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.
Phase I Study of OPT-302 inhibition of VEGF C and D for nAMD
A Phase I safety study of the drug OPT-302, sponsored by the drug’s maker Opthea (South Yarra, Australia) recently released some results. OPT-302 is a novel “trap” inhibitor of vascular endothelial growth factors C and D. In the study, researchers assessed the safety of intravitreal OPT-302 as monotherapy or combined with ranibizumab (Lucentis) in patients with neovascular age-related macular degeneration. The Phase I trial is designed to be open-label and dose escalating, followed by a randomized dose expansion.
Participants included 51 individuals with nAMD who were treatment-naïve (n=25) or previously treated with anti-VEGF-A therapy (n=26). In the dose escalation, groups of five patients in four cohorts received ascending doses of IVT OPT-302 (0.3, 1 or 2 mg) in combination with ranibizumab (0.5 mg), or as monotherapy (2 mg). In the dose expansion, 31 patients were randomized (3:1) to OPT-302 (2 mg) in combination with ranibizumab (n=23) or as monotherapy (n=8). All participants received IVT OPT-302 ± ranibizumab every four weeks (q4w) at days one, 29 and 57.
The primary outcome was safety. Other outcomes included OPT-302 pharmacokinetics (PK) and immunogenicity, need for anti-VEGF-A retreatment, effects on best-corrected visual acuity and anatomical changes. Here were some of the findings:
• OPT-302 with/without ranibizumab was well-tolerated with no dose-limiting toxicities.
• Systemic exposure following IVT OPT-302 was low, with no evidence of immunogenicity.
• In patients receiving OPT-302 monotherapy, 7/13 (54 percent) didn’t require rescue anti-VEGF-A therapy, and the mean change in BCVA from baseline to week 12 was +5.6 letters (range: 0 to 18).
• Increases in mean BCVA from baseline to week 12 were observed in patients administered combination OPT-302 + ranibizumab, with +10.8 letters (CI, 4 to 17; n=18) in treatment-naïve and +4.9 letters (CI 3, 7; n=19) in previously treated patients.
• Corresponding reductions in mean central subfield thickness at week 12 in both groups were -119 μm (CI -176 to -62) in treatment-naïve patients and -54 μm (CI, -82 to -26) in previously treated patients, while 50 percent of treatment-naïve patients also had no detectable choroidal neovascularization at week 12 on fluorescein angiography.
Researchers concluded that intravitreal OPT-302 inhibition of VEGF-C/-D was well-tolerated.
SOURCE: Dugel PU, Boyer DS, Antoszyk AN, et al. Phase 1 study of OPT-302 inhibition of vascular endothelial growth factors C and D for neovascular age-related macular degeneration. Ophthalmology Retina 2019; Oct. 23. [Epub ahead of print].
Ten-year Treatment Outcomes of nAMD From Two Regions
Investigators reported and compared 10-year treatment outcomes of vascular endothelial growth factor inhibitors for neovascular age-related macular degeneration from Australia and New Zealand (ANZ), and Switzerland, as part of a retrospective, comparative interventional case series.
They analyzed 712 treatment-naive eyes (ANZ eyes: 474; Swiss eyes: 321) starting anti-VEGF for nAMD in routine clinical practice between Jan. 1, 2006, and Dec. 31, 2008, and tracked in the prospectively designed observational database known as the Fight Retinal Blindness! Registry. The primary outcome was mean change in visual acuity (logMAR letters) in eyes that completed 10 years of treatment. Here were some of the findings:
• The mean VA in 132 eyes (28 percent) from ANZ completing 10 years of treatment dropped by 0.9 letters from baseline (CI, -4.9 to 3.1) (p=0.7), with 42 percent achieving ≥20/40; 37 eyes (12 percent) from Switzerland lost 14.9 letters (95% Confidence Interval: -24, -5.7) (p<0.001) with 35 percent achieving ≥20/40.
• ANZ eyes received more injections than Swiss eyes over 10 years (median of 53 vs. 42) from fewer visits with better disease control (percentage of visits with active disease: 38 percent vs. 69 percent), suggesting a treat-and-extend regimen vs. pro re nata.
• Macular atrophy and subretinal fibrosis were the main reasons for 10-letter loss in the subset of eyes retrospectively analyzed.
• The mean VA of all eyes discontinuing treatment within 10 years fell below baseline at the final visit.
Investigators found that nAMD eyes might achieve satisfactory long-term visual outcomes if they receive adequate treatment. They added that central macular atrophy didn’t develop universally in eyes on long-term treatment with VEGF inhibitors. Further, the investigators wrote, visual outcomes were better in ANZ eyes, likely because they received more injections.
SOURCE: Gillies M, Arnold J, Bhandari S, et al. Ten-year treatment outcomes of neovascular age-related macular degeneration from two regions. Am J Ophthalmol 2019; Oct 10. [Epub ahead of print].
Ranibizumab vs. Aflibercept for nAMD: Data from Fight Retinal Blindness! Registry
Researchers compared the three-year treatment outcomes of ranibizumab and aflibercept for the treatment of neovascular age-related macular degeneration in routine clinical practice. The retrospective analysis used data from the prospectively designed observational outcomes registry known as Fight Retinal Blindness! project.
Included were treatment-naïve eyes starting nAMD treatment from December 2013 to December 2015 with either ranibizumab or aflibercept that were tracked in the registry. Researchers analyzed visual acuity annually in completers (eyes of participants who completed three years of treatment) and in all eyes (completers, non-completers and eyes that switched treatment).
The primary outcome was a mean change in VA (number of letters read on a logMAR chart). A total of 965 eyes of 897 patients (ranibizumab: 499 eyes of 469 patients; aflibercept: 466 eyes of 432 patients) were identified. Here were some of the findings:
• The mean VA and the type of the choroidal neovascular lesion at the start of treatment was similar between the two groups.
• The group receiving ranibizumab was older.
• The crude mean VA change of +1.5 letters (CI, 0 to 3.1) in the ranibizumab group and +1.6 letters (CI, -0.2 to 3.3; p=0.97) in the aflibercept group at three years in all eyes was similar, as was the adjusted mean VA change: +0.3 (CI, -1.5 to 2) vs. +1 (CI, -0.7 to 2.8; p=0.66).
• Eyes of participants who completed three years of treatment in each of the groups received a median (Q1, Q3) of 18 (16, 22) injections for ranibizumab vs. 18 (15, 21; p=0.1) for aflibercept from a median of 21 (17, 25) vs. 21 (17, 26; p=0.25) clinical visits.
• The adjusted proportion of clinical visits during which the CNV was graded as active over three years was similar between ranibizumab (43 percent) and aflibercept (51 percent; p=0.9).
• There were more switches from ranibizumab to aflibercept (p<0.001) than vice versa.
• The proportion of eyes that didn’t complete three years of treatment in each of the groups was similar (p=0.21).
Researchers concluded that neither ranibizumab nor aflibercept was superior to the other in terms of VA outcomes and treatment frequency at three years for nAMD.
SOURCE: Bhandari S, Nguyen V, Arnold J, et al. Treatment outcomes of ranibizumab versus aflibercept for neovascular age-related macular degeneration: Data from the Fight Retinal Blindness! Registry. Ophthalmology 2019; Oct. 11 [Epub ahead of print].
Subretinal Drusenoid Deposits in AMD
Scientists clarified the role of subretinal drusenoid deposits (SDDs; pseudodrusen) in the progression of age-related macular degeneration through high-resolution histology.
They assessed examples of SDDs in contact with photoreceptors in 33 eyes of 32 donors (early AMD, n=15; geographic atrophy, n=9; neovascular AMD, n=7; unremarkable, n=2), and two eyes of two donors with in vivo multimodal imaging including optical coherence tomography. Here were some of the findings:
• SDDs were granular extracellular deposits at the apical retinal pigment epithelium; the smallest were 4-µm wide.
• Outer segment (OS) fragments and RPE organelles appeared in some larger deposits.
• A continuum of photoreceptor degeneration included OS disruption, intrusion into inner segments and disturbance of neurosensory retina.
• In transitioning to outer retinal atrophy, SDDs appeared to shrink, the OS disappeared, the inner segment shortened, and the outer nuclear layer thinned and became gliotic.
• Stage 1 SDDs on OCT correlated with displaced OS.
• Confluent and disintegrating stage 2 to 3 SDDs on OCT, and dot pseudodrusen by color fundus photography, correlated with confluent deposits and ectopic RPE.
Scientists determined that subretinal drusenoid deposits might start at the RPE as granular, extracellular deposits. They wrote that photoreceptor OS, RPE organelles and cell bodies might appear in some advanced deposits, and confirmed progression to atrophy associated with deposit diminution. They added that their findings supported a biogenesis hypothesis of outer retinal lipid cycling.
SOURCE: Chen L, Messinger JD, Zhang Y, et al. Subretinal drusenoid deposit in age-related macular degeneration: Histologic insights into initiation, progression to atrophy, and imaging. Retina 2019; Oct 9. [Epub ahead of print].
Cost-effectiveness of IVR vs. Panretinal Photocoagulation for PDR
Study authors wrote that the DRCR Retina Network Protocol S randomized clinical trial suggested that the mean visual acuity of eyes with proliferative diabetic retinopathy treated with ranibizumab wasn’t worse at five years than that of eyes treated with panretinal photocoagulation. They added that the ranibizumab group had fewer new cases of diabetic macular edema with vision loss or vitrectomy, but had four times the number of injections and three times the number of visits. Although two-year cost-effectiveness results of Protocol S were previously identified, incorporating five-year data from the study could alter the longer-term cost-effectiveness of the treatment strategies from the perspective of the health care system, the authors suggested.
Scientists evaluated 5- and 10-year cost-effectiveness of therapy with ranibizumab 0.5 mg compared with PRP for treating PDR. They initiated a preplanned secondary analysis of the Protocol S randomized clinical trial using efficacy, safety and resource utilization data through five years of follow-up for 213 adults diagnosed with PDR and simulated results through 10 years.
Interventions included intravitreous ranibizumab 0.5 mg at baseline and as frequently as every four weeks, based on a structured retreatment protocol vs. PRP at baseline for PDR; eyes in both groups could receive ranibizumab for concomitant DME with vision loss.
Scientists evaluated incremental cost-effectiveness ratios (ICERs) of ranibizumab therapy compared with PRP for those with and without center-involved DME (CI-DME) and vision loss (Snellen equivalent 20/32 or worse) at baseline. The study included 213 adults with a mean (SD) age of 53 (12) years, of whom 92 (43 percent) were women and 155 (73 percent) were white. Here were some of the findings:
• The ICER of the ranibizumab group compared with PRP for patients without CI-DME at baseline was $582,268 per quality-adjusted life-year (QALY) at five years, and $742,202/QALY at 10 years.
• For patients with baseline CI-DME, ICERs were $65,576/QALY at five years and $63,930/QALY at 10 years.
Scientists determined that, during five to 10 years of treatment, ranibizumab 0.5 mg as given in the studied trial compared with PRP may be within the frequently cited range considered cost-effective in the United States for PDR eyes with vision-impairing CI-DME, but not for PDR eyes without vision-impairing CI-DME. They added that substantial reductions in anti-vascular endothelial growth factor expense may make the ranibizumab therapy cost-effective within this range even for patients without baseline CI-DME.
SOURCE: Hutton DW, Stein JD, Glassman AR, et al. Five-year cost-effectiveness of intravitreous ranibizumab therapy vs panretinal photocoagulation for treating proliferative diabetic retinopathy: A secondary analysis of a randomized clinical trial. JAMA Ophthalmol 2019; Oct 24:1-9.
Natural History of DME & Factors Predicting Outcomes in Sham-treated Patients: MEAD Study
Scientists described the natural history of diabetic macular edema with respect to best-corrected visual acuity and central retinal thickness outcomes, and identified baseline patient characteristics and systemic factors associated with improvement or worsening of outcomes in sham-treated patients.
The study population was sham-treated patients (n=350) in the three-year MEAD registration study of dexamethasone intravitreal implant for treatment of DME. Patients had center-involved DME and received sham intravitreal injections in the study eye at intervals of six months or more. Scientists evaluated potential prognostic factors for outcomes using multiple linear regression analysis. Here were some of the findings:
• Visual and anatomic outcomes were poorer in patients who left the study early (n=198) than in study completers (n=152).
• Mean change in BCVA from baseline at the last visit with available data was +0.9 letters; 37.5 percent of patients had no change in BCVA, 23.2 percent had gained >10 letters and 16 percent lost >10 letters.
• Older age and baseline diabetic retinopathy score >6 were associated with worse BCVA outcomes.
• Thicker baseline CRT and larger number of hypertension medications used were associated with larger reductions in CRT during the study.
Scientists determined that BCVA and CRT outcomes were variable in this population of DME patients with generally good glycemic control. They found, in DME patients without active treatment, older age and baseline diabetic retinopathy score >6 were associated with less improvement in BCVA. Furthermore, the scientists determined that thicker baseline CRT and a larger number of antihypertensive medications used predicted better improvement in CRT.
SOURCE: Yoon YH, Boyer DS, Maturi RJ, et al. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study). Graefes Arch Clin Exp Ophthalmol 2019; Oct 25. [Epub ahead of print].
Using OCTA to Distinguish Intraretinal Microvascular Abnormalities from Retinal Neovascularization
Researchers evaluated the utility of optical coherence tomography angiography to characterize intraretinal microvascular abnormalities (IRMAs) and retinal neovascularization.
They imaged individuals with severe non-proliferative diabetic retinopathy or PDR with fluorescein angiography and widefield swept-source OCTA (Plex Elite 9000, Carl Zeiss Meditec). And they identified regions suspicious for IRMAs or retinal NV, and two masked readers graded the OCTA images, including flow overlay on the co-registered structural OCT and fluorescein angiography images. (Two of the study’s authors are consultants for Zeiss.)
Researchers analyzed 96 foci of irregular vasculatures, including 70 IRMAs and 26 retinal NV lesions from 14 eyes. Here were some of the findings:
• Compared with fluorescein angiography, OCTA with flow overlay demonstrated a specificity of 99 percent and sensitivity of 92 percent in identifying IRMAs and NV.
• Neovascularization differed from IRMAs on OCTA by demonstrating supraretinal flow breaching the internal limiting membrane and posterior hyaloid (p<0.001).
• IRMAs were distinguished from NV by outpouching of the internal limiting membrane (p=0.035).
• Vascular flow was reduced in the presence of fibrosis.
Researchers concluded that OCTA, through flow overlay, had utility in imaging and differentiating IRMA—a key feature distinguishing severe non-PDR; and NV—a key feature distinguishing PDR.
Source: Arya M, Sorour O, Chaudhri J, et al. Distinguishing intraretinal microvascular abnormalities from retinal neovascularization using optical coherence tomography angiography. Retina 2019; Oct 14. [Epub ahead of print].
Outcomes After Anti-VEGF for ME Due to CRVO or HRVO
Two-year outcomes were reported comparing eyes originally assigned to aflibercept or bevacizumab to assess the need for continued anti-vascular endothelial growth factor therapy for macular edema due to central retinal vein occlusion or hemiretinal vein occlusion from participants in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial.
Researchers evaluated outcomes one year after cessation of the SCORE2 treatment schedule. In the secondary analysis of the SCORE2 randomized clinical trial, follow-up included 117 participants originally randomized to aflibercept and 119 participants originally randomized to bevacizumab between Sept. 17, 2014, and Nov. 18, 2015. Data for the analyses were frozen on Sept. 13, 2018.
SCORE2 participants completed the treatment protocol at month 12, were subsequently treated at investigator discretion and underwent assessment at month 24. Main outcomes and measures included visual acuity letter score and central subfield thickness (CST) on spectral-domain optical coherence tomography. Here were some of the findings:
• Among 362 participants randomized to aflibercept or bevacizumab, 65.2 percent (236 of 362) completed a protocol visit at month 24 (mean [SD] age, 68.5 (12) years; 53.8 percent male).
• The mean (SD) visual acuity improved from baseline to 12 months by 21.6 (14.5) letters in the aflibercept group compared with 21.9 (16.6) letters in the bevacizumab group (difference, -0.3; 99 percent CI, -5.6 to 4.9), then worsened from those values by a mean (SD) of 7.6 (17.5) letters in the aflibercept group and 7.5 (14.5) letters in the bevacizumab group (difference, -0.1; 99 percent CI, -5.6 to 5.3) at month 24.
• The mean (SD) CST improved from baseline to 12 months by 394 (231) μm in the aflibercept group compared with 420 (274) μm in the bevacizumab group (difference: 26 μm; 99 percent CI, -62 to 114 μm), then worsened from those values by a mean (SD) of 58 (192) μm in the aflibercept group compared with 48 (186) μm in the bevacizumab group (difference: 10 μm; 99 percent CI, -58 to 78 μm) at month 24.
Researchers wrote that no differences in acuity or CST outcomes at month 24 were identified when participants originally assigned to aflibercept were compared with those assigned to bevacizumab. They added that caution in interpretation is needed because of loss to follow-up. In both groups, researchers wrote, visual acuity and CST improved through month 12 and then worsened somewhat during the second year, when treatment was left to the discretion of investigators. Researchers wrote further that this analysis suggested that CRVO and HRVO warrant close monitoring and treatment as needed over at least two years to optimize outcomes in eyes treated with anti-VEGF therapy.
Source: Scott IU, Oden NL, VanVeldhuisen PC, et al. Month 24 outcomes after treatment initiation with anti-vascular endothelial growth factor therapy for macular edema due to central retinal or hemiretinal vein occlusion: SCORE2 Report 10: A secondary analysis of the SCORE2 randomized clinical trial. JAMA Ophthalmol 2019; Oct 10. [Epub ahead of print].
Impact of Integrated Multiple Image Averaging on OCTA Image Quality and Quantitative Parameters
Investigators wrote that multiple image averaging (MIA) is a new approach that may improve OCT angiography imaging. They aimed to analyze the impact of MIA on image quality and quantitative OCTA parameters. They prospectively enrolled 20 eyes from 20 healthy volunteers (55.65 ±14.8 years). They performed imaging using two commercially available OCTA devices (Canon OCT HS-100 and the Optovue AngioVue) with a uniform imaging protocol. Each participant had two single scans of the macula (3 × 3 mm, Canon and Optovue) as well as five continuous single-scan imaging procedures (3 × 3 mm each) using the Canon device. Three out of five of these images with the highest quality were manually chosen and then automatically processed by the Canon device using MIA.
Investigators analyzed the superficial retinal plexus of the single scans and of MIA images with regard to the device’s own image quality scores (IQS), peak signal-to-noise ratio (PSNR), the size of the foveolar avascular zone (FAZ) and vessel density (VD). They recorded image acquisition times. And they compared the parameters between the devices and the different imaging protocols. Here were some of the findings:
• Average acquisition time was significantly higher for the MIA compared with the single measurements (29.09 ±10.19 seconds (MIA) vs. 5.56 ±2.17 seconds (Canon single scan) vs. 20.28 ± 6.81 seconds (Optovue) [p<0.001]).
• IQS showed no significant differences between the devices and between the recording protocols.
• PSNR was 12.38 ±0.20 (Canon single scan), 13.01 ±0.36 (Canon MIA) and 14.34 ±0.60 (Optovue) (p<0.001 between the groups).
• The mean FAZ area in Canon single scans was 0.29 ±0.06 mm2, 0.27 ±0.07 mm2 using MIA and 0.27 ± 0.08 mm2 using the Optovue device.
• No significant difference was found between mean FAZ measurements before and after averaging (Canon single scan vs. MIA, p=0.168).
• The VD of the parafoveal area using MIA was significantly lower compared with both single scans (p<0.001).
Investigators concluded that MIA could improve PSNR, but it also reduced imaging speed and significantly affected VD measurements. Therefore, they added that when comparing OCTA data, the use of uniform imaging protocols would be required.
SOURCE: Lauermann JL, Xu Y, Heiduschka P, et al. Impact of integrated multiple image averaging on OCT angiography image quality and quantitative parameters. Graefes Arch Clin Exp Ophthalmol 2019; Oct 19. [Epub ahead of print].
IVERIC’S NOVEL COMPLEMENT C5 INHIBITOR MEETS PRIMARY ENDPOINT
Iveric bio announced initial topline data confirming that Zimura (avacincaptad pegol), the company’s complement factor C5 inhibitor, met its prespecified primary endpoint in reducing the rate of geographic atrophy growth in patients with dry age-related macular degeneration, in a randomized, controlled Phase IIb clinical trial. The reduction in the mean rate of GA growth over 12 months was 27.38 percent (p=0.0072) for the Zimura 2 mg group compared with the sham control group and 27.81 percent (p=0.0051) for the Zimura 4 mg group when compared to the corresponding sham control group. Read more.
SOURCE: Iveric bio, October 2019
AERIE COMPLETES ENROLLMENT IN THE PHASE II TRIAL OF AR-1105
Aerie Pharmaceuticals announced that patient enrollment in its Phase II clinical trial of AR-1105 in patients with macular edema due to retinal vein occlusion was completed several weeks ahead of schedule. AR-1105 is an investigational sustained-release, bio-erodible intravitreal implant containing dexamethasone. The Phase II study, conducted at 19 centers in the United States, had an enrollment target of 45 patients. The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the implant. Safety and efficacy will be evaluated at six months. Read more.
SOURCE: Aerie Pharmaceuticals, October 2019
Adverum Doses First Patient in Third Cohort of OPTIC Phase I Trial of ADVM-022
Adverum Biotechnologies, announced that the first patient was dosed in the third cohort (n=9) of the ongoing OPTIC Phase I clinical trial for ADVM-022 for the treatment of neovascular age-related macular degeneration. Patients in this cohort are receiving a single intravitreal injection of gene therapy candidate ADVM-022 at a dose of 2 x 1011 vg/eye. Read more.
SOURCE: Adverum Biotechnologies, October 2019
EYEVENSYS PRESENTS DATA FROM PHASE I/II TRIAL OF GENE THERAPY
Eyevensys presented results from part one of its Phase I/II study of gene therapy for the treatment of non-infectious uveitis at the Ophthalmology Innovation Summit conference in San Francisco. The company’s technology is a non-viral gene therapy ocular drug delivery platform that uses a two-part electrotransfection system, including a proprietary Ocular Device and Electrical Pulse Generator that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle. This enables the ciliary muscle to produce the therapeutic protein that reaches the back of the eye, the company says. Read more.
SOURCE: Eyevensys, October 2019
PANOPTICA ANTI-VEGF DROP STUDIED IN NAMD TREATMENT
PanOptica reported positive clinical data for PAN-90806, a once-daily topical formulation of a small-molecule anti-vascular endothelial growth factor eye drop for the treatment of neovascular eye diseases. At the Ophthalmology Innovation Summit at the American Academy of Ophthalmology annual meeting, the company presented topline results from a Phase I/II dose-ranging clinical trial in which PAN-90806 demonstrated safety and biological response as monotherapy in treatment-naïve patients with neovascular age-related macular degeneration. Read more.
Source: PanOptica, October 2019
Data Validate the Target of Galimedix GAL-101
Galimedix Therapeutics announced that the recent positive results of a Phase III study in Alzheimer’s disease with Biogen’s aducanumab also validate the target of the company’s lead molecule, GAL-101, which targets the same amyloid beta pathology in dry macular degeneration and glaucoma using a topical drop. Aducanumab is an antibody that binds specifically to aggregated amyloid beta monomers, known as amyloid beta oligomers. A Phase II program in these two indications using GAL-101 is under development. Read more.
Source: Galimedix Therapeutics, October 2019
FDA ACCEPTS GENENTECH’S BIOLOGICS LICENSE APPLICATION FOR SATRALIZUMAB
Genentech, a member of the Roche Group, announced that the FDA has accepted the company’s Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, lifelong and debilitating autoimmune disease of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis. The European Medicines Agency (EMA) has also validated the company’s Marketing Authorization Application (MAA) for satralizumab, granting it Accelerated Assessment. The FDA decision and the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation are expected in 2020.
The satralizumab applications are based on positive results from two Phase III studies, SAkuraStar and SAkuraSky, evaluating the efficacy and safety of satralizumab as a monotherapy and in combination with baseline immunosuppressant therapy, respectively. Read more.
SOURCE: Genentech, October 2019
Cedars-Sinai to Test Stem Cells to Treat Eye Disease
Cedars-Sinai investigators have received funding to launch a clinical trial to test the safety of using stem-cell technology as a potential treatment for retinitis pigmentosa. The trial, approved by the FDA earlier this year and awarded $10.5 million by the California Institute for Regenerative Medicine, involves injecting a cortical progenitor cell product known as CNS10-NPC into the eye. In tests with laboratory animals, researchers showed that these injected cells migrated and formed a new layer of cells adjacent to the photoreceptor cells, slowed retinal degeneration and helped preserve vision. Read more.
Source: Cedars-Sinai, November 2019
BAUSCH HEALTH LICENSES CLEARSIDE BIOMEDICAL'S XIPERE
Bausch Health Companies announced that an affiliate of Bausch Health acquired an exclusive license for the commercialization and development of Xipere (triamcinolone acetonide suprachoroidal injectable suspension) in the United States and Canada. Xipere is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for suprachoroidal administration via Clearside's proprietary SCS Microinjector that’s being investigated as a targeted treatment of macular edema associated with uveitis. Read more.
SOURCE: Bausch Health Companies, October 2019
EYEVANCE PHARMACEUTICALS ACQUIRES TOBRADEX ST AND NATACYN
Eyevance Pharmaceuticals acquired two currently approved drugs from Novartis: Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05% and Natacyn (natamycin ophthalmic suspension) 5%. Tobradex ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05%, is a fixed-dose topical antibiotic and corticosteroid combination. Natacyn (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis and keratitis caused by susceptible organisms, including Fusarium solani
keratitis. Read more.
SOURCE: Eyevance Pharmaceuticals, October 2019
EYENUK RECEIVES NIH GRANT TO EXPAND AI EYE SCREENING PLATFORM
Eyenuk was awarded a grant to develop a fully automated retinal image artificial intelligence solution for detection of biomarkers for neurodegenerative disorders. The grant from the National Institute of Neurological Disorders and Stroke, a part of the National Institutes of Health, supports a collaboration between Eyenuk and Los Angeles’ Cedars-Sinai Medical Center to conduct research with the goal of developing ophthalmic screening tools for early detection of neurodegenerative disorders. Read more.
Source: Eyenuk, October 2019
NORLASE LAUNCHES SINGLE SPOT LASER
Norlase announced FDA approval of LEAF, the company’s laser therapy for the treatment of retinal disease and glaucoma. Norlase says that the device requires minimal set-up time and physical space: The entire laser unit attaches to an existing slit lamp. A wireless tablet serves as the user interface, and an optional voice control feature provides touchless parameter control during treatment. Read more.
Source: Norlase, October 2019
OPTOS UNVEILS SILVERSTONE
At the American Academy of Ophthalmology annual meeting in San Francisco, Optos launched Silverstone, an imaging system combining ultra-widefield retinal imaging with integrated, image-guided, swept-source optical coherence tomography. Silverstone produces a 200-degree, single-capture Optomap image with guided OCT, enabling OCT imaging anywhere across the retina, from posterior pole to far periphery, the company says. This provides UWF guided multimodal imaging in support of detection, investigation and monitoring of retinal disease. Read more.
SOURCE: Optos, October 2019
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