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.
Long-term Anti-VEGF Treatment for nAMD: The LATAR Study
Researchers reported 10-year outcomes of eyes with neovascular age-related macular degeneration treated with vascular endothelial growth factor inhibitors as part of a 10-year, retrospective cohort study. Participants included 1,046 individuals who started treatment with anti-VEGF for nAMD.
Anti-VEGF-naïve eyes diagnosed with nAMD starting treatment between November 2006 and December 2009 were identified. Data collected included baseline demographics, visual acuity and the number of intravitreal injections. Baseline fundus fluorescein angiograms and optical coherence tomography images were graded for choroidal neovascularization type, and OCT images also were graded for central macular thickness and presence of fluid over 10 years.
Main outcome measures included the change in vision at 10 years, the proportion of eyes with either 20/40 vision or better, or 20/200 or worse; the percentage of eyes that were dry on OCT imaging and the number of injections.
From 1,046 eligible eyes, 10-year data were available for 293 eyes (28 percent), which were included in the analyses. Here were some of the findings:
• Eyes received 58.1 (SD: 23.6) injections during the 10 years.
• The mean central macular thickness decreased from 355.5 ±107.8 μm to 264.2 ±79.5 μm (p<0.001).
• The median baseline VA was 60 (IQR: 45 to 70) letters, which improved by 9 (IQR: 1 to 14) letters after the first year of treatment (p<0.001).
• Over the 10-year period, initial gains were lost over time, with a final VA change of +3 letters (IQR: 8 to 10 letters; p=0.162).
• The percentage of eyes with VA 20/40 or better increased from 29 percent at baseline to 35 percent at 10 years (p<0.001).
• The percentage of eyes at baseline with VA 20/200 or worse was 14 percent at baseline and 17 percent at 10 years.
Researchers wrote that, on average, eyes with nAMD maintained baseline VA when treated with VEGF inhibitors for 10 years. With ongoing regular treatment, a greater proportion of eyes achieved VA of 20/40 or better at 10 years than at presentation.
SOURCE: Spooner K, Fraser-Bell S, Hong T, et al. Long-term anti-VEGF treatment for neovascular age-related macular degeneration. The LATAR study report 1: Ten-year, real-world outcomes. Ophthalmol Retina 2020; Sept 29. [Epub ahead of print].
Ten-year Survival Trends of nAMD at First Presentation
Researchers described 10-year trends in visual outcomes, anatomical outcomes and treatment burden of individuals receiving anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration.
The retrospective cohort study included treatment-naïve, first-affected eyes with nAMD started on ranibizumab before January 1, 2009. The primary outcome was time to best-corrected visual acuity falling ≤35 ETDRS letters after initiating anti-VEGF therapy. Secondary outcomes included: time to BCVA reaching ≥70 letters; proportion of eyes with BCVA ≥70 and ≤35 letters in 10 years; mean trend of BCVA and central retinal thickness over 10 years; and mean number of injections.
Here were some of the findings:
• For the cohort of 103 patients, Kaplan-Meier analyses demonstrated median time to BCVA reaching ≤35 and ≥70 letters were:
o 37.8 (CI, 22.2 to 65.1) and 8.3 (CI, 4.8 to 20.9) months after commencing anti-VEGF therapy, respectively.
• At the final follow-up, BCVA was ≤35 letters and ≥70 letters:
o in 41.1 percent and 21 percent, respectively, in first-affected eyes;
o in 5.4 percent and 48.2 percent, respectively, in a patient’s better-seeing eye.
• Mean injection number was 37 ±24.2 per eye.
Researchers wrote that one in five individuals retained good vision (BCVA ≥70 ETDRS letters) in the first-affected eye at 10 years after starting anti-VEGF treatment, and one in two patients had good vision in their better-seeing eye. They added that early treatment of nAMD was associated with better visual outcomes and that the chronicity of nAMD disease and its management highlighted the importance of long-term visual prognosis.
SOURCE: Arpa C, Khalid H, Chandra S, et al. Ten-year survival trends of neovascular age-related macular degeneration at first presentation. Br J Ophthalmol 2020; Oct 3. [Epub ahead of print].
Principal Cause of Poor VA Following nAMD: AREDS2 Report Number 23
In AREDS2, the principal cause of visual acuity being worse than 20/200 two years after starting anti-VEGF therapy for neovascular age-related macular degeneration was central macular atrophy in 60 percent and central subretinal fibrosis in 40 percent of eyes. Researchers analyzed the principal cause for poor vision in eyes with best-corrected visual acuity ≤20/200 two years after documentation of nAMD, in a prospective cohort study of participants enrolled in a clinical trial of oral supplements who were receiving anti-VEGF therapy in routine clinical practice.
Participants included Age-Related Eye Disease Study 2 (AREDS2) participants, ages 50 to 85 years, whose eyes met AREDS2 inclusion criteria at baseline (no late AMD, BCVA ≥20/100 and no previous anti-VEGF injections) but who began anti-VEGF therapy for incident nAMD during follow-up and had data available at two years.
Participants underwent refracted BCVA testing, ophthalmoscopic exam and color fundus photography (CFP) at baseline and annual study visits. Self-reports of anti-VEGF injections were collected. Main outcome measures included the principal cause of BCVA ≤20/200 at two years and detection on CFP grading.
Here were some of the findings:
- Of the 594 eligible eyes, the number with BCVA ≤20/200 at two years was 56 eyes (9.4 percent).
- Mean BCVA was 14.9 letters (SD, 12.3; 20/500) vs. 70.1 letters (SD, 12.8; 20/40) in the other group.
- Of the 55 eyes with CFP available at two years, 33 (60 percent) were assessed from CFP grading to have central macular atrophy as the principal cause for poor vision.
- The remaining 22 eyes (40 percent) were assessed to have central subretinal fibrosis.
- The group with poor BCVA had:
- a higher proportion of non-white participants (8.9 vs 1.7 percent, p=0.006);
- lower BCVA two years earlier (mean 38; SD, 26.7; 20/160 vs. mean 71.8; SD, 11.9; 20/40; p<0.0001);
- higher proportion of patients with macular atrophy two years earlier (26.8 vs. 12.3 percent; p=0.003);
- higher proportion of patients with macular hemorrhage (25.5 vs. 13.2 percent; p=0.014); and
- fewer anti-VEGF injections (7.6 vs. 10.2; p=0.001).
Researchers wrote that BCVA data and CFP were obtained in a clinical trial environment but related to anti-VEGF therapy given in routine clinical practice. They reported that, at two years after starting anti-VEGF therapy, almost one in 10 eyes had BCVA at the level of legal blindness. Furthermore, they wrote, from CFP grading, the cause of poor vision appeared to be macular atrophy in 60 percent and subretinal fibrosis in 40 percent of eyes. Researchers concluded that the data may be useful in understanding the long-term limits to good vision in nAMD.
SOURCE: Okeagu CU, Agrón E, Vitale S, et al. Principal cause of poor visual acuity following neovascular age-related macular degeneration: AREDS2 Report Number 23. Ophthalmol Retina 2020; Oct 9. [Epub ahead of print].
Patient-reported Complications After Intravitreal Injection and Their Predictive Factors
Scientists wrote that the intravitreal injection (IVI) of pharmacological agents is the most commonly performed ocular procedure and is associated with a host of complications. The majority of IVI-related complications data is derived from randomized controlled clinical trials, which report a high adverse event rate, they noted. The nature of these protocol-driven trials limit their applicability to the diverse circumstances seen in routine clinical practice. The goal of this study was to determine the prevalence of patient-reported IVI-related complications, risk factors and the manner in which patients presented in a tertiary eye-care center.
The retrospective, IRB-approved review included 44,734 injections in 5,318 unique patients at the Cleveland Clinic Cole Eye Institute between 2012 and 2016. The main outcome measure was complication occurrence within 15 days of injection.
Between 2012 and 2016, a total of 44,734 injections were performed in 5,318 unique patients. Here were some of the findings:
- Overall, complication rates were low, representing 1.9 percent of all injections, with 1,031 unique complications in 685 (12.9 percent) patients.
- The most common minor complications, or those not requiring intervention, were irritation (n=312) and subconjunctival hemorrhage (n=284).
- The most common serious complications, or those requiring intervention, were corneal abrasion (n=46) and iritis (n=31).
- The majority of complications (66 percent) were adequately managed by a telephone/Epic electronic message encounter only.
- No injection protocol parameter, such as type of anesthesia, preparation or post-injection medication, increased the risk of a complication; however, patient sex, age, number of previous injections and provider strongly influenced the risk of patient-reported complications.
Scientists concluded that complication rates seen in routine clinical practice were low compared to clinical trial reporting. They added that providers should feel confident in the safety and administration of IVI during times when follow-up office visits and resources may be limited. Scientists advised that, when performing an IVI, factors such as a patient’s sex, age, number of previous injections and provider be taken into account to ensure the best possible outcomes.
SOURCE: Ramos MS, Xu LT, Singuri S, et al. Patient-reported complications after intravitreal injection and their predictive factors. Ophthalmol Retina 2020; Oct 11. [Epub ahead of print].
Dose-response Relationship Between Recurrent Intravitreal Injections and RNFL Thinning in Exudative AMD
Investigators aimed to determine if multiple intravitreal injections of vascular endothelial growth factor inhibitors for unilateral exudative age-related macular degeneration (eAMD) were associated with thinning of the retinal nerve fiber layer. They compared RNFL thickness measurements from the injected eye to that of the fellow eye with non-exudative AMD (neAMD), as part of a retrospective, cross-sectional study.
Participants included individuals undergoing anti-VEGF therapy for unilateral eAMD. Those receiving anti-VEGF therapy secondary to eAMD in one eye, with neAMD in the fellow eye were identified, while patients with a known diagnosis of glaucoma were excluded. Investigators performed and measured spectral-domain optical coherence tomography measurements of the peripapillary RNFL thickness from both eyes. They correlated differences in the RNFL thickness measurements between eyes with the number of injections and the duration of therapy. Main outcome measures included the correlation between the number of anti-VEGF injections and peripapillary RNFL thinning.
A total of 108 eyes of 54 individuals were evaluated. Here were some of the findings:
- The average peripapillary RNFL thickness measurements of the injected eye and fellow eye were 87.3 ±9.6 μm and 89 ±7.5 μm, respectively (p=0.055).
- The RNFL thickness difference (fellow eye minus injected eye) was significantly correlated with the number of injections (r=0.40, p=0.002) and months of injections (r=0.38, p=0.005).
- The relationship between the difference in the RNFL thickness and the number of injections had a non-linear dose-response relationship that become apparent after approximately 30 injections and 50 months of injections.
Investigators determined that the differences in RNFL thickness measurements between injected eyes and un-injected fellow eyes were largely within reported normal limits for interocular differences between healthy eyes. Nevertheless, they added, a dose-response relationship was found between RNFL thinning and number of injections among patients receiving a greater number of injections, suggesting that anti-VEGF injections may have a modest effect on the RNFL thickness after several years of therapy in eyes requiring more anti-VEGF injections. However, investigators continued, RNFL thinning may be secondary to active AMD disease progression in both eyes.
Source: Wang L, Swaminathan SS, Yang J, et al. Dose-response relationship between recurrent intravitreal injections and retinal nerve fiber layer thinning in exudative AMD. Ophthalmol Retina 2020; Oct 9. [Epub ahead of print].
Choriocapillaris Flow Deficit as a Risk Factor for AMD Progression
Investigators evaluated the association between choriocapillaris (CC) flow deficits and structural OCT biomarkers, and the progression of intermediate AMD (iAMD) to complete retinal pigment epithelial and outer retinal atrophy (cRORA).
They conducted a retrospective analysis of consecutive patients with iAMD with a minimum follow-up of 12 months. From logistic regression, investigators estimated:
• odds ratios of intraretinal hyperreflective foci (IRHF);
• hyporeflective drusen cores (hDC);
• subretinal drusenoid deposits (SDD);
• presence of drusen volume (DV) ≥0.03 mm within a central 3-mm circle, fellow eye with late stage of AMD;
• CC FD at baseline; and
• months of follow-up.
A total of 112 eyes with iAMD were included. Here were some of the findings:
• Eyes that progressed were significantly more likely to show IRHF, hDC and DV ≥0.03 mm.
• The CC flow deficit was significantly greater in eyes that developed cRORA.
• IRHF, hDC, DV ≥0.03 mm and higher CC flow deficit were significantly and independently associated with the development of cRORA.
Investigators concluded that CC flow deficits were significantly greater in iAMD eyes that progressed to cRORA, and remained an independent risk factor when structural OCT biomarkers were considered. They added that CC flow deficit may be useful for enhancing risk stratification and prognostication of individuals with iAMD.
SOURCE: Corvi F, Tiosano L, Corradetti G, et al. Choriocapillaris flow deficit as a risk factor for progression of age-related macular degeneration. Retina 2020 Sep 28. [Epub ahead of print].
Visit Adherence & VA Outcomes in DME: Analysis of DRCRnet Protocol T
Researchers quantified the association between visit adherence and visual acuity in diabetic macular edema, as part of a secondary analysis of the two-year DRCRnet Protocol T study of 656 individuals.
Individuals were required to have one visit every four weeks in the first year, then variable four-to-16-week interval visits in the second year. Visit adherence was measured as:
• number of missed visits;
• average (average days) and longest (maximum days) visit interval;
• average (average missed days) and longest (maximum missed days) unintended visit interval; and
• visit constancy (percentage of three-month periods with at least one visit).
Average and maximum missed days were categorized as on time (0 days), late (>0 to 60 days) and very late (>60 days).
The primary outcome was change in ETDRS VA between baseline and last attended visit using multivariate linear regression models controlling for: age; gender; race; ethnicity; treatment arm; baseline VA; hemoglobin A1c; insulin use; and number of lasers and injections.
Here were some of the findings:
SOURCE: Ramakrishnan MS, Yu Y, VanderBeek BL. Visit adherence and visual acuity outcomes in patients with diabetic macular edema: A secondary analysis of DRCRnet Protocol T. Graefes Arch Clin Exp Ophthalmol 2020 ; Sep 30. [Epub ahead of print].
• The mean number of missed visits was 1.7.
• A total of 616 (94 percent) individuals had 100 percent visit constancy.
• A total of 331 (51 percent) individuals were on time; 171 (26 percent) were late; and 154 (23 percent) very late in average missed days.
• Maximum missed days ranged from zero to 696 days.
• Adjusted, each missed visit was associated with 0.3-letter decrease (CI, 0.6 to 0.1, p=0.02); being very late in average and maximum missed days saw -4.2 letters (CI, -6.4, -2, p<0.001) and -4 letters (CI, -6.1 to -1.9, p<0.001), respectively, than on time.
• Those that averaged >4 days missed per attended visit saw 4.6 letters worse (CI, -7.3, -2, p<0.001).
Researchers concluded that visit adherence was associated with better visual acuity outcomes in DME patients.
Microvascular Impairments in Diabetic Patients Without Retinopathy
Researchers evaluated microvascular impairments with optical coherence tomography angiography in the eyes of diabetic patients with no diabetic retinopathy, as part of a systematic review and meta-analysis.
They searched PubMed and Embase databases to identify studies using OCTA to compare microvascular changes between diabetic eyes without clinical retinopathy and healthy controls. They extracted and analyzed data of interest using Review Manager V.5.3 and Stata V.14.0. They used weighted mean differences and their 95% confidence intervals to assess the strength of the association.
Forty-four cross-sectional studies involving 2,221 diabetic and 1,838 healthy eyes were included. Here were some of the findings:
- OCTA revealed that, compared with the healthy control group, the NDR group manifested enlarged areas and increased perimeters of the foveal avascular zone, with decreased perfusion density in the superficial and deep capillary plexus of the macula (except parafoveal PD of the inner retina and foveal PD) and reduced radial peripapillary capillary PD.
- In addition, subgroup analyses according to the type of diabetes mellitus indicated that most of those differences became nonsignificant (except parafoveal PD in the deep capillary plexus) in type 1 diabetes mellitus, while in type 2 diabetes mellitus, they remained statistically significant.
The researchers wrote that their findings suggested that retinal microvascular impairments might have occurred prior to clinically visible diabetic retinopathy and could be detected early by OCTA. However, they added, those manifestations could be inconsistent according to the types of diabetes mellitus.
SOURCE: Zhang B, Chou Y, Zhao X, et al. Early detection of microvascular impairments with optical coherence tomography angiography in diabetic patients without clinical retinopathy: A meta-analysis. Am J Ophthalmol 2020; Sept 31. [Epub ahead of print].
Detecting Morphologic DME Patterns Using OCT-based Deep Learning
Investigators developed a deep learning model to detect morphologic patterns of diabetic macular edema based on optical coherence tomography images.
In the training set, 12,365 OCT images were extracted from a public dataset and an ophthalmic center. A total of 656 OCT images was extracted from another ophthalmic center for external validation. The presence or absence of three OCT patterns of DME—including diffused retinal thickening (DRT), cystoid macular edema (CME) and serous retinal detachment (SRD)—were labeled with a one or a zero, respectively. A DL model was trained to detect three OCT patterns of DME. An occlusion test was applied for visualization of the DL model.
• Applying a five-fold cross-validation method in internal validation:
o the area under the receiver operating characteristic curve for detection of three OCT patterns (i.e., DRT, CME and SRD) was: 0.971, 0.974, and 0.994, respectively;
o accuracy was 93 percent, 95.1 percent and 98.8 percent, respectively; and
o sensitivity was 93.5 percent, 94.5 percent and 96.7 percent, respectively; and
o specificity was 92.3 percent, 95.6 percent and 99.3 percent, respectively.
• In external validation:
o the AUC was 0.970, 0.997 and 0.997, respectively;
o accuracy was 90.2 percent, 95.4 percent and 95.9 percent, respectively;
o sensitivity was 80.1 percent, 93.4 percent and 94.9 percent, respectively; and
o specificity was 97.6 percent, 97.2 percent and 96.5 percent, respectively.
• The occlusion test showed that the DL model could successfully identify the pathologic regions most critical for detection.
Investigators wrote that their DL model demonstrated high accuracy and transparency in detecting OCT patterns of DME. They say the results emphasized the potential of artificial intelligence to aid clinical decision-making processes for DME patients.
SOURCE: Wu Q, Zhang B, Hu Y, et al. Detection of morphologic patterns of diabetic macular edema using a deep learning approach based on optical coherence tomography images. Retina 2020; Oct 1. [Epub ahead of print].
Automated DR Detection with Two Retinal Imaging Devices Using AI
Scientists evaluated the diagnostic performance of an automated artificial intelligence-based diabetic retinopathy algorithm with two retinal imaging systems using two different technologies: a conventional flash fundus camera (TRC-NW8, Topcon) and a white LED confocal scanner (Eidon, Centervue). Two of the authors are consultants for Centervue.
On the same day, individuals underwent dilated color fundus photography using a conventional flash fundus camera and a fully automated white LED confocal scanner. All images were analyzed for DR severity both by retina specialists and the AI software EyeArt (Eyenuk), and graded as referable DR (RDR) or not RDR. Sensitivity, specificity and the area under the curve (AUC) were computed.
A series of 165 diabetic subjects (330 eyes) were enrolled. The automated algorithm achieved 90.8-percent sensitivity with 75.3-percent specificity on images acquired with the conventional fundus camera, and 94.1-percent sensitivity with 86.8-percent specificity on images obtained from the white LED confocal scanner. The difference between AUC was 0.0737 (p=0.0023).
Investigators concluded that the automated image analysis software was well-suited to work with different imaging technologies. They suggested that further evaluation in the context of screening campaigns would be needed.
SOURCE: Sarao V, Veritti D, Lanzetta P. Automated diabetic retinopathy detection with two different retinal imaging devices using artificial intelligence: A comparison study. Graefes Arch Clin Exp Ophthalmol 2020; Sep 16. [Epub ahead of print].
Quantitative Comparison of Four OCTA Devices in Healthy Eyes
A number of FDA-approved optical coherence tomography angiography devices are commercially available, each with unique algorithms and scanning protocols. Although several published studies have compared different combinations of OCTA devices, a lack of agreement exists on the consistency of measurements across OCTA devices. Therefore, scientists conducted a prospective, quantitative comparison of four available OCTA platforms.
Subjects were scanned on four devices: the Optovue RTVue-XR; Heidelberg Spectralis OCT2 module; Zeiss Plex Elite 9000 Swept-Source OCT; and Topcon DRI-OCT Triton Swept-Source OCT. Images (3 × 3 mm) were used for analysis. Foveal avascular zone (FAZ) area was separately and independently measured by two investigators. Scientists calculated fractal dimension (FD), superficial capillary plexus (SCP) and deep capillary plexus (DCP) vessel densities (VDs) from binarized images using Fiji image processing software. SCP and DCP VDs were further calculated after images were skeletonized. Scientists performed repeated measurements of analysis of variance (ANOVA), post hoc tests and interclass correlation coefficient (ICC) for statistical analysis.
Sixteen healthy eyes from 16 individuals were scanned on the four devices. Images of five eyes from the Triton device were excluded due to poor image quality; thus, the authors performed two sets of comparisons—one with and one without the Triton machine. The FAZ area showed no significant difference across devices, with an ICC of >95 percent. However, scientists found statistically significant differences for SCP and DCP VDs both before and after skeletonization (p<0.05). Fractal analysis revealed no significant difference for FD at the SCP; however, a statistically significant difference was found for FD at the DCP layer (p<0.05).
Scientists determined that FAZ measurements were consistent across all four devices, but there were significant differences in VD and FD measurements. They suggested that, for both clinical follow-up and research studies, FAZ area may be a useful parameter for OCTA image analysis when measurements are made on different devices, while VD and FD show significant variability when measured across devices.
SOURCE: Lu Y, Wang JC, Cui. Y, et al. A quantitative comparison of four optical coherence tomography angiography devices in healthy eyes. Graefes Arch Clin Exp Ophthalmol 2020; Sep 25. [Epub ahead of print].
Tarsius Shares Study Results of TRS01 for Uveitis
Tarsius Pharma announced that the GADOT 20/20 trial of its novel TRS01 drug for treating active anterior non-infectious uveitis demonstrated “significant improvement” in critical measures such as anterior chamber cells, pain reduction and increased visual acuity. The GADOT 20/20 trial was a dose-ranging, randomized, double-masked, controlled Phase I/II clinical trial that evaluated the safety and efficacy of TRS01 in 16 subjects with active non-infectious anterior uveitis in the United States. The study compared two different doses of TRS01. Read more.
SOURCE: Tarsius Pharma, October 2020
KODIAK TREATS FIRST PATIENTS IN THREE PHASE III STUDIES OF KSI-301
Kodiak Sciences announced the first patients were treated in the randomized, double-masked GLEAM, GLIMMER and BEACON Phase III studies of KSI-301, Kodiak's anti-VEGF antibody biopolymer conjugate, in treatment-naïve patients with diabetic macular edema (GLEAM and GLIMMER) and macular edema due to retinal vein occlusion (BEACON). U.S. recruitment in Kodiak's ongoing global DAZZLE Phase IIb/III study of KSI-301 in treatment-naïve wet age-related macular degeneration is now complete. Read more.
SOURCE: Kodiak Sciences, October 2020
FFB to Host Retinal Degeneration Webinar
The Foundation Fighting Blindness recently announced an upcoming webinar, Low Vision Resources and Rehabilitation for Retinal Degeneration Patients: A Webinar to Discuss Critical Needs and Opportunities. The organization says this free November 11 event for eye-care professionals will convene industry experts to discuss the latest in low-vision resources and rehabilitation as well as gaps in low-vision care. Register here.
Source: Foundation Fighting Blindness, October 2020
UNITY ANNOUNCES FIRST PATIENT DOSED IN PHASE I STUDY OF UBX1325 IN DME
Unity Biotechnology announced that the first patient was dosed in a Phase I study of UBX1325 in individuals with diabetic macular edema. The first-in-human, open-label, single-ascending dose study is designed to evaluate the safety, tolerability and pharmacokinetics of UBX1325 in individuals with advanced DME. The company anticipates initiating a proof of concept study in the first half of 2021. Read more.
SOURCE: UNITY Biotechnology, October 2020
SECOND SIGHT RESUMES ORION STUDY
Second Sight Medical Products’ Early Feasibility Study of the Orion Visual Cortical Prosthesis System at UCLA Medical Center has resumed. The study was paused for in-person visits following guidelines for clinical trials in March due to COVID-19. Orion is intended to provide useful artificial vision to individuals who are blind due to a range of causes, the company says. It converts images captured by a miniature video camera mounted on glasses into small electrical pulses transmitted wirelessly to electrodes implanted on the brain’s visual cortex. Read more.
SOURCE: Second Sight Medical Products, September 2020
GYROSCOPE RECEIVES FDA FAST TRACK DESIGNATION FOR GT005
Gyroscope Therapeutics announced the FDA granted Fast Track designation to GT005 for the treatment of geographic atrophy secondary to dry age-related macular degeneration. GT005, an investigational one-time AAV-based gene therapy delivered under the retina, is intended to slow the progression of GA. It’s designed for individuals with specific mutations in their Complement Factor I (CFI) gene and low levels of the CFI protein in their blood, Gyroscope says. Read more.
SOURCE: Gyroscope Therapeutics, September 2020
Gemini and FS Development to Merge & Form Public Company Focused on AMD
Gemini Therapeutics entered into a merger agreement with FS Development in which the resulting company will be renamed “Gemini Therapeutics, Inc.” The combined company’s common stock is expected to be listed on Nasdaq. Proceeds are expected to provide Gemini with the capital to develop its clinical programs and preclinical portfolio, including GEM103, Gemini’s lead product candidate for dry AMD treatment. Read more.
SOURCE: Gemini Therapeutics, FS Development Corp., October 2020
EYEVENSYS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR EYS611
Eyevensys announced the FDA granted an orphan-drug designation for EYS611 for the treatment of retinitis pigmentosa. Eyevensys is developing EYS611, a DNA plasmid that encodes for the human transferrin protein, to help patients diagnosed with RP and other degenerative retinal diseases. Transferrin is an endogenous protein that helps manage iron levels in the eye, as excessive iron has been associated with photoreceptor death in several retinal degenerative diseases. By acting as an iron chelating and neuroprotective agent, EYS611 helps slow the progression of diseases such as RP regardless of the specific genetic mutation causing the condition, the company says. Read more.
SOURCE: Eyevensys, October 2020
BAUSCH HEALTH TO ACQUIRE OPTION TO PURCHASE ALLEGRO’S OPHTHALMOLOGY ASSETS
Bausch Health Companies announced that Bausch Health (through its affiliate) entered into an agreement to acquire an option to purchase all ophthalmology assets of Allegro, including global rights for risuteganib (Luminate). The integrin-regulating therapy is believed to reduce mitochondrial dysfunction involved in intermediate dry age-related macular degeneration. Other ophthalmology assets of Allegro include ALG-1007, a topical integrin regulator under investigation for the treatment of dry eye. The option payment totaling $50 million would be made in two tranches. Read more.
SOURCE: Bausch Health Companies, September 2020
APELLIS ANNOUNCES PEGCETACOPLAN ANALYSIS ACCEPTED AT EURETINA 2020
Apellis Pharmaceuticals announced that a post hoc analysis of the Phase II FILLY study investigating intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration was accepted as a late-breaking oral presentation by EURETINA 2020 Virtual. The company says that the new analysis demonstrates that pegcetacoplan impacts the progression of nascent GA in areas of the retina outside of GA lesions. Read more
SOURCE: Apellis Pharmaceuticals, September 2020
Discovery Holds Potential for Reversing Vision Loss
An Oklahoma Medical Research Foundation identified a compound that could aid in developing therapies to help reverse vision loss from diseases such as retinopathy of prematurity and diabetic retinopathy. In a study in the October 5 online edition of the Proceedings of the National Academy of Sciences, OMRF scientists analyzed blood vessels that naturally regress and disappear in mice soon after birth. They found that levels of a specific class of cellular proteins crashed as the mice experienced normal blood vessel loss in the eye, which they hypothesized might be an important “off switch” to eliminate the vessels in a neonatal model. They identified an experimental compound that disables the proteins to trick blood vessels in diseased mice into thinking they were supposed to be regressing and naturally dying off, which reportedly occurred. Further, the compound only impacted abnormal blood vessels with slow blood flow. The normal vessels needed in a healthy eye were spared. The findings open the door to tailored therapies to reverse vision loss, the researchers say. Read more.
SOURCE: Oklahoma Medical Research Foundation, October 2020
AGTC Joins the My Retina Tracker Program as a New Scientific Collaborator
Applied Genetic Technologies Corporation, Blueprint Genetics and Foundation Fighting Blindness announced that AGTC, a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, will join the My Retina Tracker Program as a new scientific collaborator to enhance development of its investigational gene therapies for inherited retinal diseases. The program, a collaboration between Blueprint Genetics, Foundation Fighting Blindness and InformedDNA, is an open-access, no-cost program that offers individuals with IRDs easy access to high-quality genetic diagnostics and genetic counseling. Read more.
SOURCE: Applied Genetic Technologies Corporation (AGTC), Blueprint Genetics and Foundation Fighting Blindness, October 2020
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