C-code for Dexycu (C9034) that became effective on October 1, 2018. The Company still retains transitional pass-through status for Dexycu from CMS for approximately three years. Read more.
Santen Expands R&D Leadership Team
Santen recently expanded its research and development leadership team. Reza M. Haque, MD, PhD, was appointed as senior vice president, global research and development strategy, and Peter Sallstig, MD, MBA, was appointed as senior vice president, global product development. Dr. Haque will lead global research and development strategy for all areas of ophthalmology, including glaucoma, retina, and cornea and external diseases, while Dr. Sallstig will be responsible for the strategy, design, and execution of clinical ophthalmology programs through all phases of development, regulatory submissions and post-marketing. Read more.
ERI & Bosma Enterprises Announce Postdoctoral Research Fellowship
The Gigi & Carl Allen Envision Research Institute is calling for letters of intent for its next round of postdoctoral research fellowships. Fellowships last for a minimum of one year and maximum of two, pending a review of the first year’s progress and results, and are primarily carried out on-site at ERI. The ERI, launched in 2015 with a goal to restore function to those who are blind and visually impaired, and provide access to funds, facilities, mentors and prospective study subjects for postdoctoral research. Learn more.
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