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.
HAWK and HARRIER: Trials of Brolucizumab for nAMD
Two similarly designed, Phase III trials (HAWK and HARRIER) compared brolucizumab, a single-chain antibody fragment that inhibits vascular endothelial growth factor-A, with aflibercept to treat neovascular age-related macular degeneration, as part of double-masked, multicenter, active-controlled, randomized trials sponsored by brolucizumab’s maker, Novartis.
Participants (n=1,817) included individuals with untreated, active choroidal neovascularization due to AMD in the study eye. Individuals were randomized to intravitreal brolucizumab 3 mg (HAWK only), 6 mg or aflibercept 2 mg. After loading with three monthly injections, brolucizumab-treated eyes received an injection every 12 weeks (q12w) and were interval-adjusted to every eight weeks (q8w) if disease activity was present; aflibercept-treated eyes received q8w dosing.
The primary hypothesis was noninferiority in the mean best-corrected visual acuity change from baseline to week 48 (margin: four letters). Other key endpoints included the percentage of individuals who maintained q12w dosing through week 48 and anatomical outcomes. Here were some of the findings:
• At week 48, each brolucizumab arm demonstrated noninferiority to aflibercept in BCVA change from baseline (least squares [LS] mean: +6.6 [6 mg] and +6.1 [3 mg] letters with brolucizumab vs. +6.8 letters with aflibercept in HAWK; +6.9 [brolucizumab 6 mg] vs. +7.6 [aflibercept] letters in HARRIER; p<0.001 for each comparison).
• More than half of the brolucizumab 6 mg-treated eyes were maintained on q12w dosing through week 48 (56 percent in HAWK and 51 percent in HARRIER).
• At week 16, following identical treatment exposure, fewer brolucizumab 6 mg-treated eyes had disease activity vs. aflibercept in HAWK (24 percent vs. 34.5; p=0.001) and HARRIER (22.7 percent vs. 32.2 percent; p=0.002).
• Greater central subfield thickness reductions from baseline to week 48 were observed with brolucizumab 6 mg vs. aflibercept in HAWK (LS mean: -172.8 μm vs. -143.7 μm; p=0.001) and HARRIER (LS mean: -193.8 μm vs. -143.9 μm; p<0.001).
• Anatomical retinal fluid outcomes favored brolucizumab over aflibercept.
• Overall adverse event rates were generally similar with brolucizumab and aflibercept.
Researchers wrote that anti-VEGF rescue therapy has a potential role in select cases of laser treated PDR with persistent new vessels, and no evidence of traction to achieve regression of neovascularization.
Source: Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology 2019; Apr 12. [Epub ahead of print].
Port Delivery System with Ranibizumab for nAMD: Ladder Clinical Trial
Researchers analyzed the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for treatment of neovascular age-related macular degeneration, as part of the Genentech-sponsored Ladder trial, a Phase II, multicenter, randomized, active treatment-controlled clinical study.
Participants included individuals diagnosed with nAMD within nine months, who had received ≥2 prior anti-vascular endothelial growth factor intravitreal injections and who were responsive to treatment.
Subjects were randomized 3:3:3:2 to receive the PDS filled with ranibizumab 10 mg/mL, 40 mg/mL and 100 mg/mL formulations, or monthly intravitreal ranibizumab 0.5 mg injections. Main outcome measures included time to first implant refill assessed when the last enrolled subject completed the nine-month visit, improvements in best-corrected visual acuity and central foveal thickness, and certain safety benchmarks.
The primary analysis population included 220 individuals, in the following breakdown: (using the PDS) 58 subjects in the 10 mg/mL arm; 62 subjects in the 40 mg/mL arm; 59 subjects in the 100 mg/mL arm; and 41 subjects in the monthly intravitreal ranibizumab 0.5 mg arm. Here are some of the findings:
• With the PDS, median time to first implant refill was 8.7 months in the 10 mg/mL arm, 13 months in the 40 mg/mL arm and 15 months in the 100 mg/mL arm.
• At month nine, the adjusted mean BCVA change from baseline was -3.2 Early Treatment Diabetic Retinopathy Study letters in the PDS 10 mg/mL arm, -0.5 ETDRS letters in the PDS 40 mg/mL arm, +5 ETDRS letters in the 100 mg/mL arm and +3.9 ETDRS letters in the monthly intravitreal ranibizumab 0.5 mg arm.
• At month nine, the adjusted mean CFT change from baseline was similar in the PDS 100 mg/mL and the monthly intravitreal ranibizumab 0.5 mg arms.
• The optimized PDS implant insertion and refill procedures were generally well-tolerated.
• After surgical procedure optimization, the postoperative vitreous hemorrhage rate was 4.5 percent (7/157; one event classified as serious).
• Researchers found no evidence of implant clogging.
Researchers determined in the Phase II Ladder trial that the PDS was generally well-tolerated and demonstrated a dose response across multiple endpoints in individuals with nAMD. They found that the PDS 100 mg/mL arm had visual and anatomic outcomes comparable with monthly intravitreal ranibizumab 0.5 mg injections, but with a reduced total number of ranibizumab treatments. Researchers wrote that the PDS had the potential to reduce treatment burden in nAMD while maintaining vision.
Source: Campochiaro PA, Marcus DM, Awh CC, et al. The port delivery system with ranibizumab for neovascular age-related macular degeneration: Results from the randomized phase 2 ladder clinical trial. Ophthalmology 2019; April 1. [Epub ahead of print].
Reactivation in Type 3 Neovascularization After Initial Treatment
Investigators evaluated the long-term incidence and timing of reactivation in individuals with type 3 neovascularization who were treated with three monthly anti-vascular endothelial growth factor injections.
A total of 179 individuals (179 eyes) diagnosed with type 3 neovascularization with a dry macula after three monthly anti-VEGF loading injections were included in this retrospective study. After the initial treatment, individuals were followed up without further injection until the first reactivation. Investigators recorded the incidence and timing of the first reactivation and assessed factors predictive of early reactivation (≤ six months after the third anti-VEGF injection). Here were some of the findings:
• During a mean follow-up of 37.5 ±18.8 months, the first reactivation was noted in 145 subjects (81 percent) at a mean of 6.6 ±4.1 months after the third injection.
• In 94 eyes (64.8 percent), reactivation was noted two to six months after the third injection, while in 37 eyes (25.5 percent) it was noted seven to 12 months after the third injection; in 14 eyes (9.7 percent), reactivation was noted after this period of time.
• The incidence of early reactivation was higher in women (p=0.014) and individuals with a thicker choroid (p=0.026).
Investigators found that, in individuals with type 3 neovascularization, almost all reactivation was detected within 15 months of the third anti-VEGF injection, suggesting the need for close follow-up and detailed examinations during this period. They recommended that females with thick choroids be monitored more frequently during this early period.
SOURCE: Kim JH, Chang YS, Kim JW, et al. Long-term incidence and timing of reactivation in patients with type 3 neovascularization after initial treatment. Graefes Arch Clin Exp Ophthalmol 2019; Apr 1. [Epub ahead of print].
Association of CD11b+ Monocytes and Anti-VEGF Injections in Treating nAMD & PCV
Researchers looked at whether the proportion of CD11b+ circulating monocytes was associated with the number of anti-vascular endothelial growth factor injections in neovascular age-related macular degeneration and polypoidal choroidal vasculopathy.
The observational cohort study collected data from Jan. 1, 2010, through Dec. 31, 2013, and from Jan. 1, 2015, through Dec. 31, 2018. Fresh venous blood samples were acquired for flow cytometric immune studies in individuals with neovascular AMD or PCV receiving treatment with aflibercept or ranibizumab as needed for 36 months. Individuals (n=81) without immune diseases were consecutively recruited from a single center in Denmark.
Main outcomes and measures included estimation of the number of intravitreal anti-VEGF injections given at 12, 24 and 36 months by the proportion of CD11b+ circulating monocytes and the correlation between these values. The angiogenic role of CD11b+ circulating monocytes was further evaluated by investigating the expression of the known proangiogenic receptor CCR2. Eighty-one individuals were included in the analysis (54 percent women; mean age: 76 ±7] years). Here were some of the findings:
• The proportion of CD11b+ monocytes at baseline positively estimated the future number of anti-VEGF injections at 12 months (ρ=0.77; CI, 0.35 to 0.93; p=0.004), 24 (ρ=0.82; CI, 0.44 to 0.95; p=0.002) and 36 months (ρ=0.78; CI, 0.34 to 0.94; p=0.005).
• This association was also found retrospectively in a larger sample of individuals with neovascular AMD: at 12 months (ρ=0.46; CI, 0.16 to 0.68; p=0.004), 24 months (ρ=0.49; CI, 0.20 to 0.70; p=0.002) and 36 months (ρ=0.65; CI, 0.41 to 0.80; p<0.001).
• This association was also found retrospectively in a larger sample of individuals with individuals with PCV at 12 (ρ=0.27; CI, -0.28 to 0.68; p=0.30), 24 (ρ=0.60; CI, 0.12 to 0.85; p=0.02) and 36 months (ρ=0.70; CI, 0.27 to 0.90; p=0.005).
• The findings suggested that this association was not specific to AMD but rather reflected VEGF activity in neovascularization.
• CD11b+ monocytes highly co-expressed CCR2, a monocytic marker of proangiogenic activity.
Researchers wrote that the proportion of circulating CD11b+ monocytes estimated and correlated with the number of anti-VEGF injections in individuals with neovascular AMD and PCV. They added that additional longitudinal studies would be needed to determine whether the findings had clinical relevance to influence treatment algorithms or provide novel targets for medical therapy.
SOURCE: Subhi Y, Krogh Nielsen M, Molbech CR, et al. Association of CD11b+ monocytes and anti-vascular endothelial growth factor injections in treatment of neovascular age-related macular degeneration and polypoidal choroidal vasculopathy. JAMA Ophthalmol 2019; Mar 7. [Epub ahead of print].
Precursors & Development of GA with Autofluorescence Imaging
Researchers described the sequence of events leading to development of geographic atrophy in age-related macular degeneration with fundus autofluorescence imaging, as part of a post hoc analysis of FAF images from the Age-Related Eye Disease Study 2.
FAF images of 120 eyes (109 individuals) with incident GA and at least two years of preceding FAF images were included. Researchers stacked and aligned images of incident GA over FAF images of preceding annual visits. They assessed regions of retina that developed into incident GA on prior years' FAF images. These regions, defined as precursor lesions, were classified as Minimal ChangeAF, Predominant HypoAF (decreased AF), Predominant HyperAF (increased AF) and MixedAF.
Researchers evaluated the natural progression in precursor lesions leading to GA formation, and associations with incident GA size and GA enlargement rate. Here were some of the findings:
• Incident GA had a mean area of 1.00 mm2 (range: 0.15 to 8.22 mm2) and an enlargement rate of 0.97 mm2/year (SD 1.66).
• Predominant HypoAF was the most common precursor lesion, increasing from 42 to 81 percent over three years prior to onset of GA.
• Almost 30 percent of eyes had Minimal ChangeAF three years prior to GA.
• Among the other precursors, 70 percent progressed to Predominant HypoAF before developing GA.
• The type of precursor lesion wasn’t associated with incident GA area.
• GA evolving from Minimal ChangeAF precursor lesions was associated with faster GA enlargement rates compared to other precursor lesion classes.
Researchers used image registration to identify changes in AF mages prior to onset of GA. They reported that decreased autofluorescence was the most common change, although minimal changes were also seen in a third of the images. In addition, they found that incident GA that arose from predominantly normal AF was associated with faster enlargement rates compared with GA arising from abnormal AF. Finally, researchers noted that faster GA enlargement rates were also associated with incident GA size, area of surrounding abnormal autofluorescence and presence of reticular pseudodrusen.
SOURCE: Holmen IC, Aul B, Pak JW, et al. Precursors and development of geographic atrophy with autofluorescence imaging: Age-Related Eye Disease Study 2 Report No. 18. Ophthalmology Retina 2019; April 12. [Epub ahead of print].
Features of RPE & Chorioretinal Characteristics in Eyes with Early AMD & Subretinal Drusenoid Deposits
Researchers assessed the features of the retinal pigment epithelium on optical coherence tomography in eyes with early age-related macular degeneration and subretinal drusenoid deposits.
Investigators counted the number of type 3 neovascularization lesions and estimated the incidence of multiple lesions in an eye. In addition, they estimated the distance from the fovea to the lesion, and the geographic location of the lesion.
They classified the eyes into three types: nonundulating RPE; undulating RPE; and wedge-shaped RPE. They also compared the retinal vessel densities, retinal thickness and choroidal thickness in a 3-mm-diameter zone.
• A total of 33 eyes were classified as nonundulating RPE, 27 eyes were classified as undulating RPE and 20 eyes were identified as wedge-shaped RPE eyes.
• The vascular densities of the superficial and deep capillary plexus showed differences: nonundulating RPE group (23.93 ±2.26 percent and 23.54 ±1.78 percent); undulating RPE group (22.29 ±2.80 percent and 21.94 ±2.42 percent); and wedge-shaped RPE group (21.93 ±2.7 percent and 20.63 ±2.42 percent, p=0.010 and p<0.001).
• Mean retinal thicknesses and choroidal thicknesses were also different. The respective findings were: nonundulating RPE group (298.26 ±13.81 µm and 180.08 ±55.49 µm); undulating RPE group (285.29 ±21.88 µm and 148.45 ±55.08 µm); and wedge-shaped RPE group (274.86 ±20.62 µm and 135.75 ±39.77 µm) (p=0.001 and p=0.007).
Researchers reported that altered features of the RPE on optical coherence tomography might indicate advancement in disease and be part of an overall degeneration process in these eyes.
SOURCE: Jang S, Park SY, Ahn SM, et al. Morphologic features of the retinal pigment epithelium and associated chorioretinal characteristics in eyes with early age-related macular degeneration and subretinal drusenoid deposits. Retina. 2019; Apr 2. [Epub ahead of print].
Retinal Nonperfusion Characteristics on Ultra-widefield Angiography in Severe NPDR and PDR
Investigators identified a threshold of retinal nonperfusion for the presence of retinal neovascularization, and the distribution and area of retinal nonperfusion in eyes with severe nonproliferative diabetic retinopathy, PDR, neovascularization of the optic disc (NVD) and retinal neovascularization elsewhere (NVE).
This cross-sectional image analysis was performed between Sept. 24, 2018, and Oct. 24, 2018, in a multicenter national study in the United Kingdom. Baseline images were obtained from two completed randomized clinical trials (Ranibizumab for Diabetic Macular Edema Panretinal Photocoagulation [RDP] study and Clinical Efficacy of Intravitreal Aflibercept vs. Panretinal Photocoagulation for Best Corrected Visual Acuity in Patients With Proliferative Diabetic Retinopathy at 52 Weeks [CLARITY] study). The RDP study recruited eyes with severe NPDR between April 1, 2014, and Dec. 31, 2015, and the CLARITY study recruited eyes with PDR between Aug. 22, 2014, and Nov. 20, 2015. The study included ultra-widefield angiography images of eyes with no prior panretinal photocoagulation treatment.
Main outcomes and measures included the total area of retinal nonperfusion, the area of posterior pole retinal nonperfusion and the area of peripheral retinal nonperfusion.
A total of 92 individuals (92 eyes) were included in the study: 59 in the PDR group (mean age: 42 ±15 years; 20 female [33.9 percent] and 33 in the NPDR group (mean age: 63 ±10 years; 30 female [9.1 percent]). Forty eyes had NVE and 19 had NVD with or without NVE. Here were some of the findings:
• Investigators identified a retinal nonperfusion threshold of 118.3 disc areas with a specificity of 84.9 percent (CI, 68.1 to 94.9 percent) for PDR.
• The median area of retinal nonperfusion was 67.8 DA (CI, 44.2 to 107.3 DA) in the NPDR eyes and 147.9 DA (CI, 127.4 to 173.5 DA) for eyes with proliferative changes, with a difference of 69 DA (CI, 42.2 to 97.7 DA; p<0.001).
• No difference was found in the median area of posterior nonperfusion between NPDR and PDR, with a difference of 0 DA (CI, -6.7 to 5.2 DA; p=0.56).
• Regarding peripheral nonperfusion, NPDR eyes measured 64.1 DA and PDR eyes measured 130.6 DA, with a difference of 70.8 DA (CI, 48.4 to 94.9 DA; p<0.001).
• Eyes with NVD had the largest total area of retinal nonperfusion, with a difference of 65.1 DA (CI, 28.6 to 95.8 DA; p<0.001) compared with eyes with only NVE.
Investigators wrote that these findings suggested that eyes with at least 107.3 DA of nonperfusion were at risk of proliferative disease, and eyes with NVD had the largest area of retinal nonperfusion.
SOURCE: Nicholson L, Ramu J, Chan EW, et al. Retinal nonperfusion characteristics on ultra-widefield angiography in eyes with severe nonproliferative diabetic retinopathy and proliferative diabetic retinopathy. JAMA Ophthalmol 2019; Apr 11. [Epub ahead of print].
ICGA-guided Focal Navigated Laser Photocoagulation for DME
Researchers evaluated the efficacy of indocyanine-green angiography-guided navigated focal laser photocoagulation for diabetic macular edema, as part of a prospective, interventional case series.
Six individuals (eight eyes) were enrolled in the study. Researchers performed fluorescein angiography and ICGA using the Heidelberg Retina Angiogram 2. They delivered navigated focal laser photocoagulation to the microaneurysms on ICGA using the Navilas system (OD-OS). Researchers measured central retinal thickness and macular volume by the Cirrus HD-OCT (Carl Zeiss Meditec). At six months, they compared the best-corrected visual acuity, CRT and MV to the values measured prior to procedures. They measured distances from the center of the fovea to the closest microaneurysms on pre-planned Navilas images. All eyes had a previous treatment history. Here were some of the findings:
• At six months, ICGA-guided navigated focal laser photocoagulation significantly reduced the CRT and MV (p<0.05), and improvement was found in the BCVA (p<0.05).
• At three months, five out of eight eyes (63 percent) underwent additional ICGA-guided navigated focal laser photocoagulation due to remnants of MAs that had been confirmed by ICGA.
• No observed recurrence of edema was found after the ICGA-guided navigated focal laser photocoagulation during the six-month follow-up.
• The mean distance from the center of the fovea to the closest MAs was 624.8 ±377.7 μm (range: 336 to 1,438.9 μm).
Researchers determined that their data suggests that ICGA-guided navigated focal laser photocoagulation might be effective for the treatment of DME.
SOURCE: Nozaki M, Kato A, Yasukawa T, et al. Indocyanine green angiography-guided focal navigated laser photocoagulation for diabetic macular edema. Jpn J Ophthalmol 2019; Feb 26. [Epub ahead of print].
Posteriorly Inserted Vitreous Base After Vitrectomy
Investigators determined the preoperative characteristics, intraoperative and postoperative complications, and outcomes of eyes with a posteriorly inserted vitreous base.
In the retrospective, observational, consecutive case series at two academic centers, 37 individuals were studied who had a posteriorly inserted vitreous base noted during vitrectomy. A posteriorly inserted vitreous base was defined as posterior hyaloid membrane insertion located posterior to the vortex veins. Fifteen eyes were analyzed in a histopathologic study of donor eyes to determine the average distance of the ora serrata from the vortex veins, as investigators noted that this distance was uncertain. Here were some of the findings:
• A posteriorly inserted vitreous base was identified during vitrectomy in the following eyes: 31 with rhegmatogenous retinal detachment (84 percent); four with macular holes (11 percent); one with vitreous hemorrhage; and one with epiretinal membrane.
• Adjunctive buckle was used in 24 percent of eyes; 54 percent had 360-degree laser.
• Average number of tears seen preoperatively in those with rhegmatogenous retinal detachment was 3.1.
• Thirty percent of eyes had new breaks identified intraoperatively.
• Forty-one percent of eyes had lattice degeneration; new breaks were found in 40 percent of eyes with lattice.
• Thirteen percent of rhegmatogenous retinal detachments developed proliferative vitreoretinopathy.
• Average distance from the ora serrata to the vortex veins was 7.6 mm.
Investigators determined that any eye undergoing vitrectomy might have a posteriorly inserted vitreous base, but those with a high number of retinal breaks and lattice near the equator might be at highest risk. They added that redetachment and proliferative vitreoretinopathy still occurred in the study, despite knowledge of the disorder and adjuvant treatments.
SOURCE: Sohn EH, Strohbehn A, Stryjewski T, et al. Posteriorly inserted vitreous base: Preoperative characteristics, intraoperative findings, and outcomes after vitrectomy. Retina 2019; Feb 15. [Epub ahead of print].
NOVARTIS ANNOUNCES FDA FILING OF BROLUCIZUMAB
Novartis announced that the FDA accepted the company's Biologics License Application for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration. Seeking to make brolucizumab available as quickly as possible, Novartis used a priority review voucher to expedite FDA review. If approved by the FDA, Novartis anticipates launching brolucizumab by the end of 2019. The regulatory application is primarily based on Phase III data from the HAWK and HARRIER trials (described above). The primary endpoint of these studies was non-inferiority to aflibercept in mean change in best-corrected visual acuity from baseline to week 48. HAWK and HARRIER are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 starting with a 12-week dosing regimen, Novartis says. Read more.
SOURCE: Novartis, April 2019
B+L LAUNCHES LOTEMAX SM 0.38%
Bausch + Lomb began distributing its Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38% to U.S. pharmaceutical distributors, after receiving final approval by the FDA on Feb. 22. The new gel drop formulation of loteprednol etabonate was designed with novel SubMicron technology for efficient penetration to key ocular tissues at a low preservative level and a pH close to human tears, the company says. It’s indicated for the treatment of postoperative inflammation and pain following ocular surgery. B+L says that Lotemax SM delivers a submicron particle size and provides two times greater penetration to the aqueous humor as compared with Lotemax Gel (loteprednol etabonate ophthalmic gel) 0.5%. In addition, the company says it was formulated with moisturizing ingredients, a pH close to that of human tears and the lowest BAK preservative percentage in a loteprednol etabonate formulation. Read more.
SOURCE: Bausch + Lomb, April 2019
Alcon Debuts as Independent Company
Alcon announced its debut as an independent, publicly traded company and the completion of its separation from Novartis. The company’s shares began trading on the SIX Swiss Exchange and New York Stock Exchange under the symbol “ALC.” Alcon describes itself as having a global presence in 74 countries and serving patients in more than 140, with growing businesses in emerging markets. Read more.
SOURCE: Alcon, April 2019
OPHTHOTECH OBTAINS EXCLUSIVE GLOBAL LICENSE TO AAV GENE THERAPY PROGRAM FOR BEST1-RELATED RETINAL DISEASES
Ophthotech announced that the company entered into an exclusive global license agreement with the University of Pennsylvania, including the Perelman School of Medicine at the University of Pennsylvania, the University of Pennsylvania School of Veterinary Medicine and the University of Florida Research Foundation, for rights to develop and commercialize novel adeno-associated virus gene therapy product candidates for the treatment of Best vitelliform macular dystrophy and other diseases related to mutations to the BEST1 gene. Read more.
Source: Ophthotech, April 2019
AERIE INITIATES PHASE II CLINICAL TRIAL OF AR-1105
Aerie Pharmaceuticals commenced patient dosing in a Phase II clinical trial of AR-1105, its investigational dexamethasone intravitreal implant, in individuals with macular edema due to retinal vein occlusion. The study will be conducted at approximately 20 centers in the United States and enroll up to 45 patients. The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the AR-1105 dexamethasone intravitreal implant. The study will be conducted in two stages. Read more.
SOURCE: Aerie Pharmaceuticals, March 2019
AERPIO DRUG DOESN’T MEET PRIMARY ENDPOINT IN DIABETIC RETINOPATHY
Aerpio Pharmaceuticals announced that the company’s TIME-2b study, a Phase IIb clinical trial designed to assess the efficacy and safety of its lead candidate, AKB-9778, for moderate to severe non-proliferative diabetic retinopathy didn’t meet the primary endpoint. Administration of AKB-9778 twice daily didn’t increase the percentage of patients with an improvement of two or more steps in the study eye’s diabetic retinopathy severity score compared with placebo. Read more.
Source: Aerpio Pharmaceuticals, March 2019
OXURION ENROLLS PATIENTS FOR PHASE II TRIAL EVALUATING COMBINATION OF ANTI-PLGF (THR-317) AND ANTI-VEGF (RANIBIZUMAB) FOR DME TREATMENT
Oxurion announced that all patients were enrolled in its Phase II trial evaluating its THR-317, a humanized antibody against placental growth factor, in combination with anti-VEGF (ranibizumab) for the treatment of diabetic macular edema. A total of 70 individuals were enrolled in the study. Topline data from the study are expected by the third quarter of 2019. Read more.
SOURCE: Oxurion, April 2019
STUDY: LIGHT THERAPY MIGHT HELP PREMATURE BABIES AVOID VISION PROBLEMS
Researchers at Cincinnati Children's Hospital Medical Center discovered a light-dependent molecular pathway that regulates how blood vessels develop in the eye. The findings in the April 1 online edition of Nature Cell Biology suggested that light therapy might help premature infants avoid vision problems. The novel molecular process called the opsin 5-dopamine pathway helps ensure blood-vessel development in the eye is appropriately balanced to prepare it for visual function. Researchers are looking for ways to prevent or treat retinopathy of prematurity and myopia in premature infants. Read more.
Source: Cincinnati Children's Hospital Medical Center, April 2019
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