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.
Non-resolving Subretinal Fluid in nAMD
Researchers described the clinical characteristics and visual outcomes of neovascular age-related macular degeneration (NV-AMD) patients with irregular pigment epithelium detachment (PED) and non-resolving subretinal fluid (SRF) despite continuous monthly injections of anti-vascular endothelial growth factor.
This was a retrospective case series including NV-AMD patients treated in a tertiary academic practice. Inclusion criteria were NV-AMD diagnosis, irregular PED and non-resolving SRF treated with continuous monthly anti-VEGF intravitreal injections. Data collection included best-corrected visual acuity, central macular thickness (CMT), subfoveal choroidal thickness, and type and location of PED as seen on optical coherence tomography.
A total of 738 patients with NV-AMD underwent anti-VEGF injections during the follow-up period, and 20 eyes of 19 patients (14 females and five males) met the inclusion criteria. Average age was 81.7 ±6.6 years, mean follow-up time was 32.1 ±23.5 months and mean number of injections was 31.3 ±24.2. Mean VA was 0.26 ±0.21 logMAR (Snellen 20/36) at baseline vs. 0.20 ±0.23 logMAR (Snellen 20/32) at the end of the follow-up (p=0.28). All eyes presented with subfoveal, type 1 macular neovascularization (MNV). Average subfoveal choroidal thickness changed from 189.70 ±68.46 μm at baseline to 169.00 ±63.06 μm (p<0.001) at last follow-up.
Researchers concluded that patients with type 1 NV-AMD, irregular PED and non-resolving SRF who are under continuous treatment of monthly anti-VEGF injections may maintain good visual acuity after a long period of time.
SOURCE: Hosseini H, Rabina G, Pettenkofer M, et al. Clinical characteristics and visual outcomes of non-resolving subretinal fluid in neovascular AMD despite continuous monthly anti-VEGF injections: A long-term follow-up. Graefes Arch Clin Exp Ophthalmol 2020; Nov 27. [Epub ahead of print].
Anatomical & Clinical Outcomes of nAMD Eyes Treated with Anti-VEGF
Researchers assessed the relationship between subretinal fluid (SRFL), intraretinal fluid (IRFL) and visual outcomes of neovascular age-related degeneration in routine clinical practice.
They identified treatment-naive eyes enrolled in the Fight Retinal Blindness! registry after January 2017. They graded lesion activity at each visit as: inactive; active not SRFL only (A-NSRFL only); or active SRFL only (A-SRFL only). Eyes were grouped based on initial activity: initially A-NSRFL only; or initially A-SRFL only—and further on their predominant activity status over 12 months: mostly inactive; mostly A-NSRFL only; or mostly A-SRFL only.
A total of 703 eyes were eligible for analysis. Here were some of the findings:
• Initially A-NSRFL only had similar adjusted mean 12-month VA change to initially A-SRFL eyes (5.7 vs. 6.9 letters; p=0.165), but the group’s final VA was worse (62.5 vs. 67.5 letters at 12 months; p=0.003).
• Adjusted mean 12-month VA change between the predominant activity groups was significantly different (p=0.005), with mostly inactive (7.6 letters) and mostly A-SRFL only (7.5 letters) eyes gaining more than mostly A-NSRFL only eyes (3.6 letters).
Researchers wrote that eyes with SRFL only had outcomes at one year that were similar to eyes that were mostly inactive. They added that intraretinal fluid was associated with worse visual outcomes, which they said underscored the importance of distinguishing between IRFL and SRFL when managing nAMD.
SOURCE: Nguyen V, Puzo M, Sanchez-Monroy J, et al. Association between anatomical and clinical outcomes of neovascular age-related macular degeneration treated with anti-VEGF. Retina 2020; Dec 14; [Epub ahead of print].
Systemic Medication Use and the Incidence and Growth of Geographic Atrophy in the CATT
Scientists determined associations of systemic medications with the incidence and growth of geographic atrophy in participants of the Comparison of Age-related Macular Degeneration Treatments Trials (CATT).
Participants of CATT with new untreated choroidal neovascularization in the study eye (one study eye per participant) were randomized to receive treatment with bevacizumab or ranibizumab. Participants were released from clinical trial treatment at two years and examined at approximately five years. Color fundus photographs and fluorescein angiograms taken at baseline, years one, two and five were assessed for presence and size of GA by two masked graders. Participants were interviewed about systemic medication use at baseline. Systemic medications previously reported to be associated with AMD were evaluated for associations with GA incidence in study eye using univariable and multivariable Cox models, and for association with the GA growth using linear mixed effects models.
In multivariable analysis of 1,011 study eyes without baseline GA, systemic medications—including cholinesterase inhibitor, ACE inhibitors, calcium channel blockers, beta-blockers, diuretics, aspirin, steroids, statins, hormone replacement therapy, antacids, and drugs targeting G protein-coupled receptors—weren’t associated with GA incidence in the study eye (all adjusted hazard ratios ≤1.86, p≥0.18). In multivariable analysis of 214 study eyes with longitudinal GA size measurements, calcium channel blockers were associated with higher GA growth rate (0.40 vs. 0.30 mm/year, p=0.02).
Scientists concluded that none of the systemic medications analyzed were associated with GA incidence although calcium channel blockers were associated with higher growth rate of GA in the study eye.
SOURCE: Delu S, Peiying H, Brian LV, et al; and the CATT Research Group. Systemic medication use and the incidence and growth of geographic atrophy in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT). Retina 2020; Dec 14. [Epub ahead of print].
Progression from Intermediate to Exudative AMD
Scientists evaluated the 10-year incidence of progression from intermediate to exudative age-related macular degeneration, and identified genetic and environmental factors influencing progression in a Korean population, as part of a retrospective, observational cohort study.
In 632 eyes of 418 patients (age, ≥50 years) with intermediate AMD, scientists assessed the incidence of exudative AMD from color fundus photographs and optical coherence tomography images obtained at baseline and annual visits. They acquired data regarding lifestyle variables and dietary habits with comprehensive questionnaires. And they analyzed genotyping data concerning three single nucleotide polymorphisms (SNPs): rs800292 and rs1061170 in C FH; and rs10490924 in ARMS2. Scientists estimated cumulative incidence of exudative changes using Kaplan-Meier analysis, and evaluated associated influential factors using univariate and multivariate Cox regression models.
The mean follow-up period was 3.99 ±2.85 years. Here were some of the findings:
• The cumulative incidence of progression to exudative AMD was: 5.6 percent at two years; 14.8 percent at five years; and 28.4 percent at 10 years.
• Multivariate Cox analysis revealed: age (harzard ratio [HR], 1.041; p=0.0393); family history of AMD (HR, 3.175; p=0.0184); and pre-existing exudative AMD in the fellow eye (HR, 3.186; p=5.31 x 10 -5) were positively associated with exudative changes.
• Regular green tea intake (HR, 0.632; p=0.0475) was associated with decrease in exudative changes.
• ARMS2 rs10490924 (HR, 1.482; p=0.0185) showed a significant association with AMD progression.
Scientists wrote that the annual progression rate from intermediate to exudative AMD in the Korean population was approximately 2.8 percent, which was comparable with that in Caucasians. They added that green tea intake may be a modifiable protective factor against exudative changes.
SOURCE: Joo K, Mun YS, Sang Park SJ, et al. Ten-year progression from intermediate to exudative age-related macular degeneration and risk factors–bundang AMD cohort study report 1. Am J Ophthalmol 2020; Dec 3. [Epub ahead of print].
Imaging Features Associated with Progression to GA in AMD: CAM Report 5
Experts aimed to provide an image-based description of retinal features associated with risk for development of geographic atrophy in eyes with age-related macular degeneration, as visualized with multimodal imaging anchored by structural optical coherence tomography.
As part of the Classification of Atrophy Meeting program, an international group of experts analyzed and discussed retinal multimodal imaging features in eyes with AMD associated with GA and/or risk of progression to GA. Attendees undertook pre-meeting grading exercises that were reviewed during the meeting sessions. Meeting presentations illustrated established and investigational multimodal imaging features and associated histology. These different features were then each discussed openly by the entire group to arrive at consensus definitions. These definitions were applied to 40 additional images that were graded independently by attendees, to further refine the consensus definitions and descriptions.
Consensus was reached on images with descriptors for 12 features. These features included components of outer retinal atrophy (e.g., ellipsoid zone disruption), components of complete retinal pigment epithelium and outer retinal atrophy (e.g., RPE perturbation with associated hypo- or hyper-transmission), features frequently seen in eyes with atrophy (e.g., refractile drusen) and features conferring risk for atrophy development (e.g., hyperreflective foci, drusen and subretinal drusenoid deposits).
An International consensus on terms and descriptions was reached on multimodal imaging features associated with GA and with risk for GA progression in eyes with AMD. Experts believe this information will be useful to clinicians who manage patients with AMD, researchers who study AMD disease interventions and pathogenesis, and those who design clinical trials for therapies targeting earlier AMD stages than GA expansion.
SOURCE: Jaffe GJ, Chakravarthy U, Freund KB, et al. Imaging features associated with progression to geographic atrophy in age-related macular degeneration: CAM Report 5. Ophthalmol Retina 2020; Dec 18. [Epub ahead of print].
Local Anatomic Precursors to New Onset GA in AMD as Defined on OCT
Researchers have found that, in macula-wide analyses, spectral-domain optical coherence tomography features such as drusen volume, hyperreflective foci and OCT-reflective drusen substructures independently predict onset of geographic atrophy secondary to age-related macular degeneration. They sought to identify SD-OCT features in the location of new GA prior to its onset.
The retrospective study included Age-Related Eye Disease Study 2 Ancillary SD-OCT Study Participants. Researchers analyzed longitudinally captured SD-OCT and color photographs from 488 eyes (of 488 participants) with intermediate AMD at baseline. Sixty-two eyes with sufficient image quality demonstrated new onset GA on color photographs during study years two through seven. Researchers separately segmented the area of new onset GA and one size-matched control region in the same eye, and defined the corresponding spatial volumes on registered SD-OCT images at the GA incident year, and at two, three, and four years prior. Differences in SD-OCT features between paired precursor regions were evaluated through matched-pairs analyses.
Main outcome measures included localized SD-OCT features two years prior to GA onset.
Here were some of the findings:
- Compared to paired control regions, GA precursor regions at two, three and four years prior (n=54, 33 and 25, respectively) had greater drusen volume (p=0.01, p=0.003 and p=0.003 respectively).
- At two and three years prior to GA onset, they were associated with the presence of hypertransmission (p<0.001 and p=0.03), hyperreflective foci (p<0.001 and p=0.045), OCT-reflective drusen substructures (p=0.004 and p=0.03), and loss/disruption of: photoreceptor zone, ellipsoid zone, and retinal pigment epithelium (two-year p<0.001 and three-year p=0.005-0.045).
- At four years prior, precursor regions were associated with photoreceptor zone thinning (p=0.007) and interdigitation zone loss (p=0.045).
Evolution to GA is heralded by early local photoreceptor changes and drusen accumulation, detectable four years prior to GA. These precede other anatomical heralds such as RPE changes and drusen substructure emergence detectable one to two years prior to GA. This study thus identifies earlier endpoints for GA as potential therapeutic targets in clinical trials.
SOURCE: Pasricha MV, Tai V, Sleiman K, et al; Age-related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study Group. Local anatomic precursors to new onset geographic atrophy in age-related macular degeneration as defined on optical coherence tomography. Ophthalmol Retina 2020; Dec 18. Epub ahead of print.
GA Growth & Lesion Perimeter
Researchers investigated the underlying reason for the previously observed impact of baseline lesion size, lesion number, and circularity on geographic atrophy growth rate, as part of a retrospective analysis of a multicenter, prospective, randomized controlled trial.
Participants included Age-Related Eye Disease Study (AREDS) participants with GA secondary to nonexudative age-related macular degeneration.
The investigators manually delineated atrophic lesions on color fundus photographs of 318 eyes with GA followed over at least two visits (follow-up duration=5.1 ±3 years). Researchers calculated GA area growth rate for each eye based on the first and last visit. GA perimeter-adjusted growth rate (mm/year) was defined as the ratio between GA area growth rate (mm2/year) and mean GA perimeter (mm) between the first and last visit for each eye.
Main outcome measures include GA area growth rate, growth rate of square root of GA area and GA perimeter-adjusted growth rate.
Here were some of the findings:
- GA area growth rate was strongly correlated with mean GA perimeter (r2 = 0.66).
- GA area growth rate was associated with baseline GA area (r2=0.39, p<0.001), lesion number (r2=0.10, p<0.001), and circularity index (r2=0.28, p<0.001).
- The use of square root of GA area reduced the influence of baseline GA area (but not lesion number and circularity) on GA growth rate.
- In comparison, GA perimeter-adjusted growth rate (0.098 ±0.062 mm/year) was uncorrelated with baseline GA area (r2=0.005, p=0.20), lesion number (r2=0.00009, p=0.86) and circularity index (r2=0.007, p=0.14).
- GA perimeter-adjusted growth rate was 50 percent higher in eyes whose fellow eyes had GA at any visit (0.102 ±0.062 mm/year) than in eyes whose fellow eyes never developed GA during follow-up (0.068 0.049 mm/year).
Researchers wrote that the growth rate of GA area was strongly associated with lesion perimeter. They added that this relationship explained the previously observed influences of baseline GA size, lesion number and circularity on GA growth rate. Furthermore, researchers reported that the GA perimeter-adjusted growth rate was uncorrelated with the three morphological factors and may serve as a surrogate outcome measure to monitor GA progression in future studies.
SOURCE: Shen LL, Sun M, Ahluwalia A, et al. Geographic atrophy growth is strongly related to lesion perimeter: Unifying effects of lesion area, number, and circularity on growth. Ophthalmol Retina 2020; Dec 8. [Epub ahead of print].
SD-OCT Predictors of VA in SCORE2
Researchers evaluated the association between baseline demographic and SD-OCT features with visual acuity in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) over two years, as part of a post-hoc analysis of prospective clinical trial data.
Participants included 362 SCORE2 participants with macular edema secondary to central retinal or hemi-retinal vein occlusion.
SD-OCT volume scans were assessed at the SCORE2 reading center at baseline, month 01 (M01), month 06 (M06), month 12 (M12) and month 24 (M24) for central subfield thickness (CST), subretinal fluid, intraretinal fluid, vitreoretinal interface abnormalities, disorganization of retinal inner layers (DRIL) and ellipsoid zone (EZ) within the central subfield (CSF). Main outcome measures included VA at M06, M12 and M24.
Mean baseline age was 68.9 years. Here were some of the findings:
- Mean VA at M01 was 63.2 letters and central subfield thickness was 299.7 microns.
- At M01, subretinal fluid was seen in 28.5 percent of subjects, intraretinal fluid was seen in 67.2 percent of subjects and DRIL was seen in 73.8 percent of subjects, mostly within CSF; and EZ was absent in 9.8 percent of subjects and patchy in 31.7 percent of subjects.
- In multivariate analysis including all M01 demographics and SD-OCT parameters and their association with VA at M06, M12 and M24, VA at M01 remained significant across all time points up to M24 (p<0.001).
Scientists found in this two-year follow-up of eyes that were treated both per protocol and off protocol for RVO, visual acuity at M01 was an important predictor of long-term vision and change in vision. They wrote that establishing predictors of visual recovery helps identify causes for poor responders to treatment in patients with RVO.
SOURCE Etheridge T, Blodi B, Oden N, et al. Spectral domain optical coherence tomography predictors of visual acuity in the study of comparative treatments for retinal vein occlusion 2 (SCORE2). Ophthalmol Retina 2020; Dec 26. [Epub ahead of print].
Macular Microvascular Change Association with Non-Perfusion in BRVO
Investigators evaluated the correlation between macular microvascular alterations on optical coherence tomography angiography and retinal ischemia on ultra-widefield fluorescein angiography (UWF FA) in eyes with branch retinal vein occlusion, as part of a cross-sectional study.
This prospective study was performed between September 2019 and June 2020 at Yeungnam University Medical Center. Investigators included 60 patients with treatment-naïve BRVO. Two independent, masked graders analyzed OCTA parameters, including vessel density, skeletal density, fractal dimension (FD) and UWF FA parameters, including retinal non-perfusion area (NPA) and ischemic index (ISI) from various concentric regions (perimacular region, 0.5 to 3 mm radius; near-peripheral region, 3 to 10 mm; mid-peripheral region, 10 to 15 mm; far peripheral region, >15 mm). A repeated measures analysis of variance test and a paired T test were performed for intervisit and interregional comparisons, and Pearson correlation coefficient and multivariate regression analyses were performed to examine the correlation between UWF FA and OCTA parameters.
Here were some of the findings:
• The OCTA parameters from the superficial and deep capillary plexuses (DCP) were significantly correlated with NPA and ISI in all concentric regions.
• After adjusting for several covariates, all OCTA parameters revealed a significant association with ISI on UWF FA.
• OCTA parameters from DCP were significantly correlated with concentrations of placental growth factor and vascular endothelial growth factor.
• Although all OCTA parameters achieved successful results in obtaining area under the curve >0.9 to detect severe retinal ischemia, defined as ISI >10 percent, FD reduction in DCP was the most reliable parameter (AUC=0.948, p<0.001), and 5.39 percent was the best cutoff point for predicting ISI >10 percent.
Investigators concluded that OCTA is a useful noninvasive tool for evaluation of macular microvasculature and predicting peripheral non-perfusion in eyes with BRVO.
SOURCE: Ryu G, Park D, Lim J, et al. Macular microvascular changes and their correlation with peripheral non-perfusion in branch retinal vein occlusion. Am J Ophthalmol 2021; Jan 4. [Epub ahead of print].
Changes in Subfoveal Choroidal Thickness Following Intravitreal Dexamethasone Implant Therapy for DME
Investigators evaluated changes in subfoveal choroidal thickness (SFCT) and their relationship with best-corrected visual acuity and optical coherence tomography parameters after intravitreal dexamethasone implant (DEX) injections for diabetic macular edema.
Eighty-one eyes treated with DEX injections for DME were evaluated for BCVA, central macular thickness (CMT), SFCT and OCT parameters at baseline and weeks seven and 14.
Here were some of the findings:
- The mean baseline SFCT significantly decreased at weeks seven (p<0.001) and 14 (p<0.001).
- At week seven, each 1-μm reduction in CMT and five Early Treatment Diabetic Retinopathy Study letters (-0.1 logMAR) improvement was associated with SFCT reductions of 0.09 (p=0.002) and 3.91 (p=0.044) μm, respectively.
- At week 14, each 1-μm reduction in CMT was associated with a 0.14-μm reduction in SFCT (p<0.001).
- Eyes with good functional and anatomical responses exhibited significantly greater SFCT reductions.
- Subretinal fluid resulted in greater SFCT changes (p=0.039) and better BCVA (p=0.033) at week seven.
- A continuous ellipsoid zone/interdigitation zone layer was associated with a smaller mean SFCT at week seven (p=0.002) and better BCVA at weeks seven and 14 (both, p<0.001).
Investigators reported that changes in SFCT after DEX injection therapy for DME may predict anatomical and functional outcomes and correlate with OCT features that are known as predictors of treatment response.
SOURCE: Moon KY, Choi SY, Song JH. Changes in subfoveal choroidal thickness following intravitreal dexamethasone implant therapy for diabetic macular edema. Retina 2020; Dec 10. [Epub ahead of print].
Reticular Pseudodrusen in Late-onset Retinal Degeneration
Scientists characterized the association of reticular pseudodrusen (RPD) with late-onset retinal degeneration (L-ORD) using multimodal imaging, as part of a prospective, two-center, longitudinal case series of 29 cases with L-ORD.
All subjects were evaluated within a three-year interval with near-infrared reflectance, fundus autofluorescence and spectral-domain optical coherence tomography. In addition, a subset of patients also underwent indocyanine green angiography, fundus fluorescein angiography, mesopic microperimetry and multifocal electroretinography.
Main outcome measures included prevalence, topographic distribution and temporal phenotypic changes of RPD in L-ORD.
A total of 29 molecularly confirmed L-ORD cases were included in this prospective study. Here were some of the findings:
- RPD was detected in 18 cases (62 percent) at baseline, of which 10 were male.
- The prevalence of RPD varied with age.
- The mean age of RPD patients was 57.3 ±7.2 years.
- RPD wasn’t seen in cases below the fifth decade (n=3 patients) or in the eighth decade (n=5 patients).
- RPD were found commonly in the macula with relative sparing of the fovea and were also identified in the peripheral retina.
- The morphology of RPD changed with follow-up.
- Two cases (3 eyes) demonstrated RPD regression.
Scientists wrote that RPD is found frequently in cases with L-ORD and at a younger age than in individuals with AMD. They added that RPD exhibited quick formation and collapse, change in type and morphology with time, relative foveal-sparing and also has a peripheral retinal location in L-ORD.
SOURCE: Borooah S, Papastavrou V, Lando L, et al. Reticular pseudodrusen in late-onset retinal degeneration. Ophthalmol Retina 2020; Dec 19. [Epub ahead of print].
GENENTECH’S FARICIMAB MEETS ENDPOINTS IN MULTIPLE TRIALS
Genentech announced announced topline results from two identically designed global Phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people with neovascular age-related macular degeneration. Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks, the company says. Nearly half (45 percent) of people in both studies were treated with faricimab every 16 weeks during the first year. Read more.
In December, Genentech announced positive topline results from two identically designed global Phase III studies, YOSEMITE and RHINE, evaluating the investigational bispecific antibody faricimab in people with diabetic macular edema. Both studies met their primary endpoints and showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated noninferior visual acuity gains compared with aflibercept given every eight weeks. Faricimab was generally well-tolerated with no new safety signals identified. In addition, the Phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. Read more.
SOURCE: Genentech, January/December 2020
Novartis Reports Topline Results From Second Phase III Trial of Beovu
Novartis announced positive findings from the Phase III KESTREL study, which assessed the efficacy and safety of Beovu (brolucizumab) 3 mg and 6 mg in diabetic macular edema. Following KITE, KESTREL is the second Phase III study of Beovu in DME. The recent trial met its primary endpoint of non-inferiority in change in best-corrected visual acuity from baseline of Beovu 6 mg to aflibercept 2 mg at year one. And it also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 521. (Beovu 6 mg is the marketed dose for wet AMD.) Read more.
SOURCE: Novartis, December 2020
Regenxbio Announces Dosing of First Patient in Phase II ALTITUDE Trial
Regenxbio announced the first patient was dosed in ALTITUDE, a Phase II trial to evaluate the suprachoroidal delivery of RGX-314 using the SCS Microinjector for the treatment of diabetic retinopathy. The trial is expected to enroll approximately 40 patients with DR across two cohorts. Patients will be randomized to receive RGX-314 vs. observational controls at a 3:1 ratio, and two dose levels of RGX-314 will be evaluated. The primary endpoint is the proportion of patients that improve in DR severity based on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at 48 weeks. Read more.
SOURCE: Regenxbio, December 2020
ASCLEPIX DOSES FIRST PATIENT IN PHASE I/IIA TRIAL OF AXT107
AsclepiX Therapeutics announced the first patient was dosed in the Phase I/IIa CONGO clinical trial to evaluate the safety and bioactivity of AXT107 in patients with diabetic macular edema. In December 2020, the FDA cleared the Investigational New Drug application for AXT107 for the treatment of retinal diseases including DME, neovascular age-related macular degeneration and macular edema following retinal vein occlusion. AXT107 is an investigational drug candidate that inhibits VEGF-A and VEGF-C, and activates Tie2. Read more.
SOURCE: AsclepiX Therapeutics, January 2021
CLEARSIDE ANNOUNCES FIRST PATIENTS ENROLLED IN PHASE I/IIA TRIAL OF CLS-AX
Clearside Biomedical announced that the first patients were enrolled in its Phase I/IIa clinical trial of CLS-AX (axitinib injectable suspension) in individuals with neovascular age-related macular degeneration. Clinical sites are now screening wet AMD patients for the trial, known as OASIS, involving CLS-AX, a proprietary suspension of axitinib for suprachoroidal injection. Read more.
SOURCE: Clearside Biomedical, January 2021
GEMINI RECEIVES FDA FAST TRACK DESIGNATION FOR GEM103
Gemini Therapeutics announced that GEM103, the company’s investigational treatment for dry age-related macular generation, was granted FDA Fast Track designation. Gemini is evaluating GEM103, a recombinant, human complement factor H. The company’s Phase IIa ReGAtta study is evaluating GEM103 in patients with geographic atrophy secondary to dry AMD. Read more.
SOURCE: Gemini Therapeutics, January 2021
FDA Accepts Rezolute’s IND Application for RZ402
Rezolute announced the FDA accepted its Investigational New Drug application for RZ402, an orally available plasma kallikrein inhibitor that is in development for the treatment of diabetic macular edema. The company expects to initiate a Phase I, first-in-human clinical study with RZ402 in the first quarter of 2021. The company says RZ402, by inhibiting the formation of kallikrein, blocks the pro-inflammatory, pro-coagulant and fluid-leakage cascade triggered by up-activation of the contact activation system in the setting of DME and other vascular-mediated diseases. Read more.
OPTOS INTRODUCES UWF IMAGING ADVANCEMENTS
Optos’ line of ultra-widefield imaging devices are offering several advancements:
• The Daytona model has improved optics for visualization across the optomap image and automatic laterality detection to improve image capture time. It also features an updated design and user interface.
• The Silverstone model, which offers optomap-guided swept source optical coherence tomography, includes a Repeat Scan tool for monitoring changes over time, and an Explorer mode to display OCT scan type and location.
In addition, auto contrast is available for angiography capture. Learn more about the company
Source: Optos, December 2020
Prevent Blindness Calls for Nominations
Prevent Blindness is calling for nominations for the 2021 Jenny Pomeroy Award for Excellence in Vision and Public Health, and the second annual Rising Visionary Award. The deadline for submissions for both awards is February 5. Read more.
SOURCE: Prevent Blindness, January 2021
Volk Releases ClearPod to Solve Mask-related Fogging
Volk Optical released its newest product, the ClearPod, to solve the problem of mask-related fogging during fundus exams. This patent-pending design was created in collaboration with Bradley Sacher, MD, a cataract specialist and Jeremy Wingard, MD, a glaucoma specialist at Wheaton Eye Clinic. When a patient breathes naturally while wearing a mask, air escapes through the gaps in the mask and accumulates on the lens surface causing condensation and obstructing views of the retina and slowing down the exam. The ClearPod clips securely onto the Volk fundus lens and form a barrier, directing air currents away from the lens surface. Read more.
SOURCE: Volk Optical, January 2021
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