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.
Outcomes of Intravitreal Aflibercept for nAMD Using a Treat-and-extend Regimen
Investigators evaluated outcomes in individuals with neovascular age-related macular degeneration after treatment with aflibercept for up to four years using a treat-and-extend regimen, as part of an observational study.
Participants included people with newly diagnosed nAMD treated with aflibercept in a treat-and-extend protocol. Subjects received three injections of aflibercept at monthly intervals followed by a treat-and-extend protocol for at least 12 months. At each clinical visit after the loading phase, optical coherence tomography and best-corrected visual acuity testing were performed to monitor disease activity.
The main outcome measures included change in BCVA over time, the number of injections and visits per year, and the percentage of individuals reaching a treatment interval of ≥12 weeks. Of 231 consecutive eyes (231 individuals) with a mean follow-up time of 2.9 (1 to 5.5) years, 173 were followed for ≥2 years, 112 for ≥3 years and 62 for ≥4 years. Some of the findings include:
• Mean BCVA increased from 59.8 letters (20/60) at diagnosis to 65.8 letters (20/50) after the loading phase (+6 ±11.1 letters) and to 65.5 letters at 12 months (+5.7 ± 17 letters).
• After four years of treatment, mean BCVA was maintained insignificantly better than baseline (mean: 63.4 letters; gain: +3.6 ±20.6 letters; p>0.05).
To achieve this response, a mean of 7.7 ±1.2 injections and 4.4 ±1.6 clinic visits in the first year, and 4.4 ±1.9 injections and 4.3 ±1.3 clinic visits per year thereafter were required. By two years of follow-up, 46.9 percent of individuals reached a treatment interval of ≥12 weeks.
Investigators determined that individuals with nAMD maintained stable visual function over four years in a real-world setting with a reasonable treatment burden using the treat-and-extend regimen.
SOURCE: Traine PG, Pfister IB, Zandi S, et al. Long-term outcome of intravitreal aflibercept treatment for neovascular age-related macular degeneration using a "treat-and-extend“ regimen. Ophthalmology Retina 2019; Feb. 1. [Epub ahead of print].
Genetics of Large PED in nAMD
Researchers hypothesized that severe forms of neovascular age-related macular degeneration such as large pigment epithelial detachments poorly responding to anti-vascular endothelial growth factor therapy might present a distinct genotype compared with an overall series of neovascular AMD.
In the multicenter genetic association study, 68 individuals presenting with PEDs resistant to ranibizumab (issued from the ARI2 study) were compared with two series of individuals derived from previously published clinical studies, presenting neovascular AMD (NAT2 study n=300 and PHRC study n=1,127) and with healthy controls (n=441). The phenotype of nAMD groups was based on visual acuity measurement, fundus examination, spectral-domain optical coherence tomography and angiographic data. All samples were genotyped for three single-nucleotide polymorphisms: CFH (rs1061170); ARMS2 (rs10490924); and C3 (rs2230199). Significant differences in allele frequency between participants with neovascular AMD and control was the main outcome measurement. Here were some of the findings:
• The GG genotype of the C3 rs2230199 was significantly more frequent in the ARI2 group (55.9 percent) than the PHRC group (6 percent, p<0.0001; OR=24 [CI, 10.4 to 55]) and the NAT2 group (5.1 percent, p<0.0001; OR=16.1 [CI, 5 to 51.9]).
• The repartition of individuals carrying a T allele of the ARMS2 (rs10490924) or patients carrying a C allele of the CFH (rs1061170) was similar in the ARI2 group when compared with the NAT2 and PHRC groups.
Researchers wrote that the genotype GG of C3 rs2230199 was more significantly associated with the phenotype of large vascularized PED poorly responding to anti-VEGF therapy than with a global AMD series.
SOURCE: Mouallem-Beziere A, Blanco-Garavito R, Richard F, et al. Genetics of large pigment epithelial detachments in neovascular age-related macular degeneration. Retina 2019; Jan 23. [Epub ahead of print].
CNV Activity by OCT Location & Quantifying of Abnormal Fluid with Anti-VEGF for AMD
Investigators assessed optical coherence tomography leakage to help identify and quantify choroidal neovascularization-related fluid and changes after anti-vascular endothelial growth factor therapy in neovascular age-related macular degeneration eyes.
The prospective analysis of nAMD cases treated with 2 mg intravitreal aflibercept included eyes examined before, and one week and one month after a single injection. Investigators assessed best-corrected visual acuity using the Early Treatment Diabetic Retinopathy Study method. They acquired OCT leakage maps depicting low optical reflectivity (LOR) sites with OCT Cirrus AngioPlex, and correlated the LOR area ratio to retinal thickness and BCVA. Twenty-two eyes of 18 individuals with nAMD were included. Here are some of the findings:
• The LOR ratio of full retina scans and retinal pigment epithelium Bruch’s layers decreased from baseline to month one (p<0.05).
• Changes in retinal thickness and LOR ratio were positively correlated (p<0.05).
• BCVA correlated with outer segment layer LOR changes (rho=-0.53; p=0.014), and LOR was inferior in better responders (p=0.021).
• OCT leakage helped identify eyes with recurrent fluid in the external layers.
Investigators wrote that OCT leakage helped identify and quantify fluid related to CNV activity, that low optical reflectivity changes in outer segment layers correlated with functional outcomes and that increasing LOR in the external layers might be a marker of early recurrence. They suggested that combining OCT angiography and OCT leakage images enabled CNV morphology and activity analysis.
SOURCE: Farinha C, Santos T, Santos AR, et al. Optical coherence tomography leakage in neovascular age-related macular degeneration: Identification of choroidal neovascularization activity by location and quantification of abnormal fluid under anti-vascular endothelial growth factor therapy. Retina 2018; Jan. 24. [Epub ahead of print].
Correlations Between Choriocapillaris Flow Deficits Around GA and Enlargement Rates Based on SS-OCT Imaging
Investigators determined the possible correlation between the annual enlargement rates (ERs) of geographic atrophy with the percentage and size of the choriocapillaris (CC) flow deficits (FDs) surrounding GA, measured with swept-source optical coherence tomography angiography images, as part of a prospective, observational case series.
Participants included individuals with GA secondary to non-exudative AMD. Individuals were imaged with a 100-kHz SS-OCTA instrument (PLEX Elite 9000, Carl Zeiss Meditec) using a 6x6 mm field of view scan pattern. GA area measurements were obtained from en face SS-OCT sub-RPE slab images. Visualization of the CC and quantification of FDs were performed using a previously validated algorithm based on a 20-micron thick slab with the inner boundary located beneath Bruch’s membrane. Investigators calculated percentage of CC FDs (FD%) and the average FD area measurements in different regions around the GA.
Main outcome measures included the correlation between CC FDs and the ERs of GA. Twenty-two eyes from 15 individuals were eligible for analysis. Here are some of the findings:
• The annual square root ERs for GA ranged from 0.07 to 0.75 mm/year.
• The CC FD% and average FD area measurements were highly correlated with each other (p<0.001), with the highest FD values found in the region closest to the margin of GA.
• The ERs correlated best with the average CC FD area measurements in the total scan area minus the area of GA (Pearson r=0.747; p<0.001) than with those in the regions immediately surrounding the GA (r=0.544; p=0.009).
Investigators wrote that, contrary to expectations, global CC FD measurements had a better correlation with the ERs of GA than those in the regions immediately around the GA. They suggested that the most likely explanation for this outcome was that normal age-related increases in FDs within the central macula confounded the correlations between the ERs of GA and FDs, while the regions farthest from the margins of GA were less affected by normal age-related changes and reflected FD alterations related to AMD severity.
SOURCE: Thulliez M, Zhang Q, Shi Y, et al. Correlations between choriocapillaris flow deficits around geographic atrophy and enlargement rates based on swept source OCT Imaging. Ophthalmology Retina 2019; Feb. 6. [Epub ahead of print].
ARMS2 A69S Polymorphism Associated with Delayed Rod-mediated Dark Adaptation in Eyes at Risk for Incident AMD
Researchers examined the association between sequence variants in genetic risk factors for age-related macular degeneration and delayed rod-mediated dark adaptation in older adults with normal macular health and early AMD, as part of a cross-sectional study. One of the researchers holds the patent on the dark adaptation device used in the study.
Participants included adults 60 years of age or older showing normal macular health (defined as both eyes at step 1 on the Age-Related Eye Disease Study nine-step AMD classification system) and those with AMD in one or both eyes (defined as steps 2 through 9).
Researchers genotyped single nucleotide polymorphisms in the complement factor H (CFH) and ARMS2 genes using a Taqman assay. They assessed rod-mediated dark adaptation in one eye after photobleach, with targets centered at 5 degrees on the inferior vertical meridian. Rate of dark adaptation was defined by rod intercept time (RIT), duration (in minutes) required for sensitivity to reach a criterion sensitivity level in the latter half of the second component of rod recovery. Researchers adjusted associations between CFH and ARMS2 polymorphisms and RMDA for age and smoking. The main outcome measure was RIT.
The sample consisted of 543 participants having genotype and RIT determination; 408 showed normal macular health and 135 demonstrated AMD, most having early AMD (124 of 135). Here were some of the findings:
• For the combined sample, higher RIT (slower RMDA) was observed for the A69S variant in ARMS2 (adjusted p=0.0001) and the Y402H variant in CFH (adjusted p=0.0023).
• For healthy participants, the A69S variant in ARMS2 was associated with higher RIT (adjusted p=0.0011), while the Y402H variant in CFH wasn’t (adjusted p=0.2175).
• For AMD patients, the A69S variant of ARMS2 (adjusted p=0.0182) and the Y402H variant of CFH (adjusted p=0.0222) were associated with higher RIT.
• Those with a larger number of high-risk ARMS2 and CFH alleles showed higher RIT, in healthy (adjusted p=0.0002) and AMD groups (adjusted p<0.0001).
Researchers say they found a novel association in which older adults with high-risk ARMS2 and CFH genotypes were more likely to demonstrate delayed RMDA, which they say is a functional biomarker for incident early AMD. Researchers add that understanding ARMS2 function should be a research priority.
Source: Mullins RF, McGwin G Jr, Searcey K, et al. The ARMS2 A69S polymorphism is associated with delayed rod-mediated dark adaptation in eyes at risk for incident age-related macular degeneration. Ophthalmology 2018; Oct. 31. [Epub ahead of print].
OCT-based Diagnostic Criteria for Myopic Maculopathy Staging
Scientists evaluated whether distance vision impairment (VI) (LogMAR) >0.30), or near VI (NVI) (logMAR 0.32 to 1.30 at 40 cm with <0.30 at 3 m) independently predicted health-related quality of life (HRQoL), and estimated its societal impact.
The National Eye Survey of Trinidad and Tobago was a population-based, cross-sectional eye survey using multistage, cluster random sampling with probability-proportionate-to-size methods in adults aged >40 years.
Responders rated general health level in the five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) of the EQ-5D 5-level instrument. Multivariable regression analyses with robust standard error estimation explored the relationship between utility score and presenting vision. The main outcome measure included utility value and Quality Adjusted Life Year (QALY) loss by vision category. A total of 62.4 percent (2,658/4,263) of adults queried completed the EQ-5D-5L. Mean age was 58.4 (SD 11.8, range 40 to 103) years and 56.3 percent were female. Here are some of the findings:
• Blindness had the largest independent effect on utility coefficient, at -0.140 (CI, -0.092 to -0.192), with a mean utility value of 0.727 (CI, 0.671 to 0.784), and a mean EQ-VAS score of 69.9 (CI, 62.0 to 77.8).
• Near VI was also independently associated with utility loss of -0.012 (CI, 0.004 to -0.021).
• Independent predictors of utility <1 included female sex, older age, being uninsured, lower educational attainment, ethnicity and multiple medical co-morbidities.
• A hypothetical person, experiencing onset of a stable vision state at 40 years, would be expected to accrue lifetime loss of 0.45 QALYs for near VI, 0.72 QALYs for mild VI, 1.64 QALYs for moderate VI, 3.30 QALYs for severe VI and 5.13 QALYs for blindness.
• VI caused 762.3 QALYs lost per 100,000 population per year, of which 36.5 percent were attributed to near VI, exceeding the equivalent QALY loss from stroke (307 QALYs), depression (284 QALYs) or arthritis (522 QALYs).
• Ninety-one percent (694.9/762.3) of VI-related QALY loss was potentially avoidable.
Scientists reported that this was the first population-based survey to identify that both distance and near VI independently reduced HRQoL. They wrote that the estimated QALY loss highlighted the societal importance of efforts to address all degrees of avoidable VI.
SOURCE: Braithwaite T, Bailey H, Bartholomew D, et al. Impact of vision loss on health-related quality of life in Trinidad and Tobago. Ophthalmology 2019; Jan 28. [Epub ahead of print].
Anti-VEGF Therapy for Persistent Neovascularization Following Complete Panretinal Photocoagulation in PDR
Scientists reported the short-term efficacy and safety of intravitreal bevacizumab (Avastin) injections with panretinal laser photocoagulation in individuals with high-risk proliferative diabetic retinopathy, according to the Early Treatment Diabetic Retinopathy Study criteria.
A prospective, interventional case series study was conducted on 17 individuals (20 eyes) with high-risk PDR who were treated with intravitreal bevacizumab (2.5 mg) followed by PRP when the peripheral vitreous became clear or two weeks after injection. Individuals underwent complete ophthalmic evaluations, including Snellen visual acuity and fluorescein angiography at baseline, one, three and six months after bevacizumab injection. Main outcome measures included serial changes in visual acuity, vitreous clear-up time and neovascularization on the disc (NVD) regression time. Here are some of the findings:
• All individuals had obvious reduction in angiographic leakage and involution of retinal neovascularization (NV) at the one- and three-month follow-up.
• The mean follow-up time was 7.5 months. The vitreous hemorrhage (VH) showed a partial resolution as early as one week, and complete regression at three months.
• The mean vitreous clear-up time after intravitreal Avastin was 8.5 ±2.2 weeks.
• The mean time interval from intravitreal Avastin to NVD regression was 10.8 ±3.4 weeks.
• Mean logMAR visual acuity improved from 1.03 at baseline, to 0.36 at one-month, 0.38 at three-month and 0.48 at six-month follow-ups (p<0.01).
• Three eyes (18 percent) required vitrectomy surgery during follow-up. The indication for vitrectomy was dense, persistent VH in two eyes and focal tractional retinal detachment (TRD) in one eye.
• Recurrent retinal NV with minor preretinal hemorrhage was observed in six eyes (30 percent) three months after the first injection and resolved after repeated bevacizumab injections.
• Individuals received an average of 1.4 injections (range: 1 to 2). Seven eyes (35 percent) underwent two injections.
• One eye (5 percent) experienced the progression of PDR to a TRD.
• No systemic adverse events were observed following injections.
Scientists found that short-term results suggested combined intravitreal bevacizumab and PRP achieved rapid clearance of VH, regression of retinal NV and visual improvement in the treatment of high-risk PDR. They added that long-term study was warranted to assess the long-term efficacy and safety.
SOURCE: Mehanna C-J, Fattah MA, Haddad S, et al. Anti-VEGF therapy for persistent neovascularization following complete panretinal photocoagulation in proliferative diabetic retinopathy. Ophthalmology Retina 2018; Feb. 8. [Epub ahead of print].
Blood Pressure is Associated with Receiving Intravitreal Anti-VEGF Treatment in Diabetic Patients
This study aimed to identify factors associated with receiving intravitreal anti-vascular endothelial growth factor injections and the number of treatments received in an 18-month period in diabetics, as part of a retrospective cohort study.
Subjects included 2,916 patients with diabetes who presented to the Kellogg Eye Center Retina Clinic from June 1, 2016, to Dec. 31, 2017. Researchers retrospectively analyzed data collected from diabetic individuals who presented to the clinic. Logistic regression was used to identify demographic and medical factors associated with receiving at least one injection. Negative binomial regression was used to model the number of anti-VEGF injections. Main outcome measures included receipt of at least one anti-VEGF injection and number of anti-VEGF injections received during the study period. Here were some of the findings:
• Systolic blood pressure and diagnosis of diabetic retinopathy were significantly associated with receiving an injection.
• A history of kidney disease was positively associated with the number of injections received.
• Type 1 diabetes was negatively associated with receiving an injection and the number of injections.
• Current hemoglobin A1c wasn’t associated with receiving an injection or number of injections.
Researches said that tthat current glycemic control wasn’t significantly associated with outcome measures. Researchers wrote that this study was the first to report on such associations, implying that factors that confer risk for DR development might not be the same as those that confer risk for treatment.
SOURCE: Shah AR, Van Horn AN, Verchinina L, et al. Blood pressure is associated with receiving intravitreal anti-vascular endothelial growth factor treatment in patients with diabetes. Ophthalmology Retina 2019; Feb. 2. [Epub ahead of print].
Immune Response in Leber Hereditary Optic Neuropathy Treated With Recombinant Adeno-associated Virus 2 Carrying the ND4 Gene
Investigators examined the association between immune response and intraocular inflammation after ocular gene therapy with recombinant adeno-associated virus 2 carrying the ND4 gene (rAAV2/2-ND4).
The secondary analysis of an open-label, dose-escalation Phase I/II randomized clinical trial of rAAV2/2-ND4 included data from February 13, 2014, to March 30, 2017—the first two years after injection. Individuals older than 15 years with diagnosed ND4 Leber hereditary optic neuropathy and visual acuity of at least counting fingers were enrolled in one of five cohorts. Four dose cohorts of three individuals each were treated sequentially. Individuals received increasing doses of rAAV2/2-ND4 (9 × 109, 3 × 1,010, 9 × 1,010 and 1.8 × 1,011 viral genomes per eye) as a single, unilateral intravitreal injection. An extension cohort of three individuals received the dose of 9 × 1,010 viral genomes per eye.
Individuals were monitored for 96 weeks after injection; ocular exams were performed regularly, and blood samples were collected for immunologic testing.
A composite ocular inflammation score was based on grades of anterior chamber cells and flare, vitreous cells and haze according to the Standardization of Uveitis Nomenclature. The systemic immune response was quantified by enzyme-linked immunospot (cellular immune response), enzyme-linked immunosorbent assay (IgG titers) and luciferase assay (neutralizing antibody [NAb] titers). The analysis included 15 individuals (mean age: 47.9 ±17.2 years; 13 men and two women) enrolled in the five cohorts of the clinical trial. The following were some of the results:
• Thirteen individuals experienced intraocular inflammation after rAAV2/2-ND4 administration.
• Mild anterior chamber inflammation and vitritis were reported at all doses, but all cases were responsive to treatment.
• A maximum OIS of 9.5 was observed in an individual with a history of idiopathic uveitis.
• Overall, OIS wasn’t associated with the viral dose administered.
• No NAbs against AAV2 were detected in aqueous humor before treatment.
• Two individuals tested positive for cellular immune response against AAV2 at baseline and after treatment.
• Humoral immune response wasn’t apparently associated with the dose administered or with the immune status of individuals at baseline.
• No association was found between OISs and serum NAb titers.
Investigators wrote that intravitreal administration of rAAV2/2-ND4 in individuals with LHON was safe and well-tolerated. They added that further investigation might shed light on the local immune response to rAAV2/2-ND4 as a potential explanation for observed intraocular inflammation.
SOURCE: Bouquet C, Vignal Clermont C, Galy A, et al. Immune response and intraocular inflammation in patients with Leber Hereditary Optic Neuropathy treated with intravitreal injection of recombinant adeno-associated virus 2 carrying the nd4 gene: A secondary analysis of a phase 1/2 clinical trial. JAMA Ophthalmol 2019; Feb 7. [Epub ahead of print].
Longitudinal Changes in Eyes With Hydroxychloroquine Retinal Toxicity
Researchers characterized functional and structural changes in eyes with hydroxychloroquine retinal toxicity after drug cessation.
Twenty-two individuals (91 percent female; mean age: 58.7 ±11.4 years; mean duration of HCQ treatment: 161.1 ±90 months; mean dose: 5.9 ±1.9 mg/kg) with detected HCQ retinopathy were monitored for six to 82 months after HCQ cessation with multimodal imaging including spectral-domain optical coherence tomography and fundus autofluorescence imaging at 488 nm (standard) and 787 nm (near-infrared).
Tests of visual function, including visual acuity, Humphrey visual fields and multifocal electroretinography, were performed. Researchers categorized study eyes into four severity stages by qualitative grading of SD-OCT macular scans taken at the time of HCQ cessation. Changes in outcome measures between drug cessation and last follow-up visit were computed and compared between eyes of different severity stages.
Researchers categorized study eyes (n=44) based on OCT criteria into: Stage 1 (subtle changes confined to parafoveal region; n=14); Stage 2 (clear, localized changes in parafovea; n=17); Stage 3 (extensive parafoveal changes; n=7); and Stage 4 (foveal involvement; n=6). Here are some of the findings:
• Visual acuity measurements across follow-up were stable in Stage 1 and Stage 2 eyes but decreased significantly in Stage 3 and 4 eyes.
• Humphrey VF measures were also stable in stages 1 and 2 but deteriorated in Stage 3 eyes.
• mfERG testing demonstrated significant improvement in the R1/R2 ratio after HCQ cessation in Stage 1 eyes (mean change = -0.86 ±0.79, p=0.03) but didn’t change significantly in eyes of higher stages.
• Decreases in macular thickness in at least one of nine Early Treatment Diabetic Retinopathy Study subfields on SD-OCT were found in eyes of all stages, with Stage 2 eyes demonstrating thinning in most subfields (eight of nine subfields).
• In eyes with a measurable central foveal ellipsoid zone band island (nine of the 17 Stage 2 eyes, and all seven Stage 3 eyes), a progressive decrease in the foveal ellipsoid zone band length was observed in six of nine Stage 2 eyes (67 percent), and 6 of 7 Stage 3 eyes (86 percent).
• Changes indicative of progressing retinopathy were detected in 17 percent of Stage 1 eyes, 46 percent of Stage 2 eyes and 43 percent of Stage 3 eyes on standard fundus autofluorescence imaging; and in 17 percent of Stage 1 eyes, 38 percent of Stage 2 eyes and 14 percent of Stage 3 eyes on near-infrared autofluorescence imaging.
Researchers reported that eyes with detected HCQ retinopathy didn’t demonstrate general stability in retinal structure and function after HCQ cessation but rather demonstrated a range of changes during follow-up whose magnitudes correlated with retinopathy severity at the time of cessation. They wrote that, after cessation, eyes with only subtle and localized retinopathy were mostly stable and potentially showed some functional improvement, while more severely affected eyes continued to progress. Moreover, researchers added, these findings provide evidence that early detection and prompt cessation in HCQ retinopathy might be needed to arrest retinopathy progression and optimize long-term outcomes.
SOURCE: Allahdina, AM, Chen KG, Alvarez JA, Wong WT, et al. Longitudinal changes in eyes with hydroxychloroquine retinal toxicity. Retina 2019; Feb. 5. [Epub ahead of print].
GRAYBUG ANNOUNCES POSITIVE TOP-LINE RESULTS FOR ADAGIO STUDY
Graybug Vision announced positive top-line results for the ADAGIO study, a Phase I/IIa study of intravitreal GB-102 (sunitinib malate) in individuals with wet age-related macular degeneration. The study met the primary endpoints of safety and tolerability without dose-limiting toxicities, drug-related serious adverse events or inflammation. Secondary outcomes demonstrated evidence of stability and maintenance of visual acuity and central retinal thickness that was durable over at least six-months as measured by eye chart readings and optical coherence tomography. Planning for the GB-102 Phase IIb clinical study is under way, and enrollment is expected to begin in 2019. Read more.
SOURCE: Graybug Vision, January 2019
LUTRONIC INITIATES PRECLINICAL TRIAL OF R:GEN LASER FOR TREATMENT OF DRY AMD
Lutronic Vision announced it initiated a preclinical trial to determine the optimal setting for its R:Gen laser to treat dry age-related macular degeneration. The company says it’s aiming to bring to market its fully integrated laser platform designed to target the retinal pigment epithelium to regenerate and restore its function. Read more.
Source: Lutronic Vision, January 2019
First Patient Dosed in Ocular Therapeutix OTX-TKI (tyrosine kinase inhibitor implant) Phase I Trial
Ocular Therapeutix announced the dosing of the first patient at Australia’s Sydney Retina Clinic, in a Phase I trial of OTX-TKI (tyrosine kinase inhibitor implant) in individuals with wet age-related macular degeneration. The multicenter, open-label study is testing the safety, durability and tolerability of OTX-TKI, a bioresorbable hydrogel fiber implant formulated with a tyrosine kinase inhibitor delivered by intravitreal injection to individuals with wet AMD. The study will evaluate biological activity by measuring retinal thickness using optical coherence tomography and following visual acuity over time. Read more.
Source: Ocular Therapeutix, February 2019
Clearside’s XIPERE Begins FDA Review; PEACHTREE EXTENSION STUDY EXHIBITS DURABILITY FOLLOWING SECOND DOSE
Clearside Biomedical received notification from the FDA that the agency will be reviewing the company’s New Drug Application for XIPERE (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection for the treatment of macular edema associated with uveitis. The Prescription Drug User Fee Act goal date (by which time the FDA has to render a decision) has been assigned for Oct. 19. The NDA filing is supported by data from the Phase III PEACHTREE clinical trial, which the company says demonstrated significant and clinically meaningful improvement in vision for patients with macular edema associated with non-infectious uveitis, and that improvement was achieved across all anatomical locations of uveitis. Read more.
In addition, the company announced that data from MAGNOLIA, an extension study of PEACHTREE, revealed that half of XIPERE-treated subjects maintained efficacy through 36 additional weeks after their second suprachoroidal injection of XIPERE, without requiring additional treatment. The most common adverse events seen in the trial included cataracts and increases in intraocular pressure consistent with previous trials of XIPERE. No serious adverse events were reported. Read more.
SOURCE: Clearside Biomedical, February and January 2019
NEUROTECH GRANTED FAST TRACK DESIGNATION FOR MACTEL TYPE 2 TREATMENT
Neurotech Pharmaceuticals announced that the FDA granted Fast Track designation for the company's development candidate, NT-501 (Renexus), for the treatment of macular telangiectasia type 2. Fast Track is a designation intended to facilitate development and expedite review of drugs that treat serious or life-threatening conditions and fill an unmet medical need. In a multicenter, randomized, controlled, Phase II clinical study of the drug in the treatment of MacTel, Renexus slowed progression of retinal degeneration compared with sham treatment. Read more.
SOURCE: Neurotech Pharmaceuticals, February 2019
SPECTRALIS OCT2 MODULE AIDS INTERNATIONAL SPACE STATION
Heidelberg Engineering announced that its Spectralis imaging platform with next-generation OCT2 Module that was delivered to the International Space Station back in May 2018 is now operational. The company says the new imaging platform, placed into service in late December 2018, is designed to provide a faster scan speed with more sensitive signal detection to enhance image quality and preserve the resolution when scanning the inner retina. In addition, TruTrack Active Eye Tracking was designed to help reduce variability between exams. Read more.
SOURCE: Heidelberg Engineering, February 2019
PR3VENT COMPLETES SERIES A FINANCING LED BY INFOCUS CAPITAL
Pr3vent, a health-care AI company developing technology for detecting eye disease in newborns, closed a Series A financing round led by InFocus Capital Partners. Pr3vent’s screening tool is the first AI-based system designed to protect against vision loss in babies, the company says. The technology detects abnormality from noninvasive images of the infant’s retina with an algorithm that identifies pathology. Read more.
SOURCE: Pr3vent, February 2019
B+L LAUNCHES SIGHTMATTERS.COM TO HELP PEOPLE WITH AMD
Bausch + Lomb announced the launch of SightMatters.com, an educational online resource for people living with age-related macular degeneration, in conjunction with the start of AMD Awareness Month. B+L says that the resource, which was designed for the visually impaired with an increased font size and distinctive color contrast between different elements in the site, will help individuals take charge of their condition by offering a singular resource that is clear, concise and offers actionable content. Visitors will have the opportunity to join a supportive online community of people living with AMD, the company adds. Read more.
SOURCE: Bausch + Lomb, February 2019
JANSSEN & MEIRAGTX TO DEVELOP GENE THERAPIES FOR INHERITED RETINAL DISEASES
The Janssen Pharmaceutical Companies of Johnson & Johnson announced a worldwide collaboration and license agreement with MeiraGTx Holdings to develop, manufacture and commercialize its clinical-stage inherited retinal disease portfolio, including leading product candidates for achromatopsia caused by mutations in CNGB3 or CNGA3, and X-linked retinitis pigmentosa. The companies also have formed a research collaboration to explore targets for other inherited retinal diseases and develop adeno-associated virus manufacturing technology. Read more.
Source: Janssen Pharmaceutical Companies, January 2019
Roche Enters into Definitive Merger Agreement to Acquire Spark Therapeutics
Roche and Spark Therapeutics announced that they entered into a definitive merger agreement for Roche to fully acquire Spark for approximately $4.3 billion. Spark Therapeutics was the first company to receive FDA approval for a gene therapy for a genetic disease in 2017, Luxturna (voretigene neparvovec-rzyl). Luxturna is a one-time gene therapy product indicated for the treatment of individuals with confirmed biallelic RPE65 mutation-associated retinal dystrophy, and the drug is marketed by Spark. The company is also developing SPK-1001 for CLN2 disease (a form of Batten disease) as well as additional preclinical programs for Stargardt’s disease. Read more.
Source: Roche, February 2019
EYENUK PROVIDES AI EYE SCREENING TO THOUSANDS OF ITALIANS
Eyenuk provided EyeArt AI eye screenings throughout Italy as part of the Month of Prevention of Diabetic Retinopathy and Maculopathy in February. The EyeArt AI Eye Screening System is designed to make it possible for a physician to quickly and accurately detect referable DR patients in less than a minute during a diabetic patient’s regular exam. Read more.
Source: Eyenuk, February 2019
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