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.
Systemic Health and Medication Use’s Impact on GA Rate in AMD
The associations of geographic atrophy progression with systemic health status and medication use are unclear. In this study, investigators manually delineated GA in 318 eyes in the Age-Related Eye Disease Study. They calculated GA perimeter-adjusted growth rate as the ratio between GA area growth rate and mean GA perimeter between the first and last visit for each eye (mean follow-up=5.3 years). Patients' history of systemic health and medications was collected through questionnaires administered at study enrollment. Investigators evaluated the associations between GA perimeter-adjusted growth rate and 27 systemic health factors, using univariable and multivariable linear mixed-effects regression models.
Here are some of the findings:
• In the univariable model, GA perimeter-adjusted growth rate was associated with:
o GA in the fellow eye at any visit (p=0.002);
o hypertension history (p=0.03);
o cholesterol-lowering medication use (p<0.001);
o beta-blocker use (p=0.02);
o diuretic use (p<0.001); and
o thyroid hormone use (p=0.03).
• Among the six factors, GA in the fellow eye at any visit (p=0.008), cholesterol-lowering medication use (p=0.002) and diuretic use (p<0.001) were independently associated with higher GA perimeter-adjusted growth rate in the multivariable model.
• GA perimeter-adjusted growth rate was 51.1 percent higher in patients with vs. without cholesterol-lowering medication use history, and was 37.8 percent higher in patients with a history of diuretic use vs. those without.
Investigators reported that the GA growth rate may be associated with the fellow eye status, cholesterol-lowering medication use and diuretic use. However, they added that these possible associations don’t imply causal relationships, and future prospective studies are required to investigate the relationships further.
SOURCE: Shen LL, Xie Y, Sun M, et al. Associations of systemic health and medication use with the enlargement rate of geographic atrophy in age-related macular degeneration. Br J Ophthalmol 2021; Sep 6. [Epub ahead of print].
Treatment of nAMD: An Economic Cost-Risk Analysis of Anti-VEGF agents
Investigators aimed to find the best cost-effective NVAMD treatment to improve vision while avoiding complications, using a model based on a cost-risk tradeoff analysis from policymakers' perspectives.
A simulation model was created using two years of treatment with the four commonly used anti-VEGF drugs (bevacizumab, ranibizumab, aflibercept and brolucizumab) across three injection protocols, building on prior findings that these drugs are non-inferior. The model incorporated blinding complications, their management and associated cost to society. Each option and several "what-if" scenarios were simulated 1,000 times with 100,000 hypothetical patients.
Participants included 100,000 simulated patients using data from published clinical trials in the Case- and eye-specific cost-risk economic analysis.
Main outcome measures included costs of NVAMD treatment per patient and number of eyes that become blind due to treatment over two years.
Here are some of the findings:
• Using published prices and fees on injection protocols following in clinical studies, results showed that the mean cost per patient was $16,859 ±3.65 for bevacizumab, $32,949 ±3.27 for brolucizumab, $39,831 ±3.80 for aflibercept and $53,056 ±2.99 for ranibizumab.
• The numbers of treated eyes that became blind were 108 ±10.18, 694 ±26.66, 168 ±12.83 and 108 ±10.52, respectively.
• Researchers further provided a lower bound (when all patients were maximally extended) and upper bound (when no patient was extended) to these numbers. For brolucizumab the upper bound was the two-month interval injection protocol.
Investigators wrote that taking a policymaking perspective, this study suggested that bevacizumab was the preferred first-line therapy. They added that recommendation for second-line therapy depended on the extent of the policymaker's risk-aversion because of the tradeoff between cost and risk of blindness due to treatment. In risk-neutral settings, investigators wrote further, the least expensive option (brolucizumab) was preferred. But if risk-aversion was moderate to high, then aflibercept or ranibizumab was preferred.
Source: Moisseiev E, Tsai YL, Herzenstein M. Treatment of neovascular age-related macular degeneration: an economic cost-risk analysis of anti-VEGF agents. Ophthalmol Retina 2021; Aug 25. [Epub ahead of print].
OCT Features of Polypoidal Lesion Closure in PCV Treated with Aflibercept
Researchers evaluated whether optical coherence tomography can determine polypoidal lesion (PL) perfusion in polypoidal choroidal vasculopathy eyes following 12-months of aflibercept monotherapy. They wrote that PL perfusion status, assessed by indocyanine green angiography, is an important anatomical outcome in PCV management.
Researchers used post hoc data from a prospective, randomized, open-label, study in eyes with PCV undergoing monotherapy with aflibercept to evaluate PL perfusion status based on ICGA (gold standard) and OCT features from baseline to 12-months.
Here are some of the findings:
• Individual PLs (110 in total) from 48 eyes (48 patients) showed at 12-months; 57/110 PLs (51.8 percent) were closed on ICGA.
• At 12-months, eyes with closed PLs were more likely to have the following OCT features:
o no SRF (67.1 vs. 32.9 percent);
o smaller PED height (67.2 [±43.8] vs. 189.2 [±104.9] μm);
o densely hyper-reflective PED contents (84 vs. 16 percent);
o an absence of a hyper-reflective ring (64 vs. 36 percent); and
o an indistinct overlying RPE (71.4 vs. 28.6 percent)(all p<0.05).
• The three OCT features that most reliably differentiated perfused from closed PLs were: no SRF; densely hyper-reflective PED contents; and an absence of hyper-reflective ring (area under the ROC curve, respectively: 0.85, 0.73 and 0.70). A combination of these three features achieved an AUC-ROC of 0.90.
Researchers wrote that PL closure, an important anatomical treatment outcome in PCV typically defined by ICGA, can be accurately detected by specific OCT features.
SOURCE: Tan ACS, Jordan-Yu JM, Vyas CH. Optical coherence tomography features of polypoidal lesion closure in polypoidal choroidal vasculopathy treated with aflibercept. Retina 2021; Aug 16. [Epub ahead of print].
Anti-VEGF Therapy in Treatment-naïve nAMD Diagnosed on OCTA: The REVEAL study
Investigators compared 12-month visual and anatomical outcomes of treatment-naïve neovascular age-related macular degeneration patients diagnosed by optical coherence tomography angiography compared with fluorescein angiography (FA)/indocyanine green angiography (ICGA) after anti-VEGF treatment in a real-world setting.
In a monocentric, observational, parallel-group study of nAMD patients diagnosed with either FA/ICGA or noninvasive OCTA methods, patients were treated with a fixed dosing regimen of intravitreal ranibizumab or aflibercept and followed up for 12 months. Primary outcomes were the 12 months functional (BCVA) and anatomical (CST reduction) gains between the two groups. The stratification of BCVA and CST gains by type of neovascular lesion and by anti-VEGF treatment was also assessed.
Here are some of the findings:
• Seventy-two patients received FA/ICGA for the initial diagnosis of nAMD while 73 received OCTA.
• Overall, the mean BCVA gain at 12 months was 11.5 ±9.6 letters.
• No statistically significant differences were found between the invasive and noninvasive imaging groups in BCVA gain (p=0.87) or CST reduction (p=0.76).
• No statistically significant outcome differences between different lesion types and the two drugs were observed.
Investigators reported, in a real-world setting, nAMD patients diagnosed with OCTA showed meaningful improvements in visual and anatomical parameters during 12 months of treatment, without significant differences from those diagnosed by invasive modalities.
SOURCE: Lupidi M, Schiavon S, Cerquaglia A, et al. Real-world outcomes of anti-VEGF therapy in treatment-naïve neovascular age-related macular degeneration diagnosed on OCT angiography: The REVEAL study. Acta Ophthalmol 2021; Aug 18. [Epub ahead of print].
Genetic Associations of Anti-VEGF Therapy Response in AMD
Researchers assessed the association of all reported common polymorphisms in anti-vascular endothelial growth factor therapy response and identified potential clinically useful biomarkers for anti-VEGF therapy response in patients with age-related macular degeneration.
They searched the Embase, PubMed and Web of Science databases in English, and the China National Knowledge Infrastructure, WanFang and VIP databases in Chinese for pharmacogenetics studies on anti-VEGF therapy response in AMD. Odds ratios with 95 percent confidence intervals were calculated using the random effects model.
Among the 10,468 records yielded by the literature search, 33 articles that met the eligibility criteria were included in the meta-analysis. Nine single-nucleotide polymorphisms (SNP) in four genes were observed to be associated with the anti-VEGF therapy response in AMD patients.
• The following SNPs were associated with good anti-VEGF therapy responses:
o rs1120063 in the HTRA1 gene;
o rs10490924 in the age-related maculopathy susceptibility (ARMS2) gene;
o rs1061170 in the complement factor H (CFH) gene; and
o rs323085 in the OR52B4 gene.
• The following SNPs were associated with poor anti-VEGF therapy response in the AMD patients:
o rs800292, rs1410996 and rs1329428 in the CFH gene; and
o rs4910623 and rs10158937 in the OR52B4 gene.
Researchers wrote that nine SNPs of four genes were indicated to be significantly associated with the anti-VEGF therapy response in the samples. They added that further studies based on various ethnicities and large sample sizes are warranted to strengthen the evidence found in the present study.
SOURCE: Wang Z, Zou M, Chen A, et al. Genetic associations of anti-vascular endothelial growth factor therapy response in age-related macular degeneration: A systematic review and meta-analysis. Acta Ophthalmol 2021; Aug 17. [Epub ahead of print].
Localized Choriocapillaris Perfusion & Macular Function in GA
Investigators tested the hypothesis that choriocapillaris perfusion correlates with visual function in geographic atrophy, as part of a cross-sectional, single-center study.
Investigators imaged choriocapillaris flow using 6 mm x 6 mm swept-source optical coherence tomography angiography scans and measured retinal sensitivity using fundus-guided microperimetry in the central 20 degrees in 18 eyes of 12 subjects with GA, and seven eyes of four normal subjects. OCTA scans were divided into a grid, and microperimetry results were superimposed using retinal vascular landmarks. The main outcome measure correlated choriocapillaris flow deficit with retinal sensitivity at each localized region. Robust linear mixed effects regression compared flow deficit or sensitivity with distance from the fovea. The Pearson ρ correlation described the relationship between flow deficit or retinal sensitivity and distance from the GA border.
Here are some of the findings:
• Choriocapillaris flow deficit was significantly greater in GA than normal (mean ± standard deviation 24.2 ±7.9 percent vs. 7.9 ±2.3 percent, p=0.0015), while retinal sensitivity was significantly lower in GA than normal (mean difference -17.0 ±1.2 dB, p<0.001).
• In GA, choriocapillaris flow deficit decreased (ρ=-0.40; CI, -0.54 to -0.27), while retinal sensitivity increased (ρ=+0.63; CI, 0.30 to 0.81) with distance from the GA margin.
• Choriocapillaris flow deficits inversely correlated with retinal sensitivity (ρ=-0.61; CI, -0.75 to -0.42).
Investigators found that choriocapillaris flow and retinal sensitivity improved with distance from the GA margin. Furthermore, they wrote, choriocapillaris flow deficit was inversely correlated with sensitivity, supporting the hypothesis that choriocapillaris perfusion correlated with macular function.
SOURCE: Rinella NT, Zhou H, Wong J, et al. Correlation between localized choriocapillaris perfusion and macular function in eyes with geographic atrophy. Am J Ophthalmol 2021; Aug 23. [Epub ahead of print].
Inhibition of Complement C3 in GA with NGM621
Investigators evaluated the safety and tolerability of single and multiple intravitreal injections of NGM621 in patients with geographic atrophy and characterized the pharmacokinetics and immunogenic potential in a multicenter, open-label, single- and multiple-dose Phase I study.
Fifteen patients enrolled at four sites in the United States were included. Participants had GA secondary to age-related macular degeneration, lesion size ≥2.5 mm2 and best-corrected visual acuity of four to 54 letters (20/80 to 20/800 Snellen equivalent) in the study eye and no history of choroidal neovascularization in either eye. Patients who met eligibility criteria were treated in a single ascending-dose phase (2 mg, 7.5 mg, 15 mg) or received two doses NGM621 15 mg four weeks apart in the multidose phase and were followed for 12 weeks (85 days). Assessments included adverse events, best-corrected visual acuity, low luminance visual acuity, vital signs, clinical laboratory evaluations, GA lesion area as measured by fundus autofluorescence, spectral-domain optical coherence tomography; and pharmacokinetic, immunogenicity and pharmacodynamic assessments.
All 15 participants completed the 12-week study. Here are some of the findings:
• There were no serious adverse events and no drug-related adverse events, and no choroidal neovascularization developed in either eye.
• Mean visual acuity and GA lesion area appeared stable through week 12 for all cohorts.
• Pharmacokinetic analyses indicated that NGM621 serum exposures appeared to be dose proportional, and no antidrug antibodies were identified at any of the evaluated time points.
Investigators wrote, in this small, open-label, 12-week Phase I study, NGM621 was safe and tolerable when administered intravitreally up to 15 mg.
SOURCE: Wykoff CC, Hershberger V, Eichenbaum D, et al. Inhibition of complement C3 in geographic atrophy with NGM621: Phase 1 dose-escalation study results. Am J Ophthalmol 2021; Sep 9. [Epub ahead of print].
GA Characteristics Using Fluorescence Lifetime Imaging Ophthalmoscopy
Researchers wrote that short foveal fluorescence lifetimes (fFLTs) in geographic atrophy are typically found in eyes with foveal sparing disease but may also occur in eyes without foveal sparing disease. They investigated whether short fFLTs could serve as a functional biomarker for disease progression in geographic atrophy.
Thirty-three eyes were followed over four to six years. Foveal sparing was assessed using fluorescence lifetime imaging ophthalmoscopy, optical coherence tomography, fundus autofluorescence and macular pigment optical density.
Here are some of the findings:
• Eyes with foveal sparing exhibited shorter fFLTs compared to eyes without foveal sparing.
• Short fFLTs (<600 ps) were measured in all eyes with foveal sparing and half of the eyes without foveal sparing.
• Eyes with foveal sparing showed a greater increase in fFLTs per year (+39/+30 ps [SSC/LSC]) in foveal sparing vs. +29/+22 ps [SSC/LSC] in non-foveal sparing).
• BCVA correlated significantly with fFLTs (p=0.018 and p=0.005 for SSC/LSC).
• MPOD measurements correlated significantly with fFLTs but not in all spectral channels (p=0.018 to 0.077).
Researchers determined that, in GA, shorter foveal fluorescence lifetimes were associated with foveal sparing and also were observed in eyes without foveal sparing. They added that longitudinal data suggested that shorter fFLT features in eyes with loss of foveal sparing represented an earlier stage of disease and may increase the risk of visual acuity loss.
SOURCE: Lincke JB, Dysli C, Jaggi D, et al. Longitudinal foveal fluorescence lifetime characteristics in geographic atrophy using fluorescence lifetime imaging ophthalmoscopy (FLIO). Retina 2021; Jul 17. [Epub ahead of print].
Clinical Features and Treatment Outcomes of Inflammatory CNV
Investigators considered the long-term clinical features and treatment outcomes of patients with inflammatory choroidal neovascularization treated with intravitreal anti-vascular endothelial growth factor, as part of a retrospective, interventional, consecutive case series.
They included 65 eyes of 65 patients with inflammatory CNV treated with anti-VEGF injections and followed up for at least 12 months. A retrospective chart review was conducted at a single tertiary referral center.
Study participants were followed for 60.6 ±42.8 (range: 16 to 160) months. Mean age was 33.4 ±10.8 years, and mean refractive error was -3.94 ±1.35 D in spherical equivalent. Final best-corrected visual acuity was 0.21 ±0.20 logMAR (around 20/32) after treatment. Patients were treated with bevacizumab (76.9 percent), ranibizumab (4.6 percent), aflibercept (3.1 percent) and drug combinations (15.4 percent). Here are some of the findings:
• Systemic corticosteroid or immunosuppressant use wasn’t correlated with visual outcome, required number of anti-VEGF injections or recurrence.
• Commonly occurring optical coherence tomography features included:
o ellipsoid zone disruption;
o choroidal hypertransmission;
o retinal pigment epithelium atrophy (RPEA) or absence;
o intraretinal hyperreflective foci (HRF);
o choroidal vessel engorgement;
o focal choroidal excavation; and
o irregular vascular loops (on OCT angiography).
• RPEA after treatment (β=0.238, p=0.036) and BCVA (β=0.267, p=0.029) showed significant correlation with final BCVA.
• Twenty-eight patients (43.1 percent) experienced recurrence; intraretinal HRF after treatment was the single risk factor for recurrence (OR, 2.712; p=0.031).
Investigators found that inflammatory CNV recurrence showed higher rates over time after anti-VEGF treatment than previously reported, even though the overall visual outcome was good. They also reported that baseline BCVA and RPEA after treatment were significant predictors of visual outcome, and that intraretinal HRF after anti-VEGF treatment may indicate a heightened risk of recurrence.
SOURCE: Kim M, Lee J, Park YG, et al. Long-term analysis of clinical features and treatment outcomes of inflammatory choroidal neovascularization. Am J Ophthalmol 2021; Jul 20. [Epub ahead of print].
Dexamethasone Intravitreal Implant in Treatment-naïve DME
Researchers evaluated the effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX; Ozurdex) monotherapy in the patient subgroup of the AUSSIEDEX study with treatment-naïve diabetic macular edema.
The open-label, prospective, Phase IV, real-world study included pseudophakic eyes and phakic eyes scheduled for cataract surgery that were treatment-naïve or non-responsive to anti-vascular endothelial growth factors. No eyes were excluded based on baseline best-corrected visual acuity or central subfield retinal thickness. After the initial DEX injection at the baseline visit, reinjection was permitted at ≥16-week intervals. Week-16 and week-52 visits were mandatory. Primary endpoints were changes in mean BCVA and CRT from baseline to 52 weeks.
Here are some of the findings:
• Of 200 eyes enrolled in the AUSSIEDEX study, 57 were treatment-naïve.
• Baseline mean BCVA was 58.8 letters, and baseline mean CRT was 418.6 µm; changes in mean BCVA and CRT from baseline to 52 weeks in this subgroup were 3.4 letters (p=0.042) and -89.6 µm (p<0.001), respectively, with a mean 2.5 injections.
• The change in mean CRT from baseline was -55.8 µm at week 16 (p<0.001).
• The most common adverse event was increased intraocular pressure, with 20 percent of eyes requiring IOP-lowering medication.
• One patient was discontinued due to increased IOP.
• No eyes required filtration surgery.
• No serious, treatment-related ocular adverse events were reported.
The researchers wrote that DEX significantly improved CRT and BCVA at 52 weeks in treatment-naïve eyes in this real-world study of DEX monotherapy for DME—without new safety concerns—supporting DEX use in treatment-naïve DME.
SOURCE: Fraser-Bell S, Kang HK, Mitchell P, et al. Dexamethasone intravitreal implant in treatment-naïve diabetic macular oedema: findings from the prospective, multicentre, AUSSIEDEX study. Br J Ophthalmol 2021; Aug 25. [Epub ahead of print].
Intravitreal Pharmacotherapies for DME: A Report by the American Academy of Ophthalmology
Researchers reviewed the evidence on the safety and efficacy of current anti-vascular endothelial growth factor and intravitreal corticosteroid pharmacotherapies for the treatment of diabetic macular edema.
Literature searches were last conducted on May 13, 2020, in the PubMed database with no date restrictions and limited to articles published in English. The combined searches yielded 230 citations, of which 108 were reviewed in full text. Of these, 31 were deemed appropriate for inclusion in this assessment and were assigned a level of evidence rating by the panel methodologist.
Here are some of the findings:
• Only 21 articles with level I evidence were included in this assessment.
• Seventeen articles provided level I evidence for one or more anti-VEGF pharmacotherapies, including ranibizumab (14), aflibercept (5), and bevacizumab (2) alone or in combination with other treatments for DME.
• Level I evidence was identified in seven articles on intravitreal corticosteroid therapy for treatment of DME: triamcinolone (1); dexamethasone (4); and fluocinolone acetonide (2).
The authors wrote that review of the available literature indicated that intravitreal injections of anti-VEGF agents and corticosteroids were effective treatments for DME. They added that elevated intraocular pressure and cataract progression were important potential complications of corticosteroid therapy. The authors also wrote that further evidence is required to assess the comparative efficacy of these therapies. They concluded that, given the limited high-quality comparative efficacy data, choice of therapy must be individualized for each patient, and broad therapeutic access for patients is critical to maximize outcomes.
SOURCE: Ehlers JP, Yeh S, Maguire MG, et al. Intravitreal pharmacotherapies for diabetic macular edema: A report by the American Academy of Ophthalmology. Ophthalmology 2021; Aug 23. [Epub ahead of print].
Contrast Sensitivity & QOL Following Intravitreal Ranibizumab Injection for CRVO
Scientists evaluated the relationship between contrast sensitivity and vision-related quality of life (VR-QOL) in patients with central retinal vein occlusion following ranibizumab intravitreal injection.
They looked at the relationship between CS, VR-QOL and optical coherence tomography findings in patients with cystoid macular edema secondary to central retinal vein occlusion (CRVO-CMO) following intravitreal injection of ranibizumab.
This multicenter, open-label, single-arm, prospective study included 23 patients with CRVO-CMO who were followed up for 12 months after treatment. Best-corrected visual acuity, letter contrast sensitivity (LCS) and OCT images were obtained every month. For VR-QOL assessment, the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) was administered to patients before treatment, and at three, six and 12 months following treatment.
Here are some of the findings:
• The LCS and VFQ-25 composite score improved significantly from baseline to 12 months following treatment.
• Multiple regression analysis revealed the LCS of the affected eye and BCVA of the fellow eye were related to the VFQ-25 composite score following treatment.
• The LCS improvement showed a significant correlation with the improvement in the VFQ-25 composite score, whereas BCVA improvement wasn’t correlated with improvement in the VFQ-25 composite score.
• Stepwise multiple regression analyses revealed, at the time of macular edema resolution, the distance between the external limiting membrane and retinal pigment epithelium (ELM-RPE) and average ganglion cell-inner plexiform layer (GCIPL) thickness were associated with LCS.
Scientists determined that CS had a stronger association with VR-QOL than with BCVA in patients with CRVO-CMO. They added, with the resolution of macular edema, CS was associated with ELM-RPE thickness and average GCIPL thickness.
SOURCE: Murakami T, Okamoto F, Sugiura Y, et al. Contrast sensitivity and quality of life following intravitreal ranibizumab injection for central retinal vein occlusion. Br J Ophthalmol 2021; Aug 27. [Epub ahead of print].
Apellis Announces Positive Topline Results from Phase III DERBY & OAKS
Apellis Pharmaceuticals reported topline results from the Phase III DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy secondary to age-related macular degeneration. The company says that monthly and bi-monthly treatment with pegcetacoplan met the primary endpoint in OAKS, significantly reducing GA lesion growth by 22 percent and 16 percent, respectively, compared to pooled sham at 12 months.
DERBY didn’t meet the primary endpoint, showing a reduction in GA lesion growth of 12 percent and 11 percent with monthly and every-other-month treatment, respectively, compared to pooled sham at 12 months. In a prespecified analysis of the combined DERBY and OAKS studies, monthly and every-other-month treatment with pegcetacoplan reduced GA lesion growth by 17 percent (p<0.0001) and 14 percent (p=0.0012), respectively, compared to pooled sham at 12 months, Apellis says. Based on these results, the company plans to submit a New Drug Application for pegcetacoplan for GA to the FDA in the first half of 2022. Read more.
Source: Apellis Pharmaceuticals, September 2021
Regeneron Announces Topline Phase II Data
Regeneron Pharmaceuticals announced that an ongoing Phase II proof-of-concept trial evaluating an investigational 8 mg dose of aflibercept met its primary safety endpoint, with no new safety signals observed compared to the currently-approved 2 mg dose of Eylea (aflibercept) Injection in patients with wet age-related macular degeneration. In this small trial involving 106 patients, a higher proportion of patients in the aflibercept 8 mg group had no retinal fluid (43.4 percent, n=23/53) compared to patients treated with Eylea 2 mg (26.4 percent, n=14/53) (p=0.067) at week 16, the primary efficacy endpoint. At this timepoint patients had received three initial doses (administered at weeks 0, 4 and 8), after which dosing was extended. Read more.
Source: Regeneron, August 2021
AbbVie and Regenxbio Announce Eye Care Collaboration
AbbVie and Regenxbio will partner to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases. RGX-314 is being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials using in-office suprachoroidal delivery. Read more.
SOURCE: AbbVie and Regenxbio, September 2021
Novartis Announces Results from Phase III Trials of Beovu
Novartis announced results from two Phase III clinical trials assessing Beovu (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema. The company says that results from year two (week 100) of KITE demonstrated that most patients who completed an initial 12-week cycle following a loading phase were maintained on a 12- or 16-week dosing interval through the end of the study. As previously reported, KITE met its primary endpoint of non-inferiority to aflibercept in best-corrected visual acuity from baseline at year one (week 52). Another Beovu study, KINGFISHER, met its primary endpoint of non-inferiority to aflibercept in change in BCVA from baseline at year one (week 52) when dosed every four weeks. Both trials demonstrated an overall well-tolerated safety profile, the company says. Read more.
SOURCE: Novartis, August 2021
MeiraGTx Announces Data Demonstrating Reversal of Disease Progression in X-Linked Retinitis Pigmentosaa
MeiraGTx announced new data from subjects treated in the Phase I/II dose-escalation phase of study MGT009 indicated that AAV5-RPGR, an investigational gene therapy in development for the treatment of X-linked retinitis pigmentosa, reversed the course of disease progression when retinal function was assessed 12 months when compared with retinal function in the same subjects up to 48 months prior to treatment. The data were presented at the EURETINA 2021 Virtual Meeting. Read more.
SOURCE: MeiraGTx, September 2021
GenSight Announces Publication Analyzing Visual Parameters of ND4-LHON Subjects before LUMEVOQ treatment in Phase III Trials
GenSight Biologics announced that Journal of Neuro-Ophthalmology published a paper on a cross-sectional analysis of the baseline (pre-treatment) characteristics of the ND4-LHON subjects enrolled in the RESCUE and REVERSE Phase III trials of LUMEVOQ. The paper, published in the September issue, confirmed drastic loss of visual function and anatomy in the year after onset of vision loss due to Leber’s hereditary optic neuropathy caused by the G11778A mutation in the ND4 gene. Read more.
SOURCE: GenSight Biologics, September 2021
Luneau Introduces Visionix VX650
Luneau Technology introduced the Visionix VX650 ocular measuring device with retinal screening, which the company says can deliver a comprehensive eye exam in minutes, and provide screening data on anterior and posterior eye segments to identify and detect the early signs of cataracts, glaucoma, retinal and corneal pathologies. The device also offers detection and management of keratoconus. A 45-degree fundus camera along with topography, wavefront aberrometry, tomography and retinal screening are all built in. Read more.
SOURCE: Luneau Technology, September 2021
Aequus and reVision to Collaborate
Aequus Pharmaceuticals and reVision Therapeutics say they will collaborate on the development of a therapy for Stargardt’s disease. Read more.
SOURCE: Aequus Pharmaceuticals and reVision Therapeutics, August 2021
Retina ‘Hardwired’ to Predict Path of Moving Objects
Neural circuits in the primate retina can generate the information needed to predict the path of a moving object before visual signals even leave the eye, UW Medicine researchers demonstrate in a new paper. The ability to predict where moving objects will go is so important for survival that it’s likely hardwired into all sighted animals, researchers found. The findings were published in Neuroscience. Read more.
SOURCE: National Eye Institute, August 2021
FDA Approves First Ophthalmic Biosimilar
In mid-September, U.S. Food and Drug Administration announced the approval of the first ophthalmology biosimilar to ranibizumab (Lucentis, Genentech/Roche), the anti-vascular endothelial growth factor agent Byooviz. South-Korea based Samsung Bioepis and U.S. partner Biogen developed Byooviz, or SB11, which has been approved to treat vascular (wet) age-related macular degeneration, macular edema, and myopic choroidal neovascularization, all indications for Lucentis, first FDA-approved in 2006. Read more.
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