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.
Real-World Evidence Study of Patients with nAMD
Researchers characterized real-world baseline visual acuity and anti-vascular endothelial growth factor treatment patterns in U.S. neovascular age-related macular degeneration patients between 2012 and 2015, as part of a retrospective, multicenter, non-interventional real-world evidence study.
They analyzed data on 98,821 eyes from 79,885 patients receiving intravitreal anti-VEGF therapy. They remotely extracted up to five years of routinely collected, anonymized patient data from 58 U.S. centers to a central database using an electronic medical records system.
Main outcome measures included baseline VA, VA change from baseline, treatment frequency, annual anti-VEGF injections, bilateral treatment frequencies, annual total clinic visits and non-injection clinic visits. Baseline characteristics were comparable across years. Here were some of the findings:
• Similar mean (SD) baseline VAs were: for 2012 (53.6 [23.3]); 2013 (53.2 [23.4]); and 2014 (53.1 [23.6]) ETDRS letters; mean (SD) baseline VAs were lower for 2015 (50.7 [24.4]) ETDRS letters.
• In eyes with four-year follow-up, VA changes from baseline (LS mean [CI]) were: for year one: +1.1 (CI, 1 to 1.3); for year two: -1.3 (CI, -1.5 to -1); for year three: -3.1 (CI, -3.5 to -2.7); and for year four: -5.2 (CI, -6 to -4.3) ETDRS letters for years one to four.
• Mean (SD) number of injections was: for year one: 7.5 (1.9); for year two: 6.7 (2.1); for year three: 6.6 (2.3); and for year four: 6.4 (2.3).
• By year four, 36.7 percent of eyes had ≤8-week dosing intervals (q8w), and 21.2 percent had ≥12-week dosing intervals.
• Eyes treated <q8w increased 40 percent from year one (32.4 percent) to year four (45.3 percent).
• Baseline bilateral treatment frequency was 6.1 percent. Of the patients treated bilaterally, 32 percent received the first treatment in the better-seeing eye, and 68 percent received first treatment in an eye with vision the same as or worse than the fellow-eye. This trend was evident across all index years.
The researchers concluded that their real-world study described the treatment burden, initiation and monitoring patterns, and VA outcomes at a scale and timeframe that has not previously been reported. In this cohort, baseline VA was similar for the index years 2012 to 2014, but lower for 2015. Researchers found that, in patients with four-year follow-up, both VA and injection frequency declined, whereas the proportion of eyes treated more frequently than the recommended q8w dosing interval increased. They added that a reduction in dosing intervals may be a consequence of intensification of treatment due to year-over-year VA loss and disease progression.
Source: Khanani AM, Skelly A, Bezlyak V, et al. A retrospective, real-world evidence study of patients with neovascular age-related macular degeneration in the USA. Ophthalmology 2019; Sep 27. [Epub ahead of print].
Analysis of Macular Atrophy in HARBOR
Researchers have performed a post hoc analysis of patients from the HARBOR trial, a Phase III, multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial that compared ranibizumab administered monthly versus on an as-needed basis. Previous studies of macular atrophy in the HARBOR trial population analyzed color fundus photography and fluorescein angiography image data. The current study was based on a longitudinal assessment of monthly spectral-domain optical coherence tomography scans to determine the prevalence, incidence and progression of MA in HARBOR.
Participants included individuals (n=1,097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (treated with intravitreal ranibizumab 0.5 mg monthly (n=275); 0.5 mg pro re nata after three loading doses (PRN; n=275); 2 mg monthly (n=274); or 2 mg PRN (n=273).
In the report, masked, reading center-trained graders examined evaluable SD-OCT macular cube scans from individuals with 24 months’ follow-up (n=941) monthly from baseline to month 24. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid; retinal pigment epithelium loss; and loss of outer retinal layers. MA was considered “definite” if all three criteria were met and “questionable” if two criteria were met. Study arms were compared for time to MA detection (log-rank test) and enlargement rates (time arm interaction test).
Main outcome measures included prevalence, incidence and enlargement rates of MA. Here were some of the findings:
• At baseline, an imbalance was found in MA rates across ranibizumab arms (0.5 mg monthly, 19.1 percent; 0.5 mg PRN, 16.1 percent; 2 mg monthly, 10.1 percent; 2 mg PRN, 10.5 percent).
• At month 24, new MA development rates in eyes without baseline MA were similar between ranibizumab doses (0.5 mg, 25.9 percent; 2 mg, 25.4 percent) and treatment regimens (monthly: 26.4 percent; PRN: 25 percent).
• No significant differences were found in enlargement rates of new atrophy area (square-root transformed, p=0.479) or time to detection of new MA (p=0.997) among study arms.
In this first analysis of a major nAMD trial using the CAM atrophy criteria, researchers report that monthly vs. PRN treatment didn’t influence the incidence or progression of MA.
SOURCE: Gune S, Abdelfattah NS, Karamat A, et al. SD-OCT-based prevalence and progression of macular atrophy in the HARBOR study for neovascular age-related macular degeneration. Ophthalmology 2019; Sep 27. [Epub ahead of print].
Type-1 CNV Association with Reduced Localized Progression of Atrophy in AMD
Scientists evaluated the association between the presence of type 1 choroidal neovascularization and the localized progression of atrophy, in age-related macular degeneration. An analysis of patient data was collected from two non-interventional, prospective studies conducted at the Department of Ophthalmology, University of Bonn, Germany.
A total of 98 eyes of 59 patients (40 female, 19 male) diagnosed with AMD with a mean (±SD) age at baseline of 76.6 ±6.65 years and a median (IQR) review period of 1.17 years (CI, 1.01 to 1.55) were included. Eyes were subdivided into three categories based on multimodal imaging and on ocular history: RPE-atrophy with treatment-naïve quiescent CNV (n=7); RPE-atrophy with a history of exudative CNV (n=10); and RPE-atrophy without evidence of co-existing CNV (n=81)
Scientists delineated RPE-atrophy based on serial fundus-autofluorescence and infrared-reflectance images using RegionFinder software. If CNV was detected by optical coherence tomography angiography, they spatially mapped its location and dimension to RPE-atrophy. They then analyzed localized progression of RPE-atrophy in topographic relation to the CNV lesion using mixed-effects logistic regression. The scientists evaluated spatial overlap (Dice coefficient) between predicted and observed RPE-atrophy progression to estimate the model accuracy.
Main outcome measures included the odds ratio for localized RPE-atrophy progression in areas overlying type 1 CNV. Here were some of the findings:
• The prediction model achieved a high overlap between predicted and observed RPE-atrophy progression with a cross-validated Dice coefficient (CI) of 0.87 (0.85 to 0.89) reflecting a high accuracy.
• The odds for future RPE-atrophy involvement were reduced by a factor of CI, 0.21 (0.19 to 0.24) in the presence of treatment-naïve quiescent type 1 CNV and by the factor of 0.46 (0.41 to 0.51) in the presence of exudative type 1 CNV.
Scientists reported a markedly reduced RPE-atrophy progression in areas co-localizing with quiescent and exudative type 1 CNV. They wrote that this observation was compatible with a potential protective effect of type 1 CNV on the RPE and overlying neurosensory retina. They added that the results may have relevant clinical implications for the management of CNV and may lead to new therapeutic strategies to prevent atrophy progression.
SOURCE: Pfau M, Möller PT, Künzel SH, et al. Type-1 choroidal neovascularization is associated with reduced localized progression of atrophy in age-related macular degeneration. Ophthalmology Retina 2019; Oct 1. [Epub ahead of print].
Age-related Changes in Choroidal Thickness and Volume of Vessels and Stroma Using SS-OCT and Fully Automated Algorithms
Investigators determined age-related changes in choroidal thickness, and the volume of choroidal vessels and stroma using automated algorithms based on structural swept-source OCT scans, as part of a prospective and observational study.
They included 144 normal subjects with ages ranging from 20 to 88 years and used a previously reported strategy to automatically segment the choroid using SS-OCT structural images. Investigators applied attenuation correction on B-scans to enhance the choroidal contrast and facilitate more accurate automatic segmentation of the 3D choroidal vessel and stroma.
The parameters investigated included:
• mean choroid thickness (MCT);
• choroidal vessel volume (CVV);
• choroidal stroma volume (CSV);
• choroid vascularity index (CVI); and
• choroidal stroma-to-vessel volume ratio (CSVR).
Investigators studied correlations between MCT and choroidal vessel metrics of CVV, CSV, CVI and CSVR. They analyzed regional distributions of MCT and CVI using a grid centered on the fovea. And they looked at age-related changes in MCT, CVV, CSV and CVI in the whole scanning region, as well as in the sub-regions of the grids. Main outcome measures included age-related changes in MCT, CVV, CSV and CVI using 6×6 mm and 12×12 mm SS-OCT scans. Here were some of the findings:
• Investigators validated the automated choroid segmentations against manual segmentations, and MCT measurements were shown to be in good agreement (p<0.0001).
• CVV and CSV showed significant correlations with MCT (all p<0.0001).
• CVI and CSVR were constant with little variation between all subjects, regardless of age (61.1 ±1.8 percent) and MCT (0.64 ±0.05 percent).
• Measurements on 12×12 and 6×6 mm scans showed excellent agreement in all scan regions (all p<0.0001).
• While choroid thickness and choroid volume, which includes choroidal vessels and stroma, decreased with age (all p<0.0001), the CVI and CSVR varied little between all ages in all regions.
Investigators determined that, while MCT, CVV and CSV decreased with age, the CVI and CSVR remained constant in all regions with age. They added that ongoing studies are using these automated algorithms on SS-OCT structural datasets to investigate the diagnostic usefulness of such choroidal parameters in various ocular and systemic diseases.
Source: Zhou H, Dai Y, Lyu C, et al. Age-related changes in choroidal thickness and the volume of vessels and stroma using swept source OCT and fully automated algorithms. Ophthalmology Retina 2019; Oct 1. [Epub ahead of print].
Incomplete RPE & Outer Retinal Atrophy (iRORA) in AMD: CAM Report 4
Researchers described the defining features of “incomplete retinal pigment epithelial and outer retinal atrophy” (iRORA), a consensus term referring to optical coherence tomography-based anatomical changes often identified prior to the development of “complete RPE and outer retinal atrophy (cRORA)” in age-related macular degeneration. They provided descriptive OCT and histological examples of disease progression, as part of a consensus meeting.
Participants included a panel of retina specialists, including retinal imaging experts, reading-center leaders and retinal histologists. As part of the Classification of Atrophy Meetings (CAM) program, an international group of experts analyzed and discussed longitudinal multimodal imaging of AMD eyes. They reached consensus on a classification system for OCT-based structural alterations occurring prior to the development of atrophy secondary to AMD. And they defined terms of complete and incomplete RPE and outer retinal atrophy (iRORA and cRORA).
Main outcome measures included defining the term iRORA through OCT imaging and longitudinal cases showing progression of atrophy, with histologic correlates. OCT was used in cases of early and intermediate AMD as the base imaging modality to identify cases of iRORA.
In the context of drusen, iRORA was defined on OCT as: (1) a region of signal hypertransmission into the choroid; (2) a corresponding zone of attenuation or disruption of the RPE; and (3) evidence of overlying photoreceptor degeneration. The group clarified that the term iRORA shouldn’t be used when RPE tears are present. Longitudinal studies confirmed the concept of progression from iRORA to cRORA.
The group provided international consensus classification for OCT-defined anatomical features of iRORA, and provided examples of longitudinal progression to cRORA. They concluded that the ability to identify such OCT changes reproducibly was essential to better understanding the natural history of disease, identifying high-risk signs of progression and studying early interventions. They added that longitudinal data would be required to quantify the implied risk of vision loss associated with the terms and that the CAM classification provided initial definitions to enable such future initiatives, with the understanding that the classification would be refined as new data are generated.
SOURCE: Guymer RH, Rosenfeld PJ, Curcio CA, et al. Incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) in age-related macular degeneration: CAM Report 4. Ophthalmology 2019; Sep 30. [Epub ahead of print].
Projection-resolved OCTA-Based Metrics for Early Detection of Retinal Microvascular Impairments in Diabetes Mellitus
Researchers assessed the ability of nonperfusion, vessel density and morphologic measurements using projection-resolved optical coherence tomography angiography to detect early retinal microvasculature impairments in diabetes mellitus.
They performed a retrospective review on type 2 DM patients with no diabetic retinopathy, or mild nonproliferative DR and age-matched controls imaged with optical coherence tomography angiography. In addition, researchers measured foveal avascular zone-related metrics and extrafoveal avascular area in OCTA images. And they calculated vessel density and fractal dimension with and without a skeletonization process, and computed the vessel diameter index and vessel tortuosity. The area under the receiver operating characteristic curve estimated diagnostic performances. Here were some of the findings:
• Dilated capillary diameter was observed in the deep capillary plexus in the diabetic groups.
• The vessel density and fractal dimension of the skeletonized deep capillary plexus significantly and progressively decreased in the no DR and mild nonproliferative DR groups compared with controls.
• The AUCs of the superficial extrafoveal avascular area (0.885), vessel density (0.876) and fractal dimension of the skeletonized deep capillary plexus (0.876) had the highest diagnostic performance to differentiate mild nonproliferative DR from control eyes.
Researchers wrote that vessel density and fractal dimension from the skeletonized deep capillary network may be the most sensitive for detecting early retinal capillary loss in diabetes mellitus.
Source: Zhu TP, Li EH, Li JY, et al. Comparison of projection-resolved optical coherence tomography angiography-based metrics for the early detection of retinal microvascular impairments in diabetes mellitus. Retina 2019; Oct 1. [Epub ahead of print.]
Neuron-specific Enolase, S100B and Malondialdehyde Levels in Serum & Vitreous of PDR Patients
Researchers assessed the vitreous and serum levels of neuron-specific enolase (NSE), S100B and malondialdehyde (MDA) in proliferative diabetic retinopathy cases, and investigated the correlation between preoperative and postoperative anatomical and clinical features.
The study group included individuals who had pars plana vitrectomy for PDR. The control group included non-diabetic individuals who underwent PPV surgery for vitreoretinal interface disorders. Researchers took samples of serum from all participants preoperatively, and took vitreous samples during the PPV. They measured vitreous and serum levels of NSE, S100B and MDA, and made comparisons between the groups.
The study group consisted of 56 eyes of 56 cases with PDR. The control group consisted of 20 eyes of 20 cases. Concentrations in the markers were significantly higher than in the control group in vitreous NSE (p<0.0001), S100B (p<0.05) and MDA (p<0.001). Serum levels were statistically different for NSE and S100B (p<0.05).
Researchers wrote that the vitreous levels of S100B, NSE and MDA, and serum concentrations of NSE and S100B, increased significantly in individuals with PDR. They added that their findings may indicate neurodegeneration and oxidative stress such that the markers could have a diagnostic value in patients with PDR.
Source: Asadova V, Gul Z, Buyukuysal RL, et al. Assessment of neuron-specific enolase, S100B and malondialdehyde levels in serum and vitreous of patients with proliferative diabetic retinopathy. Int Ophthalmol 2019; Sep 30. [Epub ahead of print].
Clinical Outcomes of Different DME Components on OCT
Scientists evaluated the edema reduction after intravitreal injection of ranibizumab in two diabetic macular edema components in the same eye, using optical coherence tomography.
A total of 113 eyes with mixed OCT patterns of DME were included. All eyes underwent best-corrected visual acuity examination and OCT scanning at baseline and follow-up visits (one, three and six months after three monthly consecutive IVR). Scientists classified the mixed OCT pattern of DME into two OCT components: serous retinal detachment (SRD) component and non-SRD component. They compared foveal thickness of the SRD component (SRDFT) and the non-SRD component (NSRDFT) between baseline and follow-up visits. They compared reduction and reduction ratio of the SRDFT and the NSRDFT at each follow-up. In addition, the scientists, when calculating the NSRDFT reduction ratio, optimized a commonly used formula by subtracting the normal foveal thickness from the baseline NSRDFT. Here were some of the findings:
• SRDFT was 265.6 ±175.4 μm at baseline and was significantly decreased to 126.7 ±114.4 μm at one month, to 110.5 ±103.4 μm at three months and to 110.4 ±89.6 μm at six months (all p<0.001).
• NSRDFT was 409.5 ±173.1 μm at baseline and was significantly decreased to 274.1 ±140.4 μm at one month, to 249.1 ±95.9 μm at three months and to 254.1 ±90.4 μm at six months (all p<0.001).
• No significant differences in reduction or reduction ratio were found between NSRDFT and SRDFT during follow-up (all p>0.05).
• The correlation between BCVA and SRDFT was most significant at baseline (r=0.366, p<0.001), and the correlation between BCVA and NSRDFT was most significant at six months (r=0.426; p<0.001).
• BCVA improvement was more significantly correlated with reduction or reduction ratio of SRDFT at each follow-up time point (r=0.271-0.426; all p<0.01).
Scientists reported that the IVR was effective in reducing the SRD and non-SRD components of DME, according to their optimized formula. They added that the association between BCVA improvement and edema reduction was more significant in the SRD component.
SOURCE: Hu Y, Wu Q, Liu B, et al. Comparison of clinical outcomes of different components of diabetic macular edema on optical coherence tomography. Graefes Arch Clin Exp Ophthalmol 2019; Sep 16. [Epub ahead of print].
Anti-VEGF Therapy and Risk of Traction Retinal Detachment in PDR Eyes
Researchers assessed whether anti-vascular endothelial growth factor for diabetic macular edema or proliferative diabetic retinopathy increased the risk of traction retinal detachment (TRD) among eyes with PDR.
They used a pooled analysis of PDR eyes from Protocols I, J, N, S or T with Early Treatment Diabetic Retinopathy Study level ≥61 (prompt vitrectomy wasn’t planned) randomly assigned to the control group (laser photocoagulation, sham or intravitreal saline; 396 eyes) or anti-VEGF (487 eyes). The primary outcome was investigator-identified TRD within one year of randomization. Here were some of the findings:
• The one-year cumulative probability of TRD was 6.8 percent (CI, 4.6 to 9.9 percent; 25 events) in control eyes and 4.8 percent (CI, 3.2 to 7.3 percent; 22 events) in anti-VEGF eyes (HR=0.95 [CI, 0.54 to 1.66; p=0.86]).
• The cumulative probability of vitrectomy for TRD was 4.4 percent (16 events) in control eyes and 2.2 percent (nine events) in anti-VEGF eyes (p=0.19).
• The percentages with TRD and vitrectomy for TRD were similar within the strata of DR severity.
Researchers determined that the findings didn’t support the hypothesis that anti-VEGF therapy for DME or PDR increased the risk of TRD among eyes with PDR similar to those enrolled in five DRCR Retina Network protocols, in which prompt vitrectomy wasn’t planned.
SOURCE: Bressler N, Beaulieu WT, Bressler SB, et al. Anti-vascular endothelial growth factor therapy and risk of traction retinal detachment in eyes with proliferative diabetic retinopathy. Retina 2019; Sep 17. [Epub ahead of print].
Outcomes of Outpatient Vitrectomy for PDR
Investigators compared postoperative outcomes of 27-ga and 25-ga. vitrectomy conducted as outpatient surgery for proliferative diabetic retinopathy. They analyzed 185 consecutive PDR patients (185 eyes) who underwent primary vitrectomy (27-ga. in 64 eyes, 25-ga. in 121 eyes).
Here were some of the findings:
• The 27- and 25-ga. groups didn’t differ significantly in preoperative Early Treatment Diabetic Retinopathy Study score, age or preoperative intraocular pressure.
• The proportions of simultaneous cataract surgery (27-ga. vs. 25-ga.: 59.4 vs. 62.4 percent) and air-filled eyes (76.6 vs. 85.1 percent) weren’t significantly different between the two groups.
• Both groups showed significant improvement in ETDRS scores at postoperative one, three and six months (all, p<0.0001).
• Mean gain in ETDRS score from baseline was apparently better in the 27-ga. group than in 25-ga. group at one, three and six months, but no significant differences were detected (one month: 20.3 vs. 13.1 letters, p=0.0703; three months: 22.9 vs. 17.5 letters, p=0.1561; six months: 24.3 vs. 19.3 letters, p=0.3313).
• Operation time was apparently longer for 27-ga. vitrectomy, but no significant differences were detected (54 vs. 51.1 minutes, p=0.3676).
• The same was observed for postoperative intraocular pressure at postoperative day one (19.7 vs. 18.1 mmHg; p=0.1353).
• Incidence of postoperative retinal detachment (1.6 vs. 0.8 percent) and reoperation due to vitreous hemorrhage (6.3 vs. 6.6 percent) wasn’t different between the two groups.
Investigators concluded that the 27-ga. system was as safe and as useful as the 25-ga. system when used for PDR and could be expected to achieve earlier recovery of postoperative visual acuity.
SOURCE: Naruse Z, Shimada H, Mori R, et al. Surgical outcomes of 27-gauge and 25-gauge vitrectomy day surgery for proliferative diabetic retinopathy. Int Ophthalmol. 2019 Sep;39:9:1973-80.
NEW WET AMD TREATMENT APPROVED: NOVARTIS’ BROLUCIZUMAB
FDA just approved Novartis’ Beovu (brolucizumab-dbll) for the treatment of wet age-related macular degeneration. Novartis says Beovu is the first anti-VEGF recommended to start eligible patients on up to three-month dosing intervals immediately following a three-month loading phase. Beovu’s approval is based on results from the Phase III HAWK and HARRIER studies, which compared the efficacy and safety of Beovu with aflibercept (Eylea, Regeneron). Beovu met the primary endpoint of these trials, which was non-inferiority in average change in best-corrected visual acuity from baseline to week 48. In addition to the possibility of longer treatment intervals for eligible patients, Beovu demonstrated greater reductions in central subfield thickness—an indicator of fluid in the retina—when compared to aflibercept, Novartis says. Learn more.
Source: Novartis, October 2019
Allergan & Molecular Partners Present Data from Phase III Trials
Allergan and Molecular Partners announced two-year data from CEDAR and SEQUOIA clinical studies of investigational Abicipar in patients with neovascular age-related macular degeneration. In the second year of these studies, four injections of Abicipar resulted in the maintenance of visual gains comparable with monthly ranibizumab. CEDAR and SEQUOIA are identical global Phase III studies to assess the efficacy and safety of Abicipar 8-week and 12-week treatment regimens compared with monthly ranibizumab in treatment-naïve patients with nAMD. Read more.
SOURCE: Allergan, Molecular Partners October 2019
GENENTECH/ROCHE PRESENTS PHASE II LADDER TRIAL DATA, COMPLETES PATIENT ENROLLMENT IN PHASE III YOSEMITE & RHINE TRIALS
At the American Academy of Ophthalmology annual meeting and Retina Subspecialty Day (Oct. 11 to 15) in San Francisco, Genentech/Roche presented data on the Ladder Phase II Trial of the Investigational Port Delivery System with ranibizumab in wet AMD. In the study, patients randomized to the 100 mg/mL PDS group had an average time to the first required implant refill of 15.8 months, and nearly half of patients in this group completed the study without needing a refill.
In addition, Genentech/Roche completed patient enrollment ahead of schedule for the Phase III YOSEMITE and RHINE clinical trials investigating faricimab in diabetic macular edema. Faricimab is a bispecific antibody designed specifically for the treatment of retinal eye diseases. The investigational medicine simultaneously binds to and neutralizes angiopoietin-2 and vascular endothelial growth factor A, and may lead to improved and sustained efficacy at longer treatment intervals the companies say.
In addition, Genentech-Roche scientists have reportedly developed the first deep learning model that can predict which patients with diabetic retinopathy will progress the fastest based on images of the retina taken at a single doctor visit, according to a paper published in the Sept. 20 online edition of the open-access journal Nature Digital Medicine. With this technology, the companies say, ophthalmologists might better tailor treatment by knowing whether a patient’s condition is likely to progress in one to two years. They add that, for clinical trials, the predictive algorithm could be used to help stratify patients based on speed of progression. Read more.
Source: Genentech-Roche, October and September 2019
RegenxBio Announces Additional Positive Phase I/IIa Trial Update for RGX-314
RegenxBio announced interim data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration, presented at Retina Subspecialty Day at the American Academy of Ophthalmology annual meeting in San Francisco. As of October 9, RGX-314 continued to be well-tolerated across all cohorts, with no drug-related serious adverse events reported, the company says. There have been no reports of clinically determined immune responses, drug-related ocular inflammation or post-surgical inflammation beyond what would be expected following routine vitrectomy, RegenxBio adds. Read more.
SOURCE: REGENXBIO, October 2019
Kodiak Announces Positive Findings from Phase Ib Study of KSI-301
Kodiak Sciences announced promising safety, efficacy and durability data from its ongoing Phase 1b study of its investigational therapy KSI-301 in patients with treatment-naïve wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. The results were presented at the AAO annual meeting's Retina Subspecialty Day. Kodiak says its objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases, and enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. Read more.
SOURCE: Kodiak, October 2019
IRIS Partners with Remidio
Intelligent Retinal Imaging Systems announced a partnership with Remidio Innovative Solutions, an ISO13485-certified integrated medical device and artificial intelligence company, to bring their smartphone-based non-mydriatic fundus camera to the U.S. market. Coupling the IRIS software and services program with an affordable handheld camera is intended to enable more service providers to adopt a telemedicine program into their practices to examine, detect and diagnose retinal disease in diabetic patients. Read more.
SOURCE: Remidio, October 2019
OCULAR THERAPEUTIX ANNOUNCES PERMANENT J-CODE FOR DEXTENZA
Ocular Therapeutix announced the Centers for Medicare and Medicaid Services issued a permanent product-specific J-code for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. Under the Healthcare Common Procedure Coding System, the J-code (J1096) became effective Oct. 1, and replaces the previously issued C-code for Dextenza (C9048). Read more
SOURCE: Ocular Therapeutix, October 2019
AAO & VERANA HEALTH OFFER GENETIC TESTING
The American Academy of Ophthalmology and Verana Health are offering no-cost genetic testing and counseling for patients with certain inherited retinal diseases through Verana Trial Connect, a cloud-based application that the organizations say broadens physician and patient awareness of clinical trial opportunities. Using information from the AAO’s Intelligent Research in Sight Registry, Verana Trial Connect aims to accelerate trial enrollment. Read more
SOURCE: AAO & Verana Health, October 2019
SECOND SIGHT ANNOUNCES $2.4 MILLION NIH GRANT
Second Sight Medical Products announced receipt of a $2.4 million, four-year grant from the National Institutes of Health to develop spatial localization and mapping technology (SLAM). A joint collaboration with the Johns Hopkins University Applied Physics Laboratory, the initiative is intended to speed the integration of SLAM into next-generation versions of the Orion Visual Cortical Prosthesis System, the company says. Read more.
SOURCE: Second Sight Medical Products, October 2019
ALDEYRA THERAPEUTICS RECEIVES FAST TRACK DESIGNATION FOR ADX-2191
Aldeyra Therapeutics announced the FDA granted fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy. Aldeyra expects to initiate its adaptive Phase III GUARD Trial of ADX-2191 for the prevention of PVR in the fourth quarter of 2019. The trial will compare recurrence rates of PVR-related retinal detachment across individuals treated with ADX-2191 or standard of care following surgical repair of retinal detachment. ADX-2191, an intravitreal formulation of methotrexate, was granted orphan drug designation for the prevention of PVR. Read more
SOURCE: Aldeyra Therapeutics, September 2019
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