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Volume 16, Number 44
Monday, October 31, 2016
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OCTOBER IS HALLOWEEN SAFETY MONTH



In this issue: (click heading to view article)
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######### Glaucoma Progression in Unaffected Fellow Eyes in Cases Developing Unilateral BRVO
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######### Effect of Leaking Perifoveal Microaneurysms on DME Treated by Combination Therapy
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######### OCTA Detection of Deep Retinal Layer Microvasculature Dropout in Glaucoma
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######### Intravitreal Bevacizumab Injections for DME: Predictors of Response
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  Briefly

 



Glaucoma Progression in Unaffected Fellow Eyes in Cases Developing Unilateral BRVO

Researchers investigated glaucoma progression in eyes with glaucoma that developed unilateral branch retinal vein occlusion in the contralateral eye, as part of a retrospective, case-control study.

They evaluated 40 individuals with glaucoma with unilateral BRVO and baseline mean deviation (MD) of the visual field-matched cases during at least four years of follow-up. They defined glaucoma progression as VF progression, using the modified Anderson criteria of the MD of the VF; performed Kaplan-Meier life table analyses to compare times to confirmed VF progression; and evaluated and related risk factors using the Cox proportional hazards model. The main outcome measure was VF progression.

Comparison of the baseline characteristics between the glaucomatous eyes that developed BRVO and the contralateral glaucomatous eyes that did not develop BRVO showed that BRVO occurred in the more advance-staged eyes. Cases of glaucoma with BRVO in the fellow eyes had significant and frequent detection of disc hemorrhage (35 percent), which was 7.5 percent in cases of glaucoma without BRVO (p=0.003). Four (10 percent) individuals from the glaucoma group without BRVO, and 22 (55 percent) individuals from the glaucoma group with BRVO in the fellow eye showed progression according to the modified Anderson criteria (p<0.001). Disc hemorrhage and the presence of BRVO in the fellow eye were found to be significantly predictive of VF progression using the Cox proportional hazards model.

Researchers concluded that more advanced glaucomatous eyes developed BRVO and that individuals who developed BRVO showed more rapid glaucoma progression in contralateral eyes without BRVO compared with individuals with glaucoma who did not develop BRVO.

SOURCE: Lopilly Park H-Y, Jeon S, Lee MY, et al. Glaucoma progression in the unaffected fellow eye of glaucoma patients who developed unilateral branched retinal vein occlusion. Am J Ophthalmol 2016; Oct 19. [Epub ahead of print].





Effect of Leaking Perifoveal Microaneurysms on DME Treated by Combination Therapy

Investigators evaluated the effect of combination therapy using intravitreal ranibizumab injections and short-pulse focal/grid laser photocoagulation to treat diabetic macular edema, as part of a preliminary single-arm, open-label, prospective clinical study conducted on 21 eyes at four sites in Japan.

The treatment protocol consisted of two phases. The induction IVR phase included two monthly IVRs followed by a pro re nata IVR phase in which additional IVR was administered if the central macular thickness exceeded 300 μm. One week after each IVR in both phases, researchers delivered short-pulse focal/grid laser to treat residual leakage outside of the fovea (>500 μm) and reduce edema fluid influx. At the six-month endpoint, they examined the effects of treatment in terms of best-corrected visual acuity, CMT, and required number of IVR injections in eyes with or without perifoveal leaking microaneurysms (MAs).

In eyes with initial BCVA ≤70 letters, mean BCVA was significantly ameliorated by 7 ±7.4 letters (p=0.0324), and mean CMT improved significantly by 174.8 ±105 µm (p=0.0005). Both BCVA improvement (p=0.8693) and CMT reduction (p=0.9336) were comparable between MA(−) and MA(+) groups. The MA(−) group required significantly fewer p.r.n. injections than did the MA(+) group over the six-month study period (mean: 3.4 ±1.6 vs. 5.3 ±0.9, median: 3 vs. 5.5; p=0.0229).

Investigators determined that short-pulse focal/grid laser photocoagulation could reduce the number of IVR injections required to resolve macular edema and increase BCVA as part of a possible mechanism leading to reduced influx of edema fluid into the foveal area in eyes without apparent perifoveal microaneurysms.

SOURCE: Hirano T, Toriyama Y, Iesato Y, et al. Effect of leaking perifoveal microaneurysms on resolution of diabetic macular edema treated by combination therapy using anti-vascular endothelial growth factor and short pulse focal/grid laser photocoagulation. Jpn J Ophthalmol 2016; Oct 11. [Epub ahead of print].



OCTA Detection of Deep Retinal Layer Microvasculature Dropout in Glaucoma

Scientists investigated factors associated with dropout of the parapapillary deep retinal layer microvasculature assessed by optical coherence tomography angiography in glaucomatous eyes, as part of a cross-sectional study. They assessed 71 eyes from 71 individuals with primary open-angle glaucoma with β-zone parapapillary atrophy (βPPA) enrolled in the Diagnostic Innovations in Glaucoma Study.

Scientists defined parapapillary deep-layer microvasculature dropout as a complete loss of the microvasculature located within the deep retinal layer of the βPPA from OCTA-derived optic nerve head vessel density maps by standardized qualitative assessment. They also calculated circumpapillary vessel density (cpVD) within the retinal nerve fiber layer using OCTA, and determined choroidal thickness and presence of focal lamina cribrosa defects using swept-source OCT.

The main outcome measure was presence of parapapillary deep-layer microvasculature dropout. Scientists analyzed parameters such as age, systolic and diastolic blood pressure, axial length, intraocular pressure, disc hemorrhage, cpVD, visual field mean deviation (MD), focal LC defects βPPA area, and choroidal thickness.

They detected parapapillary deep-layer microvasculature dropout in 37 POAG eyes (52.1 percent). Eyes with microvasculature dropout had a higher prevalence of LC defects (70.3 percent vs. 32.4 percent); lower cpVD (52.7 percent vs. 58.8 percent); worse VF MD (-9.06 dB vs. -3.83 dB); thinner total choroidal thickness (126.5 μm vs. 169.1 μm); longer axial length (24.7 mm vs. 24 mm); larger βPPA (1.2 mm2 vs. 0.76 mm2); and lower diastolic blood pressure (74.7 mmHg vs. 81.7 mmHg) than those without dropout (p<0.05, respectively). In the multivariate logistic regression analysis, factors significantly associated with dropout included higher prevalence of focal LC defects (odds ratio: 6.27; p=0.012), reduced cpVD (OR: 1.27; p=0.002), worse VF MD (OR: 1.27; p=0.001), thinner choroidal thickness (OR: 1.02; p=0.014) and lower diastolic blood pressure (OR: 1.16; p=0.003).

Scientists found that systemic and ocular factors, including focal LC defects, more advanced glaucoma, reduced RNFL vessel density, thinner choroidal thickness and lower diastolic blood pressure were associated with parapapillary deep-layer microvasculature dropout in glaucomatous eyes. They added that longitudinal studies are needed to clarify the temporal relationship between parapapillary deep-layer microvasculature dropout and systemic and ocular factors.

SOURCE: Suh MH, Zangwill LM, Manalastas PI, et al. Deep retinal layer microvasculature dropout detected by the optical coherence tomography angiography in glaucoma. Ophthalmology 2016; Oct 18. [Epub ahead of print].



Intravitreal Bevacizumab Injections for DME: Predictors of Response

Researchers wrote that outcomes of intravitreal anti-vascular endothelial growth factor injections are variable among individuals with diabetic macular edema. They aimed to determine the ocular and systemic predictors of DME response to intravitreal bevacizumab, as part of a retrospective review over two years. An anatomical response to IVB was defined as a 20-percent reduction in central macula thickness after the first course (three injections) of IVB.

In 78 eyes of 54 individuals, 28 percent of cases had an anatomical response after the first course of IVB. Systemic hypertension (odds ratio: 12.1, 95 percent confidence interval 0.7 to 21) was a statistically significant predictor (p=0.025) of a good response to IVB, while previous macular laser was a statistically significant (p=0.0005) predictor of a poor response (odds ratio: 0.07, 95 percent confidence interval 0.01 to 0.32). Sixty-eight percent of eyes underwent subsequent treatment for DME after the first course of IVB. The visual acuity gain at 24 months in hypertensive (0.7 ±3.6 letters) and nonhypertensive (5.2 ±3.7 letters) individuals was not significantly different (p=0.41).

Researchers concluded that hypertension was a positive predictor, and previous macular laser was a negative predictor of response to IVB. However, they found that long-term visual acuity changes weren’t significantly different between eyes with and without systemic hypertension.

SOURCE: Joshi L, Bar A, Tomkins-Netzer O, et al. Intravitreal bevacizumab injections for diabetic macular edema – predictors of response: A retrospective study. Clin Ophthalmol 2016;10:2093-8.

 

 




  • Sun Pharma to Acquire Ocular Technologies
    Sun Pharmaceutical Industries announced its wholly owned subsidiary would acquire 100 percent of Ocular Technologies Sarl (OTS), a portfolio company of Auven Therapeutics. OTS owns exclusive, worldwide rights to Seciera (cyclosporine A, 0.09% ophthalmic solution). Sun Pharma will pay Auven $40 million upfront, contingent development milestones and sales milestones, and tiered royalty on sales of Seciera. Seciera is currently in a Phase III confirmatory clinical trial for the treatment of dry-eye disease. The patented, novel, proprietary formulation of cyclosporine A 0.09% is a clear, preservative-free aqueous solution. In a completed Phase IIb/III clinical trial in 455 individuals, Seciera demonstrated a rapid onset of action and was well-tolerated by the study population. Based on published data, the efficacy and safety endpoints in these trials compared favorably to other formulations of cyclosporine A. Read more.



  • TOPCON Introduces IMAGEnet Connect
    Topcon Corp., announced the release of IMAGEnet Connect, a vendor-neutral ophthalmic workflow, image and data management system that seamlessly connects eye-care devices and systems in clinics for streamlined data management. (IMAGEnet Connect is not available for sale in all countries.) To help achieve its Healthcare through the Eye initiative targeting prognostic management and early detection of disease, Topcon acquired ifa—a European company in the ophthalmological electronic medical record systems space—to obtain the platform to accelerate development of IT solutions that can centrally collect and manage data across the eye-care workflow. This includes screening, examination, diagnosis, treatment and prognosis management. IMAGEnet Connect combines Topcon's established hardware technology and ifa's advanced software technology. Topcon says the system goes beyond traditional picture archiving and communication system functionality, providing efficiency in eye care with: a vendor-neutral archive that is compatible with more than 450 devices; clinician view of all clinical information on a single program; efficient workflow management; intelligent patient flow tracking from check-in to check-out; optimized statistics to improve practice workflow and minimize patient waiting time; integrated test interpretations, clinical remarks, diagnosis and treatment plans; intuitive data input with structured data for diagnosis; compliance with ICD-10, SNOMED and LOINC; and a worldwide sales channels and service network. Read more.



  • Aerie Pharmaceuticals Reports Positive Topline Results, Withdraws FDA NDA
    Aerie Pharmaceuticals reported 90-day topline efficacy results from its Rocket 4 Phase III clinical trial of product candidate Rhopressa, a novel, once-daily eye drop being tested for its ability to lower intraocular pressure in individuals with glaucoma or ocular hypertension. The trial is designed to provide adequate six-month safety data for European regulatory filing purposes, although the trial is not necessary for NDA filing purposes. Rocket 4, which enrolled a total of approximately 700 individuals, is a two-arm, six-month trial, which includes a 90-day efficacy readout evaluating once-daily Rhopressa for non-inferiority to twice-daily timolol. The range for the primary endpoint includes individuals with baseline IOPs from above 20 mmHg to below 25 mmHg. The study achieved its primary efficacy endpoint demonstrating non-inferiority of once-daily Rhopressa compared to twice-daily timolol. Separately, Aerie announced that it withdrew the Rhopressa new drug application submitted to the FDA in the third quarter of 2016 as a result of a third-party manufacturing facility in Tampa, Fla., not being ready for pre-approval inspection by the FDA. The drug product contract manufacturer advised Aerie and the FDA that it expects to be prepared for inspection in January 2017, and Aerie expects to resubmit the Rhopressa NDA filing at that time. Read more.



  • Second Sight Implants Wireless Visual Cortical Stimulator in First Human Subject
    Second Sight Medical Products announced the first successful implantation and activation of a wireless visual cortical stimulator in a human subject, providing the initial human proof of concept for ongoing development of the company’s Orion I Visual Cortical Prosthesis. In a UCLA study supported by Second Sight, a 30-year-old individual implanted with a wireless, multichannel neurostimulation system on the visual cortex was able to perceive and localize individual phosphenes, or spots of light, with no significant adverse side effects. This implant was performed as part of a proof-of-concept clinical trial with a goal of demonstrating initial safety and feasibility of human visual cortex stimulation. The initial success of the study and pre-clinical work will prepare Second Sight to submit an application to the FDA in early 2017 to gain approval for an initial clinical trial of the complete Orion I system, including camera and glasses. Read more.



  • Sixty Percent of Americans with Diabetes Skip Annual Eye Exams
    People with diabetes are at increased risk of developing serious eye diseases, yet most do not have annual eye exams, according to a large study presented at the American Academy of Ophthalmology annual meeting in Chicago. Researchers at Wills Eye Hospital found that more than half of individuals with the disease skip these exams. They also discovered that patients who smoke, and those with less severe diabetes and no eye problems were most likely to neglect the exams. Researchers collaborated with the Centers for Disease Control and Prevention to review the charts of nearly 2,000 individuals ages 40 or older with type 1 and type 2 diabetes. Read more.



  • PanOptica Reports Positive Results from Phase I/II Clinical Trial
    PanOptica reported positive data from a Phase I/II study of PAN-90806, a topical anti-vascular endothelial growth factor eye drop in development for the treatment of neovascular eye diseases. Based on these results, the company plans to initiate a Phase I/II clinical trial in 2017 of a next-generation formulation of topical PAN-90806 in individuals with neovascular age-related macular degeneration. Scott W. Cousins, MD, Robert Machemer professor of ophthalmology and immunology, vice chair for research, and director of the Duke Center for Macular Diseases, presented data on behalf of investigators from the Phase I/II study in 50 treatment-naïve individuals with wet AMD that received topical PAN-90806, during the 2016 Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting in Chicago. An independent panel of retina experts including Dr. Cousins confirmed positive biological response to topical PAN-90806 in approximately 45 percent to 50 percent of treated individuals. Read more.



  • Trailblazers in Eye Care Honored at AAO 2016
    Influential leaders in eye care were honored at the American Academy of Ophthalmology's Academy's annual meeting in Chicago. The prestigious Laureate Recognition Award, which recognizes ophthalmologists who make exceptional scientific contributions to preventing blindness and restoring sight worldwide, went to Matthew D. Davis, MD, for his groundbreaking work in the study of retinal diseases. Dr. Davis chaired the first clinical trials in the 1970s that showed effectiveness of scatter laser photocoagulation and vitrectomy surgery for diabetic retinopathy. These trials created standard-of-care treatments still being used and models of clinical research for treating the disease. Dr. Davis also established the center that developed photographic standards and systems for analyzing photographs of the retina and assessing changes over time. He was also involved in the development of classifications for diabetic retinopathy and scales for age-related macular degeneration. Read more.



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