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.
Monitoring Tests of Fellow Eyes in Unilateral nAMD: EDNA Study
Researchers compared the diagnostic accuracy of routinely used tests of visual function and retinal morphology with fundus fluorescein angiography (FFA) to detect onset of active macular neovascularization in unaffected fellow eyes of patients with unilateral neovascular age-related macular degeneration.
A prospective diagnostic accuracy cohort study conducted in 24 eye clinics in the U.K. over three years included older adults (>50y) with recently diagnosed unilateral nAMD with a fellow (study) eye free of nAMD.
Index tests included self-reported vision, Amsler grid, clinic-measured visual acuity, fundus assessment and spectral-domain optical coherence tomography. FFA was used as a reference standard. Main outcome measures included sensitivity and specificity of the five index tests.
Of 552 participants monitored for up to three years, 145 (26.3 percent) developed active nAMD in the study eye, of whom 120 had an FFA at detection and constituted the primary analysis cohort. Here are some of the findings:
• Index test positives at nAMD detection in those confirmed by FFA had:
o self-reported vision rated as “much worse”;
o distortion on Amsler: 33;
o 10-letter decrease in acuity from baseline of 36;
o fundus exam results: 64; and
o OCT findings: 110.
• Index test sensitivities were:
o self-reported vision: 4.2 (CI, 1.6 to 9.8);
o Amsler: 33.7 (CI, 25.1 to 43.5);
o visual acuity: 30 (CI, 22.5 to 38.7);
o fundus exam: 53.8 (CI, 44.8 to 62.5); and
o OCT: 91.7 (CI, 85.2 to 95.6).
• All five index test specificities were high at:
o self-reported vision: 97 (94.6 to 98.5);
o Amsler: 81.4 (CI, 76.4 to 85.5);
o visual acuity: 66.3 (CI, 61 to 71.1);
o fundus exam: 97.6 (CI, 95.3, 98.9); and
o OCT: 87.8 (83.8, 90.9).
• The combination of OCT with one other index test—which was a secondary outcome measure—increased sensitivity marginally and decreased specificity for all combinations except the fundus exam.
Researchers found that in tests of self-reported change in vision, with unmasking of new distortion, measurements of acuity and fundus checks to diagnose active nAMD performed poorly compared with OCT. They wrote their findings support a change to guidelines in clinical practice to monitor for onset of nAMD.
SOURCE: Sivaprasad S, Banister K, Azuara-Blanco A, et al. Diagnostic accuracy of monitoring tests of fellow eyes in patients with unilateral neovascular age related macular degeneration (EDNA study). Ophthalmol 2021; Jul 27. [Epub ahead of print].
Development of Intraretinal Fluid in nAMD During Anti-VEGF Treatment
Researchers aimed to identify the risk factors of intraretinal fluid development during anti-vascular endothelial growth factor treatment for neovascular age-related macular degeneration, as part of a retrospective cohort study.
A total of 425 treatment-naïve patients with neovascular AMD who completed 24 months of follow-up were enrolled. All patients were treated with an initial series of three monthly loading doses of anti-VEGF injections, followed by further injections as required. Baseline characteristics were evaluated using multivariate modeling to determine the potential risk factors for IRF development.
Here are some of the findings:
• IRF occurred in 40.2 percent (171/425 eyes) of all participants during the maintenance phase after the loading injections.
• The development of IRF during follow-up negatively affected visual outcomes, regardless of the presence of IRF at baseline.
• Multivariate analysis showed that larger areas of choroidal neovascularization (OR, 1.360; p<0.001), the presence of IRF at baseline (OR, 5.469; p<0.001) and the presence of fibrovascular pigment epithelial detachment (OR, 2.043; p=0.022) were associated with an increased risk of IRF during follow-up.
• Type 1 (OR, 2.005; p<0.001) and type 2 macular neovascularization (OR, 2.643; p<0.001) were also associated with a higher risk of IRF than aneurysmal type 1 MNV/polypoidal choroidal vasculopathy.
Researchers reported the development of IRF during anti-VEGF treatment for neovascular AMD had additional negative effects on visual outcomes, regardless of the presence of IRF at baseline. They found that baseline risk factors—including CNV size, presence of IRF at baseline, presence of fibrovascular PED and MNV subtype—may influence the development of IRF during anti-VEGF treatment.
SOURCE: Cho HJ, Yoon W, Yoon J, et al. Development of intraretinal fluid in neovascular age-related macular degeneration during anti-vascular endothelial growth factor treatment. Am J Ophthalmol 2021; Jul 30. [Epub ahead of print].
Efficacy & Safety of Brolucizumab vs. Aflibercept in PCV Eyes in HAWK
Researchers compared the efficacy and safety of brolucizumab (Novartis) vs. aflibercept (Regeneron) in eyes with polypoidal choroidal vasculopathy over 96 weeks in the Novartis-sponsored HAWK study, a global, two-year, randomized, double-masked, multicenter Phase III trial in participants with neovascular age-related macular degeneration.
Of the participants (who were Japanese) with PCV, 39 received brolucizumab 6 mg and 30 received aflibercept 2 mg. After three monthly loading doses, brolucizumab-treated eyes received an injection every 12 weeks (q12w) but were adjusted to q8w if disease activity was detected. Aflibercept-treated eyes received fixed q8w dosing. Mean change in best-corrected visual acuity, the proportion of participants on q12w, retinal thickness, retinal fluid changes and safety were assessed to week 96.
Here are some of the findings:
• Mean change in BCVA (early treatment diabetic retinopathy study [ETDRS] letters) from baseline to week 48/week 96 was +10.4/+11.4 for brolucizumab and +11.6/+11.1 for aflibercept.
• For brolucizumab-treated eyes, the probability of only q12w dosing after loading was 76 percent through week 48, and 68 percent through week 96.
• Brolucizumab exhibited an overall well-tolerated safety profile despite a higher rate of intraocular inflammation compared with aflibercept.
Researchers found that, in Japanese eyes with PCV, brolucizumab q12w/q8w monotherapy resulted in consistent BCVA gains comparable to q8w aflibercept dosing. Anatomical outcomes favored brolucizumab over aflibercept, with 76 percent of brolucizumab participants maintained on q12w dosing after loading to week 48.
SOURCE: Ogura Y, Jaffe GJ, Cheung CMG, et al. Efficacy and safety of brolucizumab versus aflibercept in eyes with polypoidal choroidal vasculopathy in Japanese participants of HAWK. Br J Ophthalmol 2021; Jul 22. [Epub ahead of print].
Five-year Outcomes in Patients Undergoing Treatment for nAMD
Scientists assessed the impact of disease activity on clinical outcomes in a “real-world” cohort with neovascular age related macular degeneration over five years.
Data were obtained from the prospectively-defined Fight Retinal Blindness! registry. Eyes were divided into tertiles based on the proportion of visits in which choroidal neovascular lesion activity was shifting (low, moderate and high) until five years.
Data from 2,109 eyes were included. Here were some of the findings:
• The adjusted mean VA change was:
o -0.5 letters (CI, -1.8 to 1.1) in the high activity group;
o 1.8 letters (CI, 0.2 to 3.4) in the moderate activity group; and
o -2.5 letters (CI, -4.2 to -1.3) in the high activity group (p<0.001).
• Eyes in the low activity group were more likely to develop macular atrophy (56 percent in the low activity group, 47 percent in the moderate activity group and 26 percent in the high activity group [p<0.001]) but less likely to develop subretinal fibrosis (27 percent in the low activity group, 35 percent in the moderate activity group and 42 percent in the high activity group [p<0.001]).
Scientists concluded that eyes with higher and lower levels of disease activity had poorer outcomes than eyes with moderate activity over five years, apparently due to the development of subretinal fibrosis or macular atrophy.
SOURCE: Chong Teo KY, Nguyen V, Gemmy Cheung CM, et al. The impact of disease activity on 5 year outcomes in patients undergoing treatment for neovascular age related macular degeneration. Retina 2021; Jul 16. [Epub ahead of print].
Peripheral Monocyte Count and AMD: The Tongren Health Care Study
Scientists assessed potential associations between the prevalence of age-related macular degeneration and systemic parameters in a Chinese population, as part of a cross-sectional study.
The Tongren Health Care Study included individuals attending regular health care check-up examinations in the Beijing Tongren Hospital from 2017 to 2019. Detailed medical examinations and ophthalmic examinations were applied, including fundus photography. AMD was evaluated according to the Beckman Initiative guidelines.
The study included 7,719 participants (mean age: 60.5 ±8.1 years; range: 50 to 97 years). Here are some of the findings:
• The prevalence of any, early, intermediate or late AMD was (out of the 7,719 patients):
o 1,607 any (20.8 percent; CI, 20.1 percent, 21.9 percent);
o 832 early (10.8 percent; CI, 10.1 percent, 11.5 percent);
o 733 intermediate (9.5 percent; CI: 8.9 percent, 10.2 percent); and
o 42 late (0.50 percent; CI, 0.40 percent, 0.70 percent).
• In multivariate analysis, the prevalence of any AMD increased with higher blood monocyte count (odds ratio [OR]:3.49; CI: 2.26, 5.38; p<0.001), after adjusting for:
o older age (OR: 1.06; CI, 1.05, 1.07; p<0.001);
o higher serum concentration of calcium (OR: 2.52; CI, 1.32, 4.84; p=0.005);
o high-density lipoproteins (OR: 1.39; CI, 1.19, 1.61; p<0.001); and
o lower lipoprotein a (OR: 0.99; CI, 0.98, 0.99; p=0.02).
• Similar findings were obtained for the prevalence of intermediate and late AMD combined.
• The association between higher monocyte count and higher AMD prevalence showed the highest odds ratio for the age group of 50 to 59 years (any AMD: OR: 4.35, p<0.001; intermediate and late AMD: OR: 6.14, p<0.001).
• Individuals with a monocyte count of ≥0.5 × 109/L compared to participants with a monocyte of 0.1-0.4 × 109/L had a 1.45-fold increased risk for any AMD (OR: 1.45; CI, 1.27, 1.64; p<0.001) and 1.58-fold increase risk for intermediate/late AMD (OR: 1.58; CI, 1.33, 1.87; p<0.001).
Scientists determined that a higher prevalence of early AMD, intermediate AMD, late AMD and any AMD was associated with a higher peripheral monocyte count. They wrote that the observation, similar to previous findings, suggests monocytes play a role in the pathogenesis of AMD.
SOURCE: Xue CC, Cui J, Gao LQ, et al. Peripheral monocyte count and age-related macular degeneration. The Tongren Health Care Study. Am J Ophthalmol 2021;227:7:143-53.
Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase IIa, Randomized, Clinical Trial
Researchers evaluated the safety and efficacy of 1.0 mg risuteganib in subjects with nonexudative age-related macular degeneration, as part of a Phase IIa, prospective, double-masked, sham-controlled study. Eyes with nonexudative (dry) AMD and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity between 20/40 and 20/200 were included. Subjects were randomized to intravitreal 1.0 mg risuteganib or sham injection. At week 16, subjects in the risuteganib group received a second 1.0-mg dose and the sham group crossed over to receive a dose of 1.0 mg risuteganib and were evaluated at week 28. The primary endpoint was proportion of subjects with eight or more letters ETDRS of BCVA gain from baseline to week 28 in the risuteganib group vs. baseline to week 12 for the sham group. BCVA was tested and subjects were observed for adverse events (AEs) every four weeks until completion of the study at 32 weeks.
Forty-five subjects (risuteganib, n=29; sham, n=16) were enrolled in the study, of whom 39 (risuteganib, n=25; sham, n=14) completed the study and were included in the per protocol efficacy analysis. At baseline, the mean age was 78.8 and 75.9 years, and the mean BCVA was 67.1 and 64.4 letters in the sham and risuteganib groups, respectively. Here are some of the findings:
• The primary endpoint was met by 48 percent of the risuteganib group at week 28 and 7 percent of the sham group at week 12 (p=0.013).
• Of the risuteganib subjects, 20 percent gained 15 letters or more at week 28, whereas no patients in the sham group at week 12 achieved this visual acuity gain.
• The only ocular treatment-related treatment-emergent AE was vitreous floaters, which spontaneously recovered without sequelae. No drug-related serious AEs were reported.
Researchers wrote that risuteganib demonstrated significant BCVA improvement in patients with non-exudative AMD. They added that no drug-related adverse events were seen during a 32-week observation period.
SOURCE: Boyer DS, Gonzalez VH, Kunimoto DY, et al. Safety and efficacy of intravitreal risuteganib for non-exudative AMD: A multicenter, phase 2a, randomized, clinical trial. Ophthalmic Surg Lasers Imaging Retina 2021 Jun;52(6):327-35.
Cluster Analysis & Genotype-phenotype Assessment of GA in AMD: AREDS2 Report 25
Investigators explored whether phenotypes in geographic atrophy secondary to age-related macular degeneration can be separable into two or more partially distinct subtypes, and if these have different genetic associations. The discovery of distinct GA subtypes associated with different genetic factors could indicate the need for customized therapeutic approaches.
Participants underwent cluster analysis within a controlled clinical trial, followed by assessment of phenotype-genotype associations. They included AREDS2 participants with incident GA during study follow-up, i.e., 598 eyes of 598 participants with a median age of 75.7 years).
Phenotypic features from reading center grading of fundus photographs were subjected to cluster analysis by k-means and hierarchical methods in cross-sectional analyses (using 15 phenotypic features assessed principally at GA emergence) and longitudinal analyses (using 14 phenotypic features). In pre-specified hypothesis tests, identified clusters were compared by four pathway-based genetic risk scores (complement, extracellular matrix, lipid and ARMS2). The analyses then were repeated in reverse, i.e., clustering by genotype and comparing by phenotype.
Main outcome measures included characteristics and quality of cluster solutions assessed by Calinski-Harabasz scores, unexplained variance and consistency, and genotype-phenotype associations assessed by T test.
Here are some of the findings:
• In cross-sectional phenotypic analyses, k-means identified two clusters (labeled A, B), while hierarchical clustering identified four (C-F); A-E membership differed principally by GA configuration but in relatively few other ways.
• In longitudinal phenotypic analyses, k-means identified two clusters (G, H), which differed principally by smoking status but in relatively few other ways.
• The three sets of cluster divisions weren’t similar to each other (r ≤ 0.20). Despite adequate power, pairwise cluster comparison by the four genetic risk scores demonstrated no significant differences (p>0.05 for all).
• In clustering by genotype, k-means identified two clusters (I/J).
• These differed principally at ARMS2, but no significant genotype-phenotype associations were observed (p>0.05 for all).
Researchers wrote that phenotypic clustering resulted in GA subtypes defined principally by GA configuration in cross-sectional analyses, but these weren’t replicated in longitudinal analyses. These negative findings, together with the absence of significant phenotype-genotype associations, indicated that GA phenotypes may vary continuously across a spectrum, rather than consisting of distinct subtypes that arise from separate genetic etiologies.
SOURCE: Keenan TDL, Oden NL, Agrón E, et al.; AREDS2 Research Group. Cluster analysis and genotype-phenotype assessment of geographic atrophy in age-related macular degeneration: AREDS2 Report 25. Ophthalmol Retina 2021; Jul 26. [Epub ahead of print].
Diagnostic Accuracy of OCTA in Detection of nAMD
This work was a systematic review and meta-analysis to evaluate the diagnostic accuracy of optical coherence tomography angiography in the identification of choroidal neovascularization due to age-related macular degeneration compared with fluorescein angiography.
A systematic search of the literature was carried out on Medline, EMBASE, Web of Science, Cochrane Library and Center for Reviews and Dissemination. Researchers selected studies comparing OCTA with FA for the diagnosis of choroidal neovascularization due to AMD that included data on the diagnostic validity of the test or the data necessary for its calculation.
Investigators used the QUADAS-2 tool to assess the risk of bias in selected studies. They performed a quantitative analysis of the results using meta-analysis. Seven primary studies were included. The quality of the evidence was considered to be reliable.
The total population included in the meta-analysis included 553 eyes. Here are some of the findings:
• The cumulative sensitivity was 85.9 percent (CI, 81.9 to 89.3 percent) and cumulative specificity was 89 percent (CI, 83.5 to 93.2 percent).
• The cumulative positive likelihood ratio was 8.36 (CI, 3.05 to 22.890); and the cumulative negative likelihood ratio was 0.15 (CI, 0.09 to 0.24); with a cumulative diagnostic odds ratio of 67.21 (CI, 22.58 to 200.05).
Investigators wrote that the evidence obtained didn’t demonstrate the superiority of OCTA over fluorescein angiography. They suggested OCTA’s use as a support technique could improve patient flow and reduce the number of fluorescein angiographies.
SOURCE: Maesa JM, Baños-Álvarez E, Rosario-Lozano M-P, et al. Diagnostic accuracy of optical coherence tomography angiography in the detection of neovasculature in age-related macular degeneration: A meta-analysis. Acta Ophthalmol 2021; Jul 26 [Epub ahead of print].
OCTA Findings of Classic CNV in PCV
Investigators evaluated the flow signals in subretinal hyperreflective material (SHRM) that represents classic choroidal neovascularization on fluorescein angiography in eyes with polypoidal choroidal vasculopathy (PCV).
They retrospectively reviewed 20 eyes with PCV that appeared to have classic CNV on FA, accompanied by SHRM on optical coherence tomography at the same location. Using OCT angiography, investigators analyzed intrinsic flow signals in the SHRM (cross-sectional en face B-scans). They evaluated the possible association between pretreatment OCTA findings and fibrotic scar formation after anti-vascular endothelial growth factor treatment.
Here are some of the findings:
• Six of 20 eyes (30 percent) showed vascular SHRM; the remaining 14 eyes (70 percent) showed avascular SHRM at the classic CNV site at baseline.
• The SHRM corresponded with polypoidal lesions seen on indocyanine green angiography in five of six eyes with vascular SHRM and in all 14 eyes with avascular SHRM.
• After anti-VEGF treatment, all six eyes with vascular SHRM left a fibrotic scar, while all 14 eyes with avascular SHRM showed no scar formation (p<0.001).
Investigators wrote that, using OCTA, they evaluated the flow signals in SHRM that represented classic CNV in eyes with PCV and successfully differentiated true type 2 macular neovascularization from pseudo classic CNV.
SOURCE: Izumi T, Koizumi H, Maruko I, et al. Optical coherence tomography angiography findings of classic choroidal neovascularization in polypoidal choroidal vasculopathy. Retina 2021; Jul 16. [Epub ahead of print].
Five-year Outcomes of Eyes Initially Enrolled in BEVORDEX
The BEVORDEX trial compared outcomes of eyes with diabetic macular edema randomized to receive either intravitreal dexamethasone (DEX-) implant or bevacizumab over two years. Investigators assessed long-term efficacy and safety outcomes five years from enrollment.
Patients received standard clinical care after they finished the study. Their files were reviewed for visual and anatomical outcomes, post-trial treatments and complications.
Three-year data for 82 percent of eyes, and five-year data for 59 percent of eyes were available in the BEVORDEX study. Here are some of the findings:
• Visual acuity gains at the end of trial were generally lost by both treatment groups at five years but the macular thickness didn’t change from the end of trial to five years.
• A similar proportion of eyes from each treatment group gained ≥10 letters at five years from enrollment in the BEVORDEX trial.
• Eyes that were initially randomized to the DEX-implant group had significantly fewer treatments but were more likely to develop proliferative diabetic retinopathy over the five-year period compared with eyes initially randomized to bevacizumab.
• The proportion of eyes that had cataract surgery by five years was similar between initial treatment groups.
Researchers wrote that eyes in the BEVORDEX trial had similar five-year rates of cataract surgery; however, more eyes converted to PDR in the group initially treated with the DEX-implant. They added that eyes initially treated for two years with either intravitreal DEX-implant or bevacizumab followed by standard of care had similar visual and anatomical outcomes at five years.
SOURCE: Cornish EE, Teo KY, Gillies MC, et al. Five-year outcomes of eyes initially enrolled in the 2-year BEVORDEX trial of bevacizumab or dexamethasone implants for diabetic macular oedema. British Journal of Ophthalmology 2021; Aug 2. [Epub ahead of print].
Self-supervised Feature Learning and Phenotyping for Assessing AMD Using Retinal Fundus Images
Researchers in a study on neural networks say that diseases such as age-related macular degeneration are classified based on human rubrics that are prone to bias. Supervised neural networks trained using human-generated labels require labor-intensive annotations and are restricted to the specific trained tasks, they add. In the study, the investigators trained a self-supervised deep learning network using unlabeled fundus images, enabling “data-driven feature classification of AMD severity and discovery of ocular phenotypes.”
They developed a self-supervised training pipeline to enable grading of AMD severity using fundus photographs from the Age-Related Eye Disease Study. A total of 100,848 human-graded fundus images from 4,757 AREDS participants between 55 and 80 years of age were included.
Researchers trained a deep neural network with self-supervised Non-Parametric Instance Discrimination (NPID) using AREDS fundus images without labels, then evaluated its performance in grading AMD severity using two-step, four-step and nine-step classification schemes using a supervised classifier. They compared balanced and unbalanced accuracies of NPID against supervised-trained networks and ophthalmologists, explored network behavior using hierarchical learning of image subsets and spherical k-means clustering of feature vectors, and searched for ocular features that can be identified without labels. Main outcome measures included accuracy and kappa statistics.
Here are some of the findings:
• NPID demonstrated versatility across different AMD classification schemes without retraining, and achieved balanced accuracies comparable to supervised-trained networks or human ophthalmologists in classifying advanced AMD (82 percent vs. 81 to 92 percent [for the networks], or 89 percent [for an ophthalmologist]), referable AMD (87 percent vs. 90 to 92 percent, or 96 percent), or on the four-step AMD severity scale (65 percent vs. 63 to 75 percent, or 67 percent), despite never directly using these labels during self-supervised feature learning.
• Drusen area drove network predictions on the four-step scale, while depigmentation and geographic atrophy areas correlated with advanced AMD classes.
• Self-supervised learning revealed grader-mislabeled images and susceptibility of some classes within the more granular nine-step AMD scale in addition to misclassification by both ophthalmologists and neural networks.
• Self-supervised learning enabled data-driven discovery of AMD features such as GA and other ocular phenotypes of the choroid (e.g., tessellated or blonde fundi), vitreous (e.g., asteroid hyalosis) and lens (e.g., nuclear cataracts) that weren’t predefined by human labels.
Researchers reported that self-supervised learning enabled AMD severity grading comparable to ophthalmologists and supervised networks, revealed biases of human-defined AMD classification systems; and allowed unbiased, data-driven discovery of AMD and non-AMD ocular phenotypes.
SOURCE: Yellapragada B, Hornauer S, Snyder K, Yu S, Yiu G. Self-supervised feature learning and phenotyping for assessing age-related macular degeneration using retinal fundus images. Ophthalmol Retina 2021; Jul 1. [Epub ahead of print].
FDA Accepts Application for Genentech’s Faricimab
Genentech announced the FDA accepted the company’s Biologics License Application, under Priority Review, for faricimab for the treatment of wet, or neovascular, age-related macular degeneration and diabetic macular edema. The FDA also accepted the company’s submission for diabetic retinopathy. Faricimab targets two distinct pathways—via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A)—that drive a number of retinal conditions that can cause vision loss. Read more.
Source: Genentech, July 2021
Efficacy & Safety Data from Phase III NORSE TWO Trial
Outlook Therapeutics announced “positive clinical and highly statistically significant topline results” from its pivotal Phase III NORSE TWO safety and efficacy trial evaluating ONS-5010 / Lytenava (bevacizumab) for treatment of neovascular age-related macular degeneration. The primary endpoint for the study was the proportion of patients who gain at least 15 letters in the best corrected visual acuity at 11 months. The trial compared ONS-5010 dosed monthly to Lucentis, which was dosed as one of the regimens listed in the Lucentis label (i.e., patients were treated monthly for the first three months followed by less frequent dosing; the PIER regimen). The key secondary endpoint for NORSE TWO was the mean change in the BCVA through 11 months. Topline data from NORSE TWO showed that ONS-5010 bevacizumab-vikg met primary and key secondary endpoint for efficacy with clinically impactful change observed for treated patients. Approval would make Lytenava the first FDA-approved formulation of bevacizumab for the eye. Read more.
SOURCE: Outlook Therapeutics, August 2021
Bioeq Submits Biologics License Application to FDA for Ranibizumab Biosimilar
Polpharma Biologics Group announced its joint venture company with Santo Holding, Bioeq, submitted a biologics license application to the FDA for a biosimilar candidate for ranibizumab (Lucentis). Read more.
SOURCE: Polpharma Biologics Group, August 2021
Ocular Therapeutix Announces First Patient Dosed in Phase I OTX-TKI Trial
Ocular Therapeutix dosed the first patient in the U.S. Phase I clinical trial of OTX-TKI (axitinib intravitreal implant) to treat wet AMD. The prospective, randomized, controlled multicenter trial is evaluating a single OTX-TKI implant containing a 600-µg dose of axitinib, compared with a 2-mg dose of aflibercept administered every eight weeks in subjects previously treated with anti-VEGF therapy.
In related news, Ocular Therapeutix and Regeneron have terminated their collaboration to bring a sustained-release aflibercept implant to market. Read more.
SOURCE: Ocular Therapeutix, July, August 2021
Iveric Bio Completes Patient Enrollment of GATHER2 Early
IVERIC bio announced the early completion of patient enrollment of GATHER2, the company’s second clinical trial of Zimura (avacincaptad pegol) in development for the treatment of geographic atrophy secondary to age-related macular degeneration. Read more.
SOURCE: IVERIC bio, July 2021
NGM Completes Enrollment in Phase II CATALINA Study
NGM Biopharmaceuticals completed enrollment in the Phase II CATALINA study, which is evaluating the safety and efficacy of intravitreal injections of NGM621 in patients with geographic atrophy secondary to age-related macular degeneration. Read more.
SOURCE: NGM Biopharmaceuticals, July 2021
Adverum Halts Development of ADVM-022 in DME After Additional Adverse Reactions
In an update on the ADVM-022 development program following a thorough review of data available from the INFINITY clinical trial in patients with diabetic macular edema and the OPTIC clinical trial in patients with wet age-related macular degeneration, Adverum Biotechnologies announced that data from the studies show marked differences in the safety profile between the two patient populations and between the low (2 x 1011 vg/eye) vs. high (6 x 1011 vg/eye) doses. Adverum says it no longer plans future development for DME after a dose-limiting toxicity was observed at the high dose (6 x 1011 vg/eye) in patients with DME. Read more.
Source: Adverum Biotechnologies, July 2021
Rezolute Initiates Dose Study of RZ402
Rezolute initiated dosing in a Phase Ib multiple-ascending dose study of RZ402, an investigational oral plasma kallikrein inhibitor for the treatment of diabetic macular edema. Rezolute also announced the appointment of Rajat Agrawal, MD, MS, as vice president, clinical development to lead the RZ402 clinical development program. Read more.
SOURCE: Rezolute, August 2021
Aldeyra Receives Orphan Drug Designation to Treat Retinitis Pigmentosa
Aldeyra Therapeutics announced the FDA granted orphan drug designation for ADX-2191 (methotrexate for intravitreal injection) for the treatment of retinitis pigmentosa. In addition to RP, the FDA granted orphan drug and fast track designation to ADX-2191 for the prevention of proliferative vitreoretinopathy. Read more.
SOURCE: Aldeyra Therapeutics, August 2021
EyePoint Announces New Executive Scientific Advisory Board
EyePoint Pharmaceuticals announced the formation of its Executive Scientific Advisory Board, chaired by Carl Regillo MD, FACS, chief of the Retina Service at Wills Eye Hospital. Other members of the SAB include: Drs. Sophie J. Bakri, MD, Mayo Clinic; Caroline R. Baumal, MD, Tufts Medical Center; David S. Boyer, MD, University of Southern California Keck School of Medicine; Glenn J. Jaffe, MD, Duke University; Rishi P. Singh, MD, Cleveland Clinic; and Charles C. Wykoff, MD, PhD, Retina Consultants of Texas. Read more.
SOURCE: EyePoint Pharmaceuticals, August 2021
Macular Pigment Screener on the Market
Azul Optics recently launched the MP-eye device, which the company says enables rapid screening of macular pigment levels, “the eye’s natural protection against violet-blue light and oxidative damage.” Vision Elements will distribute the MP-eye in the United States. Read more.
SOURCE: Azul Optics, August 2021
Harrow Health Acquires Patented Ophthalmic Surgical Drug Candidate from Sintetica
Harrow Health entered into an agreement with Sintetica to acquire the marketing and supply rights in the United States and Canada for AMP-100, an ophthalmic drug candidate for providing ocular surface anesthesia during ophthalmic interventions such as intravitreal injections. Read more.
SOURCE: Harrow Health, July 2021
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