From the editors of Review of Ophthalmology and Retina Specialist
THE LATEST PUBLISHED RESEARCH
WELCOME to Review of Ophthalmology's Retina Online newsletter. Each month, Medical Editor Philip Rosenfeld, MD, PhD, and our editors provide you with this timely and easily accessible report to keep you up to date on important information affecting the care of patients with vitreoretinal disease.
Macular Atrophy in nAMD: Ranibizumab vs. Aflibercept (The RIVAL Study)
In the Novartis-sponsored RIVAL study, researchers evaluated differences in development of macular atrophy and other efficacy outcomes over 24 months between treat-and-extend (T&E) ranibizumab and aflibercept in individuals with neovascular age-related macular degeneration.
As part of the Phase IV, randomized, partially masked, multicenter study, individuals ages ≥50 years diagnosed with active, treatment-naive subfoveal choroidal neovascularization secondary to nAMD with baseline best-corrected visual acuity of ≥23 logMAR letters were included.
Patients were randomized 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2 mg, and treated according to the same reading center-guided T&E regimen following three initial monthly injections. The primary outcome was mean change in square root area of MA from baseline to month 24. Key secondary outcomes included number of injections and mean change in BCVA from baseline to months 12 and 24.
A total of 278 individuals were included in the analysis (ranibizumab 0.5 mg, n=141; aflibercept 2.0 mg, n=137). Here were some of the findings:
• Mean change in square root area of MA from baseline to month 24 was +0.36 mm for ranibizumab and +0.28 mm for aflibercept; treatment difference: +0.08 mm (p=0.24).
• The proportion of individuals with MA increased from 7 percent (10/141) to 37 percent (43/117) for ranibizumab and from 6 percent (8/137) to 32 percent (35/108) for aflibercept from baseline to month 24.
• The average number of injections received per year was similar between both groups: 9.6 for ranibizumab and 9.5 for aflibercept.
• The mean change in BCVA from baseline to month 24 was +6.6 letters for the ranibizumab group and +4.6 letters for the aflibercept group; treatment difference: 2 letters (p=0.15).
• Rates of adverse events (AEs) were similar between both groups.
Researchers observed no significant differences in the rate of growth and development of MA over 24 months between ranibizumab and aflibercept in nAMD treated using an identical T&E regimen. They found that ranibizumab and aflibercept resulted in similar visual acuity improvements over 24 months with similar number of injections and AEs.
Source: Gillies MC, Hunyor AP, Arnold JJ, et al. Macular atrophy in neovascular age-related macular degeneration: A randomized clinical trial comparing ranibizumab and aflibercept (the RIVAL study). Ophthalmology 2019; Aug 27. [Epub ahead of print].
Choriocapillaris Impairment in Eyes with CNV Secondary to AMD
Researchers developed an optical coherence tomography angiography-based framework for quantitatively analyzing the spatial distribution of choriocapillaris (CC) impairment around choroidal neovascularization secondary to age-related macular degeneration.
In a retrospective, cross-sectional study, they quantitatively analyzed 400-kHz swept-source OCTA images from seven eyes of six individuals with CNV secondary to AMD using custom software. Researchers developed a lesion-centered zonal OCTA analysis technique, which portioned the field-of-view into zones relative to CNV boundaries, to quantify the spatial dependence of CC flow deficits.
Quantitative, lesion-centered zonal analysis of CC OCTA images revealed the highest flow-deficit percentages near CNV boundaries, decreasing in zones farther from the boundaries. OCTA using shorter interscan times (1.5 ms) revealed more severe flow deficits than OCTA using longer interscan times (3 ms); however, spatial trends were similar for both interscan times. Researchers provided a detailed description of the OCTA processing steps and parameters to elucidate their influence on quantitative measurements.
Researchers determined that CC impairment, assessed by flow-deficit percentages, was most prominent near CNV boundaries. The lesion-centered zonal analysis technique enabled quantitative CC measurements relative to focal lesions. Researchers wrote that understanding how processing steps, imaging/processing parameters and artifacts can affect quantitative CC measurements is important for longitudinal, OCTA-based studies of disease progression and treatment response.
SOURCE: Moult EM, Alibhai AY, Rebhun C, et al. Spatial distribution of choriocapillaris impairment in eyes with choroidal neovascularization secondary to age-related macular degeneration: A quantitative OCT angiography study. Retina 2019; Aug 13. [Epub ahead of print].
Using OCTA to Identify Impact of Slab Selection on Quantification of Choriocapillaris Flow Deficits
Investigators assessed the impact of slab selection on quantitative measurements of choriocapillaris (CC) flow deficits using swept-source optical coherence tomography angiography, as part of a cross-sectional study.
They first generated en face slabs to isolate the CC using the manufacturer’s default setting: a 20 μm-thick slab starting 29 μm posterior to the centerline of the automatically segmented retinal pigment epithelium band. They then adjusted the inner and outer borders by 2-μm increments to generate CC slabs with a range of offsets relative to the center of the RPE band. They compared flow deficits between the modified slabs to those of the default slab.
Twenty-seven eyes of healthy subjects (mean age: 42 years) were prospectively enrolled. Here were some of the findings:
• Flow deficit percent increased when the slab was shifted outward by ≥4μm and inward by 20 μm (p<0.05).
• Fifteen eyes (55.6 percent) showed large hypointense regions precluding quantification when the slab was shifted inward by 20 μm.
• Those without hypointensity demonstrated a decrease in flow deficit percent when the slab was shifted inward by 10 to 18 μm (p<0.05).
• When modulating slab thickness, CC flow deficit percent increased when the slab thickness became thinner by ≥8 μm and decreased when the slab thickness became thicker by ≥8 μm (p<0.05).
Investigators determined that quantitative CC parameters might be significantly influenced by small differences in the slab selection. They found that slabs close to the RPE could be susceptible to segmentation errors. Investigators wrote that the findings highlighted the importance of an accurate, precise and consistent slab definition to reliably generate quantitative CC metrics from OCTA.
SOURCE: Byon I, Nassisi M, Borrelli E, et al. Impact of slab selection on quantification of choriocapillaris flow deficits by optical coherence tomography angiography. Am J Ophthalmol 2019; Sep 4. [Epub ahead of print].
Using Projection-resolved OCTA to Assess Reduced Retinal Vessel Density in GA Secondary to AMD
Scientists compared retinal vessel density in eyes with geographic atrophy secondary to age-related macular degeneration to age-matched healthy eyes using projection-resolved optical coherence tomography angiography (PR-OCTA), as part of a prospective, cross-sectional study.
Study participants underwent macular 3-mm2 OCTA scans with spectral-domain OCTA. Reflectance-compensated retinal vessel densities were calculated on projection-resolved superficial vascular complex (SVC), intermediate capillary plexus (ICP) and deep capillary plexus (DCP). Quantitative analysis using normalized deviation compared the retinal vessel density in GA regions, 500 μm GA rim regions and non-GA regions to similar macular locations in control eyes.
Ten eyes with GA and 10 control eyes were studied. Here were some of the findings:
• Eyes with GA had significantly lower vessel density in the SVC (54.8 ±2.4 percent vs. 60.8 ±3.1 percent, p<0.001); ICP (34 ±1.5 percent vs. 37.3 ±1.7 percent, p=0.003); and DCP (24.4 ±2.3 percent vs. 28 ±2.3 percent, p<0.001) compared with control eyes.
• Retinal vessel density within the GA region decreased significantly in SVC, ICP and DCP.
• Retinal vessel density in the GA rim region decreased in the SVC and ICP, but not in the DCP.
• The non-GA region didn’t significantly deviate from normal controls.
• Eyes with GA had significantly reduced photoreceptor layer thickness, but similar ganglion cell complex thickness; and similar nerve fiber, inner nuclear and outer plexiform thickness.
Scientists wrote that GA eyes had reduced retinal vessel density in SVC, ICP and DCP compared with controls. They added that loss was greatest within GA regions. Furthermore, they wrote, vessel density might be more sensitive than retinal layer thickness measurements in detecting inner retinal changes in eyes with GA.
SOURCE: You QS, Wang J Yukun Guo Y, et al. Detection of reduced retinal vessel density in eyes with geographic atrophy secondary to age-related macular degeneration using projection-resolved optical coherence tomography angiography. Am J Ophthalmol 2019; Sep 14. [Epub ahead of print].
Quantitative Ultra-widefield Angiographic Features & Associations with DME
Investigators examined the relationship between diabetic macular edema and quantitative ultra-widefield fluorescein angiography (UWFA) metrics of ischemia, leakage and microaneurysms (MAs), as part of a retrospective image analysis study
Eyes with diabetic retinopathy that had undergone spectral-domain optical coherence tomography, UWFA and ultra-widefield fundus photography were included. Investigators analyzed OCT images to determine the presence or absence of DME, central subfield thickness (CST) and subretinal fluid (SRF). Using a semi-automated analysis platform, they segmented UWFA images for ischemia, leakage and MAs with manual correction as needed. Clinical variables including age, sex, race, hemoglobin A1C, blood pressure, cholesterol levels, use of blood thinners, smoking status and lens status were also evaluated.
Main outcome measures included factors associated with the presence and severity of DME. A total of 304 eyes (156 OD, 148 OS) from 178 diabetic patients were analyzed in the study. Here were some of the findings:
• Panretinal leakage index, MA count and ischemic index weren’t significantly different between eyes with and without DME in univariate assessment.
• Zonal assessments of macular MAs and macular leakage index values revealed that eyes with DME had a significantly higher MA count (p=0.001) and leakage index (p<0.0001) in the posterior pole compared with eyes without DME.
• Severity of macular thickening (i.e., CST) was significantly associated with macular leakage index (p=0.0002) and posterior pole MA count (p=0.03).
• In addition to posterior pole leakage index and MA count, DME was associated with older age (p<0.01), higher systolic blood pressure (p<0.001) and Caucasian race (p=0.03).
• Multivariate assessment confirmed independent association of presence of DME with macular leakage index and macular MA count (p<0.01).
Investigators determined that quantitative measures of leakage index and MA count in the posterior pole on UWFA images were associated with the presence and severity of DME. However, they found that panretinal analyses weren’t as strongly linked to DME. The researchers concluded that additional research would be needed to determine the role of quantitative UWFA in predicting DME development and characterizing the prognosis.
SOURCE: Jiang AC, Srivastava SK, Hu M, et al. Quantitative Ultra-widefield angiographic features and associations with diabetic macular edema. Ophthalmology Retina 2019; Aug. 28. [Epub ahead of print].
Repeated Panretinal Photocoagulation in RIDE and RISE
Researchers evaluated panretinal photocoagulation treatment and retreatment patterns in patients with diabetic retinopathy and diabetic macular edema, as part of a post hoc analysis of the Phase III RIDE and RISE clinical trials of ranibizumab for the treatment of DME.
A total of 759 patients who were randomized for treatment took part in the study in which researchers assessed PRP treatment patterns and clinical experiences by baseline PRP treatment status. Main outcome measures included number and timing of on-study PRP treatment sessions received through month 24. Researchers also assessed time to any new proliferative events (composite endpoint). Here were some of the findings:
• At baseline, ∼25 percent of patients in RIDE and RISE had received PRP treatment before enrollment (22.2 percent, 24.4 percent, and 25.4 percent of patients in the sham, ranibizumab 0.3 mg, and ranibizumab 0.5 mg arms, respectively).
• In patients without prior PRP at baseline (n=577), 9.5 percent of sham-treated individuals received ≥1 PRP treatment through month 24 compared with 1.1 percent and 1.6 percent of patients treated with ranibizumab 0.3 mg and ranibizumab 0.5 mg, respectively (p<0.001 for both ranibizumab arms vs. sham).
• In patients with prior PRP at baseline (n=182), 19.3 percent of sham-treated patients received ≥1 PRP treatment through month 24.
• No ranibizumab-treated patients with prior PRP at baseline required additional on-study PRP through month 24 (p<0.001 for both ranibizumab arms vs. sham).
• Ranibizumab treatment also significantly reduced clinical DR progression among individuals who received prior PRP.
• By month 24 in individuals with prior PRP at baseline, the probability of experiencing a new proliferative event was 10.3 percent and 9.9 percent in patients treated with ranibizumab 0.3 mg and ranibizumab 0.5 mg, respectively, compared with 39.4 percent in sham-treated patients (p<0.0001).
• Overall, sham-treated patients, including those patients who were PRP-naïve at baseline who went on to require PRP, experienced more clinical events than ranibizumab-treated patients.
Researchers wrote that, in RIDE and RISE, PRP treatment was not a “one-and-done” procedure, with on-study PRP retreatment occurring in individuals both with and without prior PRP treatment at baseline. Ranibizumab treatment reduced on-study PRP treatment and DR progression regardless of prior PRP treatment status at baseline.
Source: Gonzalez VH, Wang P-W, Quezada Ruiz C, et al. Panretinal photocoagulation for diabetic retinopathy in the RIDE and RISE trials: Not “one and done.” Ophthalmology 2019; Aug 21. [Epub ahead of print].
Evaluating PDR with OCT
Researchers presented the routine use of optical coherence tomography and OCT angiography for the objective diagnosis and monitoring of proliferative diabetic retinopathy, as part of a retrospective, observational case series.
Individuals with diabetic retinopathy routinely imaged with a standardized PDR-protocol between March 2017 and January 2019, were included. This included a 12 x 9-mm structural OCT volume centered on the macula and a 6 x 6-mm OCTA scan centered on the optic nerve head, obtained using a Topcon swept-source system (DRI OCT-1 Triton). Ultra-widefield fluorescein angiography was also performed when clinically indicated. The ground truth for each case was determined by merging the findings from biomicroscopy and imaging modalities to generate the maximum level of detection for each finding.
Main outcome measures included detection rates of new-onset, regression and reactivation of neovascularization of the disc, and neovascularization elsewhere (NVE) using different modalities (biomicroscopy/color photography, structural OCT, B-scan OCTA and en face OCTA). Detection of progression of tractional retinal detachment (TRD) was another outcome measure.
A total of 383 eyes of 204 patients were evaluated. After excluding patients without PDR or with insufficient image quality, 47 eyes of 35 patients were included. Here were some of the findings:
• For the detection of new-onset NVD and NVE, structural OCT had the highest detection rate (100 percent) of all modalities.
• For the detection of regression or reactivation of neovascularization, B-scan OCTA had the highest detection rate (100 percent), as structural OCT detected regression in only 45.5 percent of cases, resulting in a low detection rate of reactivation (12.5 percent).
• Among 10 eyes with TRD, OCT detected fovea-threatening TRD during follow-up in seven eyes, resulting in vitrectomy.
Researchers wrote that the study demonstrated the utility of novel multimodal imaging in the daily management of individuals with PDR. They added that posterior pole structural OCT had the best detection rate for neovascularization, while B-scan OCTA showed the most potential for objective monitoring of disease following treatment.
SOURCE: Schwartz R, Khalid H, Sivaprasad S, et al. Objective evaluation of proliferative diabetic retinopathy using optical coherence tomography. Ophthalmology Retina 2019; Sept. 11. [Epub ahead of print].
Ranibizumab in Asian Patients with BRVO: BLOSSOM Study
Scientists evaluated the efficacy and safety profile of intravitreal ranibizumab 0.5 mg in Asian patients with visual impairment due to macular edema secondary to branch retinal vein occlusion, as part of a 12-month, Phase III, double-masked study sponsored by Novartis.
A total of 283 individuals with BRVO participated. Individuals ages ≥18 years were randomized (2:1) to receive either ranibizumab 0.5 mg or sham. The ranibizumab group received a minimum of three monthly intravitreal injections until stable maximal visual acuity was achieved. This was followed by an individualized, VA stabilization, criteria-driven, pro re nata regimen. Patients in the sham group received sham injections up to month five and could receive ranibizumab 0.5 mg PRN from month six.
Main outcome measures included the mean average change in best-corrected VA from baseline to month one through month six, and safety up to month 12. Here were some of the findings:
• At baseline, patients’ mean BCVA was 57.4 ±11.7 letters and mean central subfield thickness (CSFT) was 525 ±193.4 μm.
• Compared with sham, ranibizumab treatment resulted in superior VA gains.
• The least squares (LS) mean average change in BCVA from baseline to month one to month six was +12.5 letters in the ranibizumab group and +5 letters in the sham group (LS mean difference between ranibizumab vs. sham: +7.5 letters [CI, 5.5 to 9.5], one-sided p<0.001).
• The LS mean change from baseline at month 12 in the ranibizumab vs. sham group in BCVA was +16.4 vs. +11.4 letters; and in CSFT was -280 vs. -269.7 μm, respectively.
• The mean number of injections over 12 months was 7 (±2.55 in the ranibizumab group and 3.6 ±1.60 in the sham with ranibizumab group).
• No new safety findings were reported.
Scientists found that individualized PRN ranibizumab treatment was statistically superior to sham at month six and led to early visual gains that were maintained up to 12 months. They added that results from the sham group indicated the importance of early treatment in achieving optimal visual outcomes in BRVO. Furthermore, the scientists wrote, the safety of ranibizumab in the study was consistent with the drug’s well-established safety profile.
SOURCE: Wenbin W, Weisberger A, Zhu L, et al. Efficacy and safety of ranibizumab in Asian patients with branch retinal vein occlusion: Results from the Randomized BLOSSOM study. Ophthalmology Retina 2019; Aug. 13. [Epub ahead of print].
Automated Macular Segmentation with SD-OCT in Fellow Eyes with Unilateral RVO
Researchers assessed changes in the macular layers in the fellow eyes of unilateral retinal vein occlusion patients and evaluated whether certain layers were more impacted, based on RVO type.
The retrospective study included 87 fellow eyes of individuals with unilateral RVO (26 central, 61 branch) and 105 eyes of 105 subjects without RVO. Researchers used spectral-domain optical coherence tomography for automated retinal segmentation. They documented thicknesses of ganglion cells, retinal pigment epithelium; and retinal nerve fiber, inner plexiform, inner nuclear, outer plexiform, outer nuclear, photoreceptor and overall inner retinal layers. Here were some of the findings:
• The inner plexiform layer was thinner in the inferior sector in the RVO group compared with the control group (p=0.047).
• The subgroup analysis showed that the retina was thinner in the RVO group compared with controls without systemic diseases in some sectors of the following layers: inferior retinal; RNFL; ganglion cell; inner plexiform; inner retinal and RPE (p<0.05).
• Retinal thickness was decreased in the fellow eyes of the branch RVO group compared with the thickness in the fellow eyes of the central RVO group in same sectors (p<0.05).
Researchers found that the fellow eyes of unilateral RVO patients didn’t show major structural differences compared with controls; however, they revealed significant sectoral thinning in many retinal layers when compared with the eyes of healthy subjects without systemic diseases. They also determined that the central maculas were thinner in fellow eyes with branch RVO compared with those in fellow eyes with central RVO.
Source: Cetin EN, Bozkurt K, Parca O, et al. Automated macular segmentation with spectral domain optical coherence tomography in the fellow eyes of patients with unilateral retinal vein occlusion. Int Ophthalmol 2019;39:9:2049-56.
SD-OCT Predictors of Visual Outcomes after Ranibizumab for ME due to RVO
Researchers evaluated spectral-domain optical coherence tomography features associated with baseline vision and visual outcomes after seven monthly ranibizumab doses in the prospective, multicenter Study Evaluating Dosing Regimens for Treatment with Intravitreal Ranibizumab Injections in Subjects with macular Edema following Retinal Vein Occlusion (SHORE). Two of the study authors are employees of Genentech, maker of ranibizumab.
As part of the post-hoc analysis of prospective clinical trial data, researchers studied 202 participants in the 15-month, Phase IV study comparing monthly versus pro re nata ranibizumab after seven monthly doses in eyes with retinal vein occlusions with macular edema.
Researchers assessed the baseline SD-OCT images for: 1) central subfield thickness; 2) presence of vitreomacular adhesion, vitreomacular traction or epiretinal membrane; 3) presence, location and amount of intraretinal or subretinal fluid (IRF or SRF); 4) presence, location and amount of hyperreflective foci (HF); 5) disorganization of retinal inner layers (DRIL); and 6) disruption of external limiting membrane (ELM); ellipsoid zone (EZ); and interdigitation zone (IZ). Researchers performed univariate and multivariable regression analyses to evaluate the association of these features with baseline BCVA and change in BCVA after seven initial monthly ranibizumab injections.
The main outcome measure included the association of SD-OCT features with baseline BCVA and change in BCVA after seven monthly ranibizumab injections. Here were some of the findings:
• Prior to therapy, worse baseline BCVA was associated with ERM presence (p=0.0045), thicker SRF (p=0.0006), larger size of intraretinal cysts (p=0.0015) as well as higher percentage of DRIL (p<0.0001), percentage of ELM disruption (p<0.0001), percentage of EZ disruption (p=0.0003) and percentage of IZ disruption (p=0.0018).
• In multivariate models, only the percentage of ELM disruption independently impacted baseline BCVA (p<0.0001). After seven monthly ranibizumab injections, mean BCVA improved by 18.3 ±12.6 ETDRS letters in treated eyes.
• The only factors independently associated with BCVA gain after seven monthly ranibizumab treatments were younger age (p<0.0001) and worse baseline BCVA (p<0.0001).
Researchers determined that, while SD-OCT features might be associated with presenting vision in eyes with macular edema due to RVO, most eyes treated with ranibizumab experience substantial vision gains, and only older age and better baseline BCVA limited visual improvements.
SOURCE: Yiu G, Welch J, Wang Y, et al. SD-OCT Predictors of visual outcomes after ranibizumab treatment for macular edema due to retinal vein occlusion. Ophthalmology Retina 2019; Aug. 28. [Epub ahead of print].
ALLEGRO PRESENTS PHASE II RISUTEGANIB INTERMEDIATE DRY AMD STUDY AT EURETINA CONGRESS & THE RETINA SOCIETY ANNUAL MEETING
Allegro Ophthalmics announced that results of its U.S. Phase II study evaluating risuteganib (Luminate) for the treatment of intermediate nonexudative age-related macular degeneration were presented during the 19th European Society of Retina Specialists (EURETINA) Congress in Paris, and at The Retina Society 2019 Annual Meeting in London. In June, Allegro announced topline results of the risuteganib Phase II intermediate dry AMD clinical trial, which met its primary endpoint with 48 percent of patients in the risuteganib arm at week 28 gaining ≥8 letters in visual acuity from baseline, compared with 7 percent of patients in the sham group at week 12 (p=0.013). Risuteganib was found to be safe with no reported drug-related serious adverse events. Read more.
Source: Allegro Ophthalmics, LLC, September 2019
FDA Accepts Biologics License Application for Abicipar pegol
Allergan and Molecular Partners announced that the FDA accepted a Biologics License Application for abicipar pegol, a novel, investigational DARPin therapy, in patients with neovascular age-related macular degeneration. The FDA is expected to take action on the BLA mid-2020. The filing is based on data from two Phase III trials, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. six) dosed monthly in the first year. Read more.
SOURCE: Allergan, Molecular Partners AG, September 2019
OXURION COMPLETES Enrollment OF PHASE I CLINICAL TRIAL EVALUATING THR-687
Oxurion NV announced the completion of enrollment of patients in a Phase I trial with THR-687. The open-label, multicenter, dose escalation study is evaluating the safety of a single intravitreal injection of escalating dose levels (three) of THR-687 for the treatment of patients with diabetic macula edema. A total of 12 patients with DME have been enrolled in the U.S.-based study. THR-687 is a novel pan-RGD integrin antagonist currently being developed as a potential treatment for patients with diabetic eye disease. Read more.
SOURCE: Oxurion, September 2019
AERIE INITIATES FIRST-IN-HUMAN TRIAL OF AR-13503 SUSTAINED RELEASE INTRAVITREAL IMPLANT
Aerie initiated patient dosing in a first-in-human clinical trial of the AR-13503 Sustained Release Implant in individuals with neovascular age-related macular degeneration or diabetic macular edema. The multi-arm, 24-week study is being conducted in two sequential stages. The first is a multicenter, open-label, dose escalation study of the safety and tolerability of a single intravitreal injection, using two doses in up to 12 patients. The second phase is a multicenter, single-masked, randomized, parallel group study of the safety and preliminary efficacy of low- or high-dose implants, dosed as monotherapy and in combination with aflibercept (Eylea, Regeneron), compared with aflibercept alone. Read more.
Source: Aerie Pharmaceuticals, August 2019
ProQR Receives Fast Track Designation from FDA for QR-1123 for Autosomal Dominant Retinitis Pigmentosa
ProQR Therapeutics N.V. received Fast Track designation from FDA for QR-1123, a first-in-class investigational antisense oligonucleotide designed to address the underlying cause of vision loss associated with autosomal dominant retinitis pigmentosa due to the P23H mutation in the rhodopsin gene. Fast Track designation is granted by the FDA to drugs in development for serious conditions with the potential to fulfill an unmet medical need. Read more.
SOURCE: ProQR Therapeutics, September 2019
REGENXBIO ANNOUNCES AGREEMENT WITH CLEARSIDE
Regenxbio announced an option and license agreement for exclusive worldwide rights to Clearside's proprietary, in-office SCS Microinjector for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration, diabetic retinopathy and other conditions for which anti-vascular endothelial growth factor treatment is currently the standard of care. Regenxbio plans to evaluate RGX-314 using Clearside's SCS Microinjector for in-office, non-surgical delivery into the suprachoroidal space, while continuing to advance its RGX-314 subretinal delivery program currently in development for wet AMD and DR. Read more.
SOURCE: Regenxbio, September 2019
NEW FUNDUS CAMERA FROM ESSILOR
Essilor Instruments now offers the Retina800 Next-Generation Fundus Camera, which the company says is designed to help streamline retinal screening in your practice. Essilor says the unique optical design allows fast, fully automatic, high-quality image capture without human intervention; operator training is minimal. The Retina800 captures 45-degree, true-color images in a few seconds with the press of a button, even if the patient has opacities or a pupil as small as 2.5 mm. Ninety-degree mosaic imaging is easily accomplished, the company adds.
Other features include:
• an intuitive user interface;
• image quality validation before storage;
• direct connection to a DICOM server;
• a space-saving, compact footprint; and
• an intuitive tablet interface. Read more.
SOURCE: Essilor Instruments, September 2019
CANON XEPHILIO OCT-A1 OCT DEVICE RECEIVES FDA 510(K) CLEARANCE
Canon announced its Xephilio OCT-A1 optical coherence tomography device is now approved. The device, which features automated acquisition functionality, is indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer and optic disc. It has a scanning speed of 70,000 A-scans per second, with optical depth resolution of approximately 3 µm. With its integrated scanning laser ophthalmoscopic and real-time retinal tracking technology, the system automatically retains the scan position and scan protocol for each patient from one exam to the next. The positioning of the components enables the operator and patient to sit side-by-side to help personalize the interaction, the company says. Read more.
SOURCE: Canon U.S.A., September 2019
FOUNDATION FIGHTING BLINDNESS INVESTS $6.5 MILLION IN NEW GRANTS
The Foundation Fighting Blindness has committed $6.5 million for 14 new research projects for inherited retinal diseases. The newly funded research efforts include development of a CRISPR/Cas9 therapy for retinitis pigmentosa, a retinal imaging technique using artificial intelligence and several therapies that the Foundation says have strong potential to treat a wide range of inherited retinal diseases. Read more.
SOURCE: Foundation Fighting Blindness, August 2019
PREVENT BLINDNESS CREATES EDUCATIONAL RESOURCE FOR DIABETES
To educate patients on diabetic eye diseases, Prevent Blindness has created the “Diabetes and the Eyes” toolkit, available in English and Spanish. The materials include:
• Educator course – for health-care professionals, community health and diabetes educators, and anyone in a caregiving or diabetes education role.
• Fact sheets – with general information about symptoms and risks; and diagnosis, treatment and prevention strategies to educate patients and the public.
• Infographics – shareable graphics designed to educate patients and the public. Users are encouraged to post messages with #VisionandDiabetes.
• Assistance resources – to help patients find the eye care they require by understanding barriers to access, ways to navigate health-care systems and the intricacies of health insurance.
The English version has received “Favorably Reviewed Approval” from the American Association of Diabetes Educators. The materials were made possible by funding from the Allergan Foundation. Read more.
Source: Prevent Blindness, August 2019
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