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.
Intravitreal Anti-VEGF Cost Savings with Increased Bevacizumab Reimbursement & Utilization
Scientists modeled Medicare Part B and patient savings associated with increased bevacizumab payment and utilization for intravitreal anti-vascular endothelial growth factor therapy, as part of a cost analysis.
They used Medicare claims and IRIS Registry data to calculate Medicare Part B expenditures and patient co-pays for anti-VEGF agents with increasing reimbursement and utilization of bevacizumab relative to ranibizumab and aflibercept. Main outcome measures included Medicare Part B costs and patient co-pays for anti-VEGF agents in the Medicare fee-for-service population.
The scientists found that increasing bevacizumab reimbursement to $125.78—equalizing the dollar margin with aflibercept—would result in Medicare Part B savings of $468 million and patient savings of $119 million, with a 10-percent increase in bevacizumab market share.
The scientists reported that increased utilization of bevacizumab, achievable with increased reimbursement to eliminate the financial disincentive to its use, would result in substantial savings to the Medicare Part B program and to patients receiving anti-VEGF intravitreal injections.
SOURCE: Glasser DB, Parikh R, Flora Lum F, et al. Intravitreal anti-vascular endothelial growth factor cost savings achievable with increased bevacizumab
“Trinity” Regimen with Aflibercept for Treatment-naïve nAMD: 2-Year Outcomes
Researchers evaluated the advantages of the so-called trinity regimen for treatment-naïve neovascular age-related macular degeneration, which involves using three treatment methods— pro re nata, treat-and-extend (TAE) and fixed regimen—that are changed depending on recurrence frequency. Thirty-one treatment–naïve nAMD eyes were treated using the novel regimen with an intravitreal aflibercept injection and evaluated after 24 months.
After the initial treatment, PRN or TAE (for four or eight weeks) were selected per the recurrence interval. When the recurrence interval became constant, the treatment regimen was transitioned from a TAE to a fixed regimen. When the recurrence frequency became irregular, it was changed to TAE. Here were some of the findings:
- After the initial treatment:
- 15 eyes (48.4 percent) were assigned to the PRN group;
- 12 (38.7 percent) were assigned to the TAE eight-week group; and
- four (12.9 percent) were assigned to the TAE four-week group.
- Mean logMAR vision significantly improved from 0.53 ±0.40 at baseline to 0.36 ±0.34 at 24 months (p<0.01) (from a little worse than 20/63 at baseline to just above 20/50):
- in the PRN group, it went from 0.63 ±0.46 to 0.42 ±0.43, (p<0.01) (from a little worse than 20/80 at baseline to a bit worse than 20/50); and
- in the TAE eight-week group it improved from 0.44 ±0.29 to 0.27 ±0.19 (p<0.05) (from a little worse than 20/50 at baseline to just above 20/40).
- LogMAR visual acuity in the TAE four-week group was maintained.
- The mean number of injections were: for all, 9.7; PRN, 5.3; TAE 8-week, 13.1; and TAE four-week group 15.8, with the PRN group being significantly less (p<0.01).
Researchers concluded that the trinity regimen delivered the benefits of the PRN, TAE and fixed regimens while minimizing injections during the early treatment phase without visual loss.
SOURCE: Wakuta M, Nomi M, Ogata T, et al. A Trinity regimen with aflibercept for treatment-naïve neovascular age-related macular degeneration: 2-year outcomes. Graefes Arch Clin Exp Ophthalmol 2020; May 21. [Epub ahead of print].
U.K. Researchers Test Automated Screening
Researchers in London compared the performance of an Automated retinal image analysis software, EyeArt (Eyenuk, Woodland Hills, Calif.) to human grading.
The researchers performed imaging with mydriasis (two-field protocol) with the EIDON platform (CenterVue, Padua, Italy) and standard National Health Service Diabetic Eye Screening Programme fundus cameras. Human grading was carried out according to NDESP protocol. Images were processed by the EyeArt V.2.1.0 system. The reference standard for analysis was the human grade of standard NDESP images.
In 1,257 patients, the sensitivity estimates for retinopathy grades were: EIDON images; 92.27 percent for any retinopathy, 99 percent for vision-threatening retinopathy and 100 percent for proliferative retinopathy. For NDESP images: 92.26 percent for any retinopathy, 100 percent for vision-threatening retinopathy and 100 percent for proliferative retinopathy. One case of vision-threatening retinopathy was missed by the EyeArt when analysing the EIDON images, but it was identified by the human graders. The EyeArt identified all cases of vision-threatening retinopathy in the standard images.
The researchers say the EyeArt identified diabetic retinopathy in EIDON images with similar sensitivity to standard images in a large-scale screening program, exceeding the sensitivity threshold recommended for a screening test. They add that further work to optimize the identification of ‘no retinopathy’ and to understand the differential lesion detection in the two imaging systems would enhance the use of these two new technologies.
Source: Olvera-Barrios A, Heeren TF, Balaskas K, et al. Diagnostic accuracy of diabetic retinopathy grading by an artificial intelligence-enabled algorithm compared with a human standard for wide-field true-colour confocal scanning and standard digital retinal images. Br J Ophthalmol 2020; May 6 [Epub ahead of print].
Association of CRP Levels with ARMS2 and CFH Variants in AMD
Researchers assessed whether plasma high-sensitivity C-reactive protein (hs-CRP) levels were associated with exudative age-related macular degeneration as well as variants of ARMS2 A69S and CFH I62V in patients with exudative AMD.
They conducted a case-control study comparing CRP with exudative AMD including individuals with polypoidal choroidal vasculopathy, typical AMD, retinal angiomatous proliferation and CRP. Researchers measured plasma CRP from peripheral blood using latex nepherometry for all participants. They performed genotyping of ARMS2 A69S and CFH I62V for all patients with exudative AMD using TaqMan technology. Here are some of the findings:
- Among 125 individuals with exudative AMD, including 31 with typical neovascular AMD, 73 with PCV and 21 with RAP lesions and 150 controls, CRP levels were higher in exudative AMD than in controls (p=2.7 × 10 to 5).
- No significant differences were found in hs-CRP levels among AMD subtypes.
- Neither variants of ARMS2 nor CFH were associated with hs-CRP levels in patients with exudative AMD.
- A multiple regression analysis revealed that male sex, presence of exudative AMD and presence of cardiovascular diseases were associated with increased plasma hs-CRP.
Researchers found that plasma hs-CRP was elevated independent of variants of ARMS2 A69S and CFH I62V in patients with exudative AMD.
Source: Shijo T, Sakurada Y, Fukuda Y, et al. Association of CRP levels with ARMS2 and CFH variants in age-related macular degeneration. Ophthalmology Retina 2020; June 7. [Epub ahead of print].
Long-term Intravitreal Anti-VEGF Injections for Wet AMD
Researchers determined the long-term visual outcomes and intravitreal injection burden of individuals with exudative age-related macular degeneration treated with intravitreal anti-vascular endothelial growth factor injections, as part of a retrospective, cohort study.
Participants included individuals with exudative AMD treated with intravitreal anti-VEGF injections with annual office visits for at least seven years.
Researchers measured Snellen visual acuity at baseline and then annually until the last year of follow-up. The number of injections was recorded on an annual basis during each year of follow-up. Main outcome measure included the change in the frequency of injections over time along with the change in visual acuity each year from the baseline visit up through seven years.
During this time, a total of 533 eyes of 429 patients were treated for wet AMD. Of these eyes, 391 eyes (73 percent) met the inclusion criteria of annual office visits. Here are some of the findings:
• These included eyes received a mean of 5.8 ±2.5 intravitreal injections per year.
• The baseline mean logMAR visual acuity was 0.6 ±0.5 (Snellen acuity 20/80), and the seven-year logMAR visual acuity was 0.8 ±0.6 (20/126; p<0.0001).
• When compared to the 142 eyes that went more than a continuous 12-month period without an office visit, eyes with annual office visits had similar baseline mean visual acuity (0.7 logMAR vs. 0.6 logMAR; p=0.2102), but more injections per year (p<0.0001).
• Of the 533 total eyes, 124 eyes (23 percent) maintained better than 20/40 visual acuity at seven years.
• These eyes received more injections overall per year (6.5 vs. 5.5 per year; p=0.0007).
In a real-world setting, researchers found that eyes that maintained consistent, long-term follow-up received a significant number of intravitreal injections per year—significantly more than eyes with inconsistent follow up. They also reported that eyes with 20/40 or better vision at the study’s conclusion received more injections per year than eyes with worse than 20/40 vision.
Source: Kung FF, Starr MR, Bui YT, et al. Long term follow-up of patients with exudative age-related macular degeneration treated with intravitreal anti-vascular endothelial growth factor injections. Ophthalmology Retina 2020; May 18. [Epub ahead of print].
Changes in Choroidal Thickness from CNV
Scientists evaluated topographic changes in choroidal thickness during development of choroidal neovascularization in treatment-naive age-related macular degeneration and tested the value of such changes as a predictive tool of CNV development.
This retrospective cohort included 86 eyes that developed CNV from intermediate AMD, 43 eyes with intermediate AMD and 36 eyes without AMD. Patients with intermediate AMD underwent spectral-domain optical coherence tomography using enhanced depth imaging mode every six months until CNV was detected. Choroidal neovascularization was localized to one of the subfields of the Early Treatment of Diabetic Retinopathy Study grids on fluorescein angiography. The average choroidal thickness of each subfield was calculated. Here were some of the findings:
- The choroidal thickness of the subfield where CNV developed at first clinical detection significantly increased compared with that six months before (p=0.000 for central, p=0.001 for superior parafoveal, p=0.002 for temporal parafoveal, p=0.002 for inferior parafoveal and p=0.001 for nasal parafoveal subfield).
- In eight individuals who visited unexpectedly three months before CNV development in the central subfield, the choroidal thickness of the central subfield increased significantly compared with that six months before CNV development (p=0.001).
Scientists found that choroidal neovascularization development accompanied choroidal thickening of the corresponding subfield. They added that regular measurement of choroidal thickness may assist in prediction of CNV.
SOURCE: Park JY, Kang M-J, Kim BGi, et al. Topographic changes in choroidal thickness in age-related macular degeneration during the development of active choroidal neovascularization. Ophthalmology Retina 2020; May 18. [Epub ahead of print].
Deep Learning Automated Detection of Reticular Pseudodrusen from Fundus Autofluorescence Images or Color Fundus Photographs in AREDS2
Investigators developed and evaluated deep learning models for detecting reticular pseudodrusen (RPD) using fundus autofluorescence (FAF) images or color fundus photographs (CFP), in the context of age-related macular degeneration.
They applied deep learning models to the Age-Related Eye Disease Study 2 (AREDS2) dataset, and included 11,535 FAF and 11,535 CFP images from longitudinal follow-up of 2,450 participants in the AREDS2 dataset. They derived Gold standard labels from reading center grading of the FAF images and transferred them to the corresponding CFP images. They also trained a deep learning model to detect RPD in eyes with intermediate to late AMD, using FAF images (FAF model). Using labels transferred from FAF to corresponding CFP images, they trained a second deep learning model to detect RPD from CFP (CFP model). Investigators compared model performance with that of four ophthalmologists using a random subset from the full test set. Main outcome measures included area under the curve; kappa; accuracy; and F1-score.
Here were some of the findings:
- On the full test set, the FAF model had:
- AUC: 0.939 (CI, 0.927 to 0.950);
- kappa: 0.718 (CI, 0.685 to 0.751);
- accuracy: 0.899 (CI, 0.887 to 0.911); and
- F1-score: 0.783 (CI, 0.755 to 0.809).
- The CFP model had equivalent values of:
- AUC: 0.832 (CI, 0.812 to 0.851);
- kappa: 0.470 (CI, 0.426 to 0.511);
- accuracy: 0.809 (CI, 0.793 to 0.825); and
- F1-score: 0.593 (CI, 0.557 to 0.627).
- The FAF model demonstrated superior performance to the four ophthalmologists on the random subset, showing:
- higher kappa of 0.789 (CI, 0.675 to 0.875) vs. range CI, 0.367 to 0.756;
- higher accuracy of 0.937 (CI, 0.907 to 0.963) vs. range CI, 0.696 to 0.933; and
- higher F1-score of 0.828 (CI, 0.725 to 0.898) vs. range CI 0.539 to 0.795.
- The CFP model demonstrated superior performance to the ophthalmologists on the random subset, showing:
- higher kappa of 0.471 (CI, 0.330 to 0.606) vs. range CI, 0.105 to 0.180;
- higher accuracy of 0.844 (0.798-0.886) vs. range CI, 0.717 to 0.814; and
- higher F1-score of 0.565 (CI, 0.434 to 0.674) vs. range CI, 0.217 to 0.314.
Investigators found that deep learning-enabled automated detection of RPD presence from FAF images achieved a high level of accuracy—equal or superior to that of ophthalmologists. They also reported that automated RPD detection using CFP achieved a lower accuracy that still surpassed that of ophthalmologists. As such, the investigators determined that deep learning models can assist, and even augment, the detection of this AMD-associated lesion.
SOURCE: Keenan TD, Chen Q, Peng Y, et al. Deep learning automated detection of reticular pseudodrusen from fundus autofluorescence images or color fundus photographs in AREDS2. Ophthalmology 2020; May 20. [Epub ahead of print].
Haller’s Vessels Patterns in Non-nAMD
Researchers assessed the optical coherence tomography en face reconstruction of the choroid in different phenotypes of non-neovascular age-related macular degeneration to identify the relative distribution of the vascular patterns of the Haller’s layer in each AMD category.
The retrospective study enrolled consecutive patients with non-neovascular AMD. Patients were divided into the following:
- those with reticular pseudodrusen (RPD);
- those with small (<63 μm) or medium–large drusen (63 to 124 μm); and those with geographic atrophy.
Qualitative analysis of the en face images provided by Cirrus HD-OCT 5000 (Carl Zeiss Meditech) was performed, identifying five arrangements of Haller’s vessels: temporal herringbone, branched from below, laterally diagonal, double arcuate and reticular. Choroidal thickness was measured from structural OCT. Healthy age-matched subjects were included as a control group.
A total of 58 eyes of 58 patients (20 eyes with RPD; 22 eyes with drusen; 16 eyes with GA) and 18 control eyes were enrolled. Here were some of the findings:
- The laterally diagonal configuration was the most prevalent (40 percent) in the RPD group.
- The reticular pattern was the most frequent in the drusen group (50 percent).
- The double arcuate (62.5 percent) was the most recurrent pattern in patients with GA.
- In the control group, the temporal herringbone (38.9 percent) arrangement was the most represented.
- The CT associated with the temporal herringbone and reticular arrangement was significantly higher compared to the branched from below (p<0.001), the laterally diagonal (p=0.014) and the double arcuate pattern (p=0.009).
Researchers wrote that different phenotypes of non-neovascular AMD present a specific distribution of vascular arrangement on en face OCT. They reported that the temporal herringbone and the reticular pattern (the ones more associated in a physiological setting) disclosed a thicker choroid compared with the arrangements more represented in non-neovascular AMD-correlated phenotypes.
SOURCE: Sacconi R, Cicinelli MV, Borrelli E, et al. Haller’s vessels patterns in non-neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 2020; June 13. [Epub ahead of print].
Findings from The EYE-RISK Consortium
As part of a case-control association analysis, researchers aimed to identify metabolites associated with age-related macular degeneration. In addition, they looked at the effect of AMD-associated genetic variants on metabolite levels, and investigated associations between identified metabolites and activity of the complement system—one of the main AMD-associated disease pathways.
A total of 2,267 AMD cases and 4,266 controls from five European cohorts were included. Researchers used a high-throughput H-NMR metabolomics platform to quantifiy 146 metabolite measurements and 79 derivative values. They used univariate logistic regression analyses to study metabolome-AMD associations and linear regression to study the effect of 52 AMD-associated genetic variants on identified metabolites. And they used linear regression to evaluate associations between identified metabolites and activity of the complement pathway (defined by the C3d/C3 ratio). Main outcome measures included metabolites associated with AMD.
Here were some of the findings:
- Researchers identified 60 metabolites that were significantly associated with AMD, including increased levels of large and extra-large HDL subclasses and decreased levels of VLDL, amino acids and citrate.
- Out of 52 AMD-associated genetic variants, seven variants were significantly associated with 34 of the identified metabolites.
- The strongest associations were identified for genetic variants located in or near genes involved in lipid metabolism (ABCA1, CETP, APOE, LIPC) with metabolites belonging to the large and extra-large HDL subclasses.
- In addition, 57 out of 60 metabolites were significantly associated with complement activation levels, independent of AMD status.
- Increased large and extra-large HDL levels and decreased VLDL and amino acid levels were associated with increased complement activation.
Researchers found that lipoprotein levels were associated with AMD-associated genetic variants, with strong associations between most of the AMD-associated metabolites and systemic complement activation levels, independent of AMD status. They suggested this finding may indicate biological interactions between the main AMD disease pathways and that multiple pathways may need to be targeted simultaneously for successful treatment of AMD.
SOURCE: Acar IE, Lores-Motta L, Colijn JM, MD MSc, et al. Integrating metabolomics, genomics and disease pathways in age-related macular degeneration: The EYE-RISK Consortium. Ophthalmology 2020; June 13. [Epub ahead of print].
Angiographic Evidence that Intraretinal Microvascular Abnormalities Can Evolve into Neovascularization
Scientists wrote that the hallmark of proliferative diabetic retinopathy is retinal neovascularization. Tortuous intraretinal vascular segments known as intraretinal microvascular abnormalities (IRMAs) are a known risk factor for NV, but whether IRMA represents a biomarker or a vascular precursor lesion to NV hasn’t been demonstrated. The purpose of this study was to document that IRMA may directly evolve into NV.
In a retrospective analysis of a prospective, observational case series, participants included individuals with treatment-naïve PDR. Patients were imaged longitudinally with fluorescein angiography (FA) and swept-source OCT angiography (SS-OCTA) before and after panretinal photocoagulation (PRP).
Main outcome measures included presence and co-localization of IRMA and NV on serial FA and SS-OCTA.
Here were some of the findngs:
- Two PDR patients had multiple NV and IRMA lesions at baseline examinations.
- Three months following PRP, FA demonstrated profuse leakage from three new NV lesions in one patient and one new NV lesion in another. Multimodal imaging showed that these four lesions were IRMAs at baseline.
- SS-OCTA performed before PRP and one week, one month and three months after PRP confirmed that the precursor IRMA lesions were intraretinal tortuous vascular lesions at baseline and that they developed into preretinal NV with contiguous intraretinal components.
- NV was found to develop and adhere to the posterior hyaloid even in areas of pre-existing hyaloidal detachment.
Scientists reported that diabetic retinal NV can develop from IRMA. They added that early identification of IRMAs may be an accurate means of predicting progression to PDR, and frequent monitoring of IRMAs with SS-OCTA may facilitate early diagnosis of PDR.
SOURCE: Russell JF, Shi Y, Scott NL, et al. Longitudinal angiographic evidence that intraretinal microvascular abnormalities can evolve into neovascularization. Ophthalmol Retina 2020; June 13. [Epub ahead of print].
Fluctuations in Macular Thickness in RVO Treated with Anti-VEGF Agents
Scientists evaluated macular thickness fluctuations in individuals with retinal vein occlusions treated with anti-vascular endothelial growth factor agents, and assessed whether patients with larger fluctuations had poorer visual outcomes, as part of a retrospective cohort study.
Participants included treatment-naïve patients with RVO followed over 12 months of treatment.
From optical coherence tomography technology, scientists collected central subfield thickness (CST), cube volume (CV) and cube average thickness (CAT) at baseline, three, six, nine and 12 months. They calculated standard deviations across 12 months. And they performed mixed effects regression to examine the relationship between macular thickness SD and 12-month visual acuity. In addition, they performed standard multiple regression to identify predictors of macular thickness SD.
Main outcome measures included SD across 12 months for CST, CV and CAT; and VA at 12 months. Scientists evaluated 134 eyes, including 71 branch RVO and 63 central RVO. Here were some of the findings:
- Mean baseline CST was 488.6 ±165 and mean 12-month CST was 334.3 ±131.9 (change= -154.3 ±210.2, p<0.001); CST SD was 114.1 ±77 μm.
- Baseline VA was 52.8 ±20.9 and 12-month CST was 65.9 ±17.3 (change= +13.1 ±20.3 letters; p<0.001).
- CST SD was a significant negative predictor of 12-month VA (p=0.041) when adjusting for baseline factors and injections.
- Baseline CST and number of injections weren’t predictive (p≥0.101).
- Stratification by CST SD demonstrated 10 letters difference in 12-month VA between first and fourth quartiles.
- Baseline CST and RVO diagnosis were the only significant predictors of CST SD (p<0.001) vs. BRVO (p=0.013). Associations using CV and CAT were similar.
Scientists reported that larger macular thickness fluctuations were associated with poorer visual outcomes in patients with RVO treated with anti-VEGF agents. They added that macular thickness fluctuations in addition to absolute macular thickness may be important prognostic biomarkers in these patients.
SOURCE: Chen AX, Greenlee TE, Conti TF, et al. Fluctuations in macular thickness in patients with retinal vein occlusion treated with anti-vascular endothelial growth factor agents. Ophthalmology Retina 2020; May 28. [Epub ahead of print].
FDA APPROVES UPDATED NOVARTIS BEOVU LABEL
Novartis announced the FDA approved a label update for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion. This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization of rare post-marketing Beovu safety events. The company says this is one of many efforts it’s taking to help physicians to make informed decisions on the use of Beovu, including the establishment of an internal team collaborating with global experts to examine root causes, risk factors, mitigation and potential treatment protocols for the adverse events in question. Read more.
SOURCE: Novartis, June 2020
U.S. GOVERNMENT SUES REGENERON
The U.S. Attorney’s Office in Masachusetts recently announced that the government has filed a civil False Claims Act complaint against Regeneron. The complaint alleges that “Regeneron paid tens of millions of dollars in kickbacks for its macular degeneration drug Eylea (aflibercept), using a foundation as a conduit to cover co-pays for Eylea.” For its part, in a statement Regeneron says, “There is no merit to the civil complaint filed by the U.S. Attorney for the District of Massachusetts. It is unfortunate that a misguided lawsuit is attempting to assign wrongful intent to entirely legal conduct. Regeneron has fully cooperated with the government's investigation and will vigorously defend the company's case.”
GENENTECH ANNOUNCES NEW RESULTS FROM ARCHWAY STUDY, PRESENTS SECOND WAVE OF DATA AT ARVO 2020
• Genentech announced positive topline results from the Phase III Archway study, evaluating Port Delivery System with ranibizumab (PDS) in people living with neovascular or wet age-related macular degeneration. The Archway trial met its primary endpoint, demonstrating that patients with PDS who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab 0.5 mg injections. In Archway, PDS was generally well-tolerated with a favorable benefit-risk profile. Read more.
• In addition, Genentech and Roche will be presenting a second round of findings from this year’s virtual Association for Research in Vision and Ophthalmology meeting. The findings will focus on the PDS, a new anti-HtrA1 molecule for geographic atrophy and the Personalized Healthcare program. View the video abstracts.
• As well, the ARVO Foundation’s new Genentech Career Development Award for Underrepresented Minority Emerging Vision Scientists will open to applicants on July 1. Learn more.
Source: Genentech and Roche, June 2020
SAMSUNG BIOEPIS ANNOUNCES INTERIM RESULTS FROM PHASE III PROPOSED RANIBIZUMAB BIOSIMILAR TRIAL
Samsung Bioepis announced the primary endpoints were met in its randomized, double-masked Phase III trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate in patients with neovascular age-related macular degeneration. The company says the study achieved its primary endpoints—change from baseline in best-corrected visual activity at week eight and central subfield thickness at week four. Read more.
SOURCE: Samsung Bioepis Co., May 2020
IVERIC ANNOUNCES ZIMURA 18-MONTH DATA
Iveric Bio announced 18-month results from the company's first Phase III clinical trial (OPH2003) for Zimura (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy secondary to age-related macular degeneration. The company says that the 18-month data supports the previously announced 12-month data from this trial, at which timepoint Zimura met the pre-specified primary efficacy endpoint with statistical significance. Read more.
SOURCE: IVERIC, June 2020
LINEAGE ANNOUNCES RESTORATION OF RETINAL TISSUE IN OPREGEN PHASE I/IIA STUDY
Lineage Cell Therapeutics announced that restoration of retinal tissue was observed in a patient enrolled in a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium cell transplant therapy in development for the treatment of dry age-related macular degeneration. Lineage plans to host a live call on June 8 to discuss the findings. Read more.
SOURCE: Lineage Cell Therapeutics, June 2020
FDA GRANTS 510(K) CLEARANCE FOR VASOPTIC'S RETINAL IMAGING DEVICE
Vasoptic Medical received 510(k) clearance from the FDA to market its XyCAM RI—a noninvasive retinal imager designed to capture and provide dynamic blood flow information for clinical use. The company says the XyCAM RI enables ophthalmologists to rapidly assess the vascular status of the retina. Read more.
SOURCE: Vasoptic Medical, June 2020
Scientists Rescue Mini Retinas from Eye Disease Via New Gene Therapy Approach
Scientists have known for some time that mutations in the gene RP2 are associated with retinitis pigmentosa. However, no therapies exist to treat people living with a number of RP diseases. Researchers from Trinity College Dublin and University College London teamed up with the goal of treating RP. Their results are published in Stem Cell Reports
. The team used a modified common virus to deliver a normal, functioning copy of the RP2 gene into “mini retinas,” which had been engineered from stem cells and which contained the defective version of the gene. The “mini retinas,” developed in University College London, simulated the RP2 disease in patients successfully took up the functioning RP2 gene following the viral delivery and produced the essential protein associated with it. The treated mini retinas showed significant improvement, the researchers say. Read more.
SOURCE: Trinity College Dublin, June 2020
GRAYBUG APPOINTS DR. ZAMIRI AS CHIEF MEDICAL OFFICER
Graybug Vision appointed Parisa Zamiri, MD, PhD, as the company’s chief medical officer, effective June 1, 2020. Graybug says Dr. Zamiri is a physician-scientist with “deep expertise” in pharmaceuticals. Dr. Zamiri joins Graybug Vision from Novartis, where she most recently held the position of vice president, global head of clinical development and therapeutic area head for ophthalmology. Read more.
SOURCE: Graybug Vision, May 2020
FDA REVOKES EMERGENCY USE AUTHORIZATION FOR EMERGENCY USE OF ORAL FORMULATIONS CQ & HCQ FOR COVID-19
The FDA revoked Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for certain patients with COVID-19 based on new information and clinical results concluding that this drug may not be effective to treat COVID-19 and that the drug’s potential benefits for such use do not outweigh its known and potential risks. In a letter dated June 15, 2020, to Gary L. Disbrow, PhD, deputy assistant secretary, at the Biomedical Advanced Research and Development Authority at the U.S. Department of Health and Human Services, Denise M. Hinton, chief scientist of the FDA, said the FDA had determined that the criteria under section 564(c) of the Act for issuance of the EUA were no longer met. Read more.
SOURCE: FDA, June 2020
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