Volume 13, Number 1
January 2017

WELCOME to Review of Ophthalmology's Retina Online e-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.

Genentech announced that the U.S. Food and Drug Administration approved Lucentis (ranibizumab injection) 0.5 mg for the treatment of individuals with myopic choroidal neovascularization, making it the first FDA-approved anti-vascular endothelial growth factor therapy to treat mCNV in the United States...


Allegro Ophthalmics completed enrollment in the second stage of its DEL MAR trial evaluating the safety and efficacy of Luminate in combination and as an adjunctive therapy with anti-VEGFs in individuals with diabetic macular edema...

And More...


OCTA Changes in Early Type 3 Neovascularization After Anti-VEGF

Researchers examined morphologic changes on optical coherence tomography angiography of treatment-naive type 3 neovascularization secondary to exudative age-related macular degeneration after one year of anti-vascular endothelial growth factor therapy.

Researchers enrolled consecutive individuals diagnosed with treatment-naive early-stage type 3 neovascularization in the retrospective study. All individuals underwent color fundus photographs/MultiColor (Heidelberg Engineering) imaging, fluorescein angiography, indocyanine green angiography, structural spectral-domain OCT and OCTA Optovue RTVue XR Avanti (Optovue) at baseline, and repeated OCTA and structural SD-OCT at month 12. Researchers then compared qualitative analysis of the 3 x 3 OCTA exams at baseline and month 12 to assess changes after anti-VEGF therapy.

A total of 15 treatment-naive eyes of 15 consecutive individuals were included in the analysis. At 12-month follow-up after pro re nata anti-VEGF therapy (5.75 ±1.48 injections of ranibizumab and injections of 6.33 ±1.21 of aflibercept), OCTA demonstrated persistence of the deep capillary plexus abnormalities in 13 of 15 eyes. In the outer retina and choriocapillaris, the initial lesion became undetectable in seven of 15 cases, accompanied by choriocapillaris atrophy. The abnormal vascular complex persisted in the form of a tuft-shaped lesion in the outer retinal segmentation in nine of 15 eyes, which in the choriocapillaris segmentation was associated with subretinal pigment epithelium neovascularization in eight cases.

Researchers noted that, after one year of anti-vascular endothelial growth factor therapy, the tuft-shaped abnormal outer retinal lesion seen on OCTA—frequently associated with a small, clew-like flow signal in the choriocapillaris—either became undetectable or developed sub-retinal pigment epithelium neovascularization.

SOURCE: Miere A, Querques G, Semoun O, et al. Optical coherence tomography angiography changes in early type 3 neovascularization after anti-vascular endothelial growth factor treatment. Retina 2017; Jan 10. [Epub ahead of print].



Switching to Aflibercept for Treatment-resistant Neovascular AMD

Scientists systematically reviewed anatomical and functional outcomes subsequent to switching from bevacizumab/ranibizumab to aflibercept monotherapy (Eylea; Bayer/Regeneron) in individuals with treatment-resistant neovascular age-related macular degeneration, as part of a systematic review and meta-analysis. One of the researchers is a consultant for Bayer.

The researchers searched Medline, PubMed, Embase and Cochrane databases up to July 2016 for available scientific literature that met inclusion criteria. Eligible studies reported visual and anatomical outcomes with at least six months of follow-up among individuals with nAMD and persistent or resistant exudative fluid despite previous anti-vascular endothelial growth factor therapy (bevacizumab and/or ranibizumab) and were switched to aflibercept monotherapy. Mean changes in best-corrected visual acuity and central retinal thickness were pooled using random-effects models with CIs.

Of 82 papers reviewed, 28 studies met inclusion criteria of this review. Pooled results showed a small mean improvement in BCVA at six and 12 months following switching (1.11 letters: CI, 0.25 to 2.46; p=0.17; and 0.63 letters: CI, -0.26 to 1.52; p=0.17, respectively). There was a significant improvement in mean CRT following switching (-61.90 µm: CI, -77.10 to -46.80; p<0.001; and -50.00 µm: CI -63.20 to -36.80; p<0.001 at six and 12 months, respectively).

Pooled analysis demonstrated significantly improved anatomical outcomes, although visual function remained stable with a comparable effect to other anti-VEGF agents in preservation of vision. Scientists wrote that, given the fact that subjects had poorly responsive chronic disease with limited potential for visual recovery, switching to aflibercept with frequent monitoring might be a suitable option for individuals who have developed treatment resistance.

SOURCE: Spooner K, Hong T, Wijeyakumar W, et al. Switching to aflibercept among patients with treatment-resistant neovascular age-related macular degeneration: A systematic review with meta-analysis. Clin Ophthalmol 2017;11:161-7.

Short-term Safety of 2 Mg Intravitreal Ziv-Aflibercept

Researchers assessed the safety of single intravitreal 2 mg ziv-aflibercept (0.08 mL) injections for the treatment of choroidal neovascular membranes.

Eyes with choroidal neovascular membranes received single intravitreal injections of 2 mg ziv-aflibercept (0.08 mL). Comprehensive ophthalmic exams and detailed systemic evaluations were performed at baseline and days one, seven and 30 after injections. Standard electroretinography was performed at baseline and day 30. Primary outcome measures consisted of safety assessments (signs of clinical toxicity and electroretinographic abnormalities). Secondary outcome measures included changes in best-corrected visual acuity and central subfield thickness of the macula.

Twenty-one eyes of 20 individuals (12 males) received injections. Etiologies responsible for the choroidal neovascular membranes included: age-related macular degeneration (14), polypoidal choroidal vasculopathy (3), myopia (2) and idiopathic juxtafoveal telangiectasia (2). No individuals complained of worsening vision or pain after the intravitreal injections, and no intraocular inflammation was seen. No significant changes in the electroretinographic b/a ratio from baseline to one month were measured (scotopic: p=0.89; photopic: p=0.13), and mean intraocular pressures were unchanged (14.2 ±3.6 vs. 13.7 ±3 mmHg; p=0.62). Mean BCVA didn’t change significantly from baseline to one month (0.66 ±0.37 logMAR [Snellen equivalent: 20/100] vs. 0.61 ±0.35 logMAR [Snellen equivalent: 20/80]; p=0.72) but significant improvements in central subfield thickness were seen (343 ±177 vs. 210 ±133 µm; p=0.01).

Researchers wrote that single intravitreal injections of 2 mg ziv-aflibercept (0.08 mL) appeared to be safe through one month.

SOURCE: Chhablani J, Dedhia CJ, Peguda HK, et al. Short-term safety of 2 mg intravitreal ziv-aflibercept. Retina 2017; Jan 2. [Epub ahead of print].

ENDURANCE 12-Month Extension Study: As-needed Aflibercept & Macular Laser

Researchers determined whether the efficacy and safety achieved with 2 mg intravitreal aflibercept injections for diabetic macular edema during the phase III VISTA DME trial were maintained with individualized, as-needed treatment, as part of a Phase IV, multicenter, open-label extension study.

Sixty individuals completing VISTA DME elected to enter the ENDURANCE extension study. All individuals received IAIs in the presence of clinically relevant DME and were observed at four-, eight- or 12-week intervals depending on the need for treatment. Main outcome measures were mean IAIs given through month 12, the proportion of individuals receiving no IAIs and the role of macular laser in decreasing treatment burden among individuals requiring ongoing IAIs.

A mean of 4.5 IAIs were administered through month 12. Eighteen (30 percent) individuals required no IAIs, and among those who met IAI retreatment criteria, a mean of 6 IAIs were administered through month 12. Best-corrected visual acuity gains achieved during VISTA DME were maintained and stable, with individualized dosing during ENDURANCE fluctuating by a mean of <1.5 letters from the baseline at all time points. Likewise, mean central retinal thickness remained relatively stable during ENDURANCE. Thirty-seven (62 percent) individuals met macular laser criteria at a mean of 19.5 weeks, with no significant difference in the frequency of IAIs before or after macular laser.

Researchers determined that vision gains achieved during the three-year VISTA DME trial were maintained through month 12 of the ENDURANCE extension study with a reduced treatment frequency, with 30 percent of individuals receiving no IAIs. They observed no significant reduction in IAI frequency after macular laser application.

SOURCE: Wykoff CC, Le RT, Khurana RN, et al. Outcomes with as-needed aflibercept and macular laser following the Phase III VISTA DME trial: ENDURANCE 12-month extension study. Am J Ophthalmol 2017;173:56-63.

Long-term Effects of Intravitreal 0.19 mg Fluocinolone Acetonide Implant on DR Progression & Regression

Researchers examined the effects of fluocinolone acetonide on the progression to proliferative diabetic retinopathy, and the impact of FAc on changes in the Early Treatment Diabetic Retinopathy Study diabetic retinopathy severity scale grade during the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) A and B Phase III clinical trials.

The post hoc analysis of data from the 36-month prospective, randomized, FAME A and B trials included individuals with diabetic macular edema who received sham control or FAc 0.2 or 0.5 μg/day.

A masked reading center from the University of Wisconsin-Madison determined DRSS grade using standard 7-field stereo fundus photography and retinal perfusion status using fluorescein angiography. Retinopathy changes over time were determined by DRSS step differences from baseline to month 36. Pairwise comparisons between the three treatment groups were performed using a log-rank test without adjustment for covariates, with the primary comparison between sham control and 0.2 μg/day FAc.

Main outcome measures included study-eye progression to PDR based on a composite clinical outcome of: progression from nonproliferative diabetic retinopathy to PDR based on graded fundus photographs; panretinal photocoagulation or pars plana vitrectomy for PDR; and study eye changes on the DRSS.

In the integrated FAME data set, compared with sham control-treated subjects, time to first PDR event was significantly delayed in subjects treated with FAc (p<0.001), and this effect was confirmed in subgroups with more severe DR and chronic DME at baseline. In addition, subjects with retinal nonperfusion at baseline showed greater reduction in progression to PDR with FAc treatment. Both FAc dosages demonstrated statistically significant improvements in mean DR severity compared with sham treatment at months six, 12 and 18. More subjects who received FAc experienced two-or-more- or three-or-more-step improvements in DR severity compared with subjects who received sham; conversely, fewer subjects treated with FAc experienced two-or-more- or three-or-more-step worsening in DR severity. The three-or-more-step improvement with 0.5 μg/day FAc was statistically significantly different from sham control.

Scientists determined that, in subjects with DME, sustained intraocular delivery of FAc slowed development of PDR and progression of diabetic retinopathy.

SOURCE: Wykoff CC, Chakravarthy U, Campochiaro PA, et al. Long-term effects of intravitreal 0.19 mg fluocinolone acetonide implant on progression and regression of diabetic retinopathy. Ophthalmology 2017; Jan. 9. [Epub ahead of print].

Review of Automated DR Image Assessment Software

Researchers wrote that automated diabetic retinopathy image assessment systems (ARIAS) may provide clinically effective and cost-effective detection of retinopathy. They aimed to determine whether ARIAS can be safely introduced into DR screening pathways to replace human graders, as part of an observational measurement comparison study of human graders following a national screening program for DR vs. ARIAS.

Researchers included retinal images from 20,258 consecutive individuals attending routine annual diabetic eye screening between June 1, 2012, and November 4, 2013.

They manually graded retinal images following a standard national protocol for DR screening and processed them with by iGradingM, Retmarker and EyeArt. They sent discrepancies between manual grades and ARIAS results to a reading center for arbitration.

Main outcome measures included screening performance (sensitivity, false-positive rate) and diagnostic accuracy (CI, screening-performance measures). Economic analysis estimated the cost per appropriate screening outcome.

Researchers noted the following sensitivity point estimates (CI) of the ARIAS. For EyeArt, they were: 94.7 percent (94.2 to 95.2 percent) for any retinopathy; 93.8 percent (92.9 to 94.6 percent) for referable retinopathy (human graded as either ungradable, maculopathy, preproliferative or proliferative); 99.6 percent (97 to 99.9 percent) for proliferative retinopathy. For Retmarker, they were: 73 percent (72 to 74 percent) for any retinopathy; 85 percent (83.6 to 86.2 percent) for referable retinopathy; 97.9 percent (94.9 to 99.1 percent) for proliferative retinopathy. iGradingM classified all images as either having disease or being ungradable. EyeArt and Retmarker saved costs compared with manual grading as a replacement for initial human grading and as a filter prior to primary human grading, although the latter approach was less cost-effective.

Researchers concluded that Retmarker and EyeArt systems achieved acceptable sensitivity for referable retinopathy when compared with that of human graders, and had sufficient specificity to make them cost-effective alternatives to manual grading alone. They added that ARIAS have the potential to reduce health-care costs and aid delivery of DR screening in developing or remote health-care settings.

SOURCE: Tufail A, Rudisill C, Egan C, et al. Automated diabetic retinopathy image assessment software: Diagnostic accuracy and cost-effectiveness compared with human graders. Ophthalmology 2016; Dec 23. [Epub ahead of print].

Type 2 Diabetes Genetic Variants & Risk of DR

Investigators wrote that genetic association studies to date have not identified any robust risk loci for diabetic retinopathy. They hypothesized that individuals with more diabetes genetic risk alleles had a higher risk of developing DR, as part of a case-control genetic association study.

Investigators evaluated the aggregate effects of multiple type 2 diabetes-associated genetic variants on the risk of DR among 1,528 participants with diabetes from the Singapore Epidemiology of Eye Diseases Study. A total of 547 (35.8 percent) had DR.

Participants underwent a comprehensive ocular exam including dilated fundus photography. Investigators graded retinal photographs using the modified Airlie House classification system to assess the presence and severity of DR following a standardized protocol. They identified 76 previously discovered type 2 diabetes-associated single nucleotide polymorphisms, and constructed multilocus genetic risk scores for each individual by summing the number of risk alleles for each SNP weighted by the respective effect estimates on DR. They generated two GRSs: an overall GRS including all 76 discovered type 2 diabetes-associated SNPs, and an Asian-specific GRS that included a subset of 55 SNPs previously found to be associated with type 2 diabetes in East and/or South Asian ancestry populations. Associations between the GRSs with DR were determined using logistic regression analyses. Investigators determined the discriminating ability of the GRSs by the area under the receiver operating characteristic curve. The main outcome measure included the odds ratios on DR.

Participants in the top tertile of the overall GRS were 2.56-fold more likely to have DR compared with participants in the lowest tertile. Participants in the top tertile of the Asian-specific GRS were twofold more likely to have DR compared with participants in the bottom tertile. Both GRSs were associated with higher DR severity levels; however, addition of the GRSs to traditional risk factors improved the AUC modestly—by 3 to 4 percent.

Investigators concluded that type 2 diabetes-associated genetic loci were significantly associated with higher risks of DR, independent of traditional risk factors.

SOURCE: Chong YH, Fan Q, Tham YC, et al. Type 2 diabetes genetic variants and risk of diabetic retinopathy. Ophthalmology 2016; Dec 27. [Epub ahead of print].

Factors Influencing Acute Central Serous Chorioretinopathy Episode Duration

Scientists looked at the influence of clinical and multimodal imaging parameters on the duration of acute central serous chorioretinopathy episodes.

They prospectively included consecutive individuals with first, treatment-naive central serous chorioretinopathy episodes presenting within 20 days of symptoms onset, and reevaluated them 15 days to 20 days later, followed by monthly evaluation for six months. Scientists analyzed the following; subfoveal choroidal thickness; fluorescein leakage intensity on fluorescein angiography; elevation of retinal pigment epithelium lesions at leakage sites; focal/multifocal pattern of indocyanine green angiography at baseline; time-dependent pattern of subretinal fluid resorption on OCT using volume segmentation; history of corticosteroid intake; and mean blood pressure using univariate (Log rank test) and multivariate (Cox proportional hazard regression) survival analysis.

Of 31 participants (26 men, five women, mean age: 40 ±8.9 years, range: 24 to 58), 26 (84 percent) had episode resolution by six months. Using univariate analysis, episode duration was longer in cases with subfoveal choroidal thickness ≥500 µm (p=0.0002), retinal pigment epithelium elevation at leakage sites ≥50 µm (p=0.033) and a peak in subretinal fluid observed during follow-up (p=0.013). Scientists determined a near-significant association of intense fluorescein leakage (p=0.074) with longer episodes. Using multivariate analysis, subfoveal choroidal thickness ≥500 µm (p=0.017), RPE elevation at leakage sites ≥50 µm (p=0.010) and participant age ≥40 years (p=0.010) were significantly and independently associated with longer episodes. Indocyanine green angiography pattern, corticosteroid intake and blood pressure didn’t influence episode duration.

Scientists concluded that older age, higher subfoveal choroidal thickness and higher degree of RPE alteration at leakage sites were independent factors for longer acute central serous chorioretinopathy episodes.

SOURCE: Daruich A, Matet A, Marchionno L, et al. Acute central serous chorioretinopathy: Factors influencing episode duration. Retina 2017; Jan 6. [Epub ahead of print].

Macular Pigment Response to Zeaxanthin Supplementation in Macular Telangiectasia Type 2

Investigators analyzed macular pigment amount and distribution in individuals with macular telangiectasia type 2 receiving oral zeaxanthin supplementation, in a randomized, open-label, interventional trial.

Eight individuals with macular telangiectasia type 2 were randomized to 10 mg or 20 mg of zeaxanthin per day. At each visit, best-corrected visual acuity, contrast sensitivity, fundus biomicroscopy, color fundus photography, autofluorescence imaging, optical coherence tomography and serum carotenoid levels were tested. Individuals were assessed at baseline and after six, 12, 18 and 24 months of zeaxanthin supplementation. Investigators analyzed and calculated concentration of MP from autofluorescence imaging obtained at 488-nm excitation wavelength. High-performance liquid chromatography provided serum carotenoid levels.

The majority of individuals had definite increases in the intensity of hypofluorescent ring of MP, with none depositing MP centrally at the fovea. Although some individuals noted subjective improvements in vision, no objective improvements could be documented, and no changes could be seen in foveal OCT features. Yellowish, hypofluorescent crystals appeared in one individual's macular region, yielding no change in visual acuity. These inner retinal crystals disappeared several months after discontinuing a 20-mg zeaxanthin supplement.

Investigators determined that zeaxanthin supplementation didn’t result in any visual benefit in individuals with macular telangiectasia type 2 and did not reestablish a normal peaked distribution of MP in the fovea. Furthermore, they found, one individual developed a novel, reversible, crystalline maculopathy in response to zeaxanthin supplementation that was reminiscent of canthaxanthin crystalline maculopathy.

SOURCE: Choi RY, Gorusupudi A, Wegner K, et al. Macular pigment distribution responses to high-dose zeaxanthin supplementation in patients with macular telangiectasia type 2. Retina 2017; Jan 10. [Epub ahead of print].

Surgical Outcomes of 27-Gauge Vitrectomy for Various Vitreous Diseases

Investigators evaluated the safety and efficacy of 27-ga. vitrectomy for various vitreoretinal disorders, as part of a retrospective, comparative study.

A total of 163 consecutive eyes with various diseases underwent 27-ga. pars plana vitrectomy with or without ultraspeed transformer (which enables high cutting and aspiration rates) by a single surgeon from June 2012 through December 2014. Investigators analyzed the eyes for best-corrected visual acuity, intraocular pressure, intraoperative and postoperative complications, and surgery time.

In two eyes (1.2 percent), peripheral retina breaks were encountered intraoperatively, yet no other complications were found in those eyes. No cases required larger-gauge vitrectomy. Mean BCVA improved from 20/58 (logMAR: 0.46 ±0.64) preoperatively to 20/32 (LogMAR: 0.20 ±0.40) postoperatively (p<0.001). Mean follow-up was 16.7 months (range: 6 to 33 months). Intraocular pressure remained stable throughout the postoperative course. Hypotony was seen in 15 eyes (9.2 percent) at one-day postoperative, yet that spontaneously improved within one week. No case of retinal detachment or endophthalmitis was recorded. In macular surgeries, such as idiopathic epiretinal membrane and macular hole combined with cataract surgery, mean surgery time was 32.1 ±6.9 minutes with ultraspeed transformer (n=38) and 37.1 ±7.7 minutes without ultraspeed transformer (n=40) (p=0.004).

Investigators found the 27-ga. pars plana vitrectomy to be safe and effective for treating various vitreoretinal disorders.

SOURCE: Yoneda K, Morikawa K, Oshima Y, et al. Surgical outcomes of 27-gauge vitrectomy for a consecutive series of 163 eyes with various vitreous diseases. Retina 2017; Jan 4. [Epub ahead of print].



Genentech announced that the U.S. Food and Drug Administration approved Lucentis (ranibizumab injection) 0.5 mg for the treatment of individuals with myopic choroidal neovascularization, making it the first FDA-approved anti-vascular endothelial growth factor therapy to treat mCNV in the United States. This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared with verteporfin photodynamic therapy. At three months, average VA gains for individuals treated with Lucentis were more than 12 letters, compared with 1.4 letters for those treated with vPDT. RADIANCE is a Phase III, randomized, double-masked, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) vs. vPDT in 276 patients with visual impairment due to mCNV. Subjects were randomized into three treatment groups. Two groups randomized to Lucentis received injections guided by pre-specified retreatment criteria and the third group received treatment with vPDT. At month three, the Lucentis groups I and II had a mean change in best-corrected visual acuity of +12.1 and +12.5 letters from baseline, respectively, demonstrating a statistically significant improvement over the vPDT group III, which had a mean BCVA change of +1.4 letters from baseline. The efficacy between groups I and II were comparable. Adverse events were similar to those seen in other Lucentis trials. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006. Read more.

Source: Genentech, January 2017


Allegro Ophthalmics completed enrollment in the second stage of its DEL MAR trial evaluating the safety and efficacy of Luminate in combination and as an adjunctive therapy with anti-VEGFs in individuals with diabetic macular edema. Topline results from the DEL MAR Stage I monotherapy trial in which Luminate met its primary and secondary endpoints, demonstrating equivalence to bevacizumab monotherapy with half the number of injections, were released in October. DEL MAR Stage II is a double- masked, placebo-controlled, randomized, multicenter, five-month Phase IIb trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate 0.5 mg or 1 mg in combination with bevacizumab 1.25 mg and as an adjunctive therapy after treatment with a single treatment with bevacizumab 1.25 mg in patients with DME. Read more.

Source: Allegro Ophthalmics, December 2017

ThromboGenics Enrolls First Patients in Phase II Study Evaluating THR-317 for DME

ThromboGenics NV enrolled the first patients in a Phase II, single-masked, multicenter exploratory study evaluating the safety and efficacy of two dose levels of THR-317 for the treatment of diabetic macular edema. THR-317 (anti-PIGF) is a recombinant human monoclonal antibody directed against the receptor-binding site of human placental growth factor. The study will evaluate the safety of three intravitreal injections of two dose levels of THR-317 (4 mg or 8 mg). The trial will also assess THR-317's ability to improve best-corrected visual acuity and to reduce central retinal thickness in subjects with DME. The study plans to enroll a total of 50 patients over a period of about 12 months. The first results from the study are expected in the first quarter of 2018. Read more.

Source: ThromboGenics, January 2017


Nikon and its subsidiary Optos announced a strategic alliance with Verily Life Sciences in the field of machine learning-enabled retinal imaging. The companies will collaborate on creating technology and solutions for enhanced screening of diabetic retinopathy and diabetic macular edema. The partnership will combine Nikon's leadership in optical engineering and precision manufacturing, its proprietary ultra-widefield technology and strong commercial presence among eyecare specialists, and Verily’s machine learning technology. Read more. 

Source: Nikon Corp., December 2016

4D Molecular Enrolls First Patient in Study to Develop Gene Therapy for Choroideremia

4D Molecular Therapeutics enrolled the first participant in its Choroideremia Natural History Study to develop a gene therapy product optimized for intravitreal administration to treat choroideremia. 4DMT deployed its proprietary AAV vector discovery platform, Therapeutic Vector Evolution, to create and optimize a proprietary AAV vector for intravitreal delivery to the retina. This vector is designated to be the basis for the first 4DMT experimental gene therapeutic targeted for the treatment of CHM. 4DMT is working closely with the Choroideremia Research Foundation on CHM product development and the Natural History Study.

Source: 4D Molecular Therapeutics, January 2017

GenSight Reports Sustained VA Gain in Phase I/II Study of GS010

GenSight Biologics reported additional promising results after 78 weeks of follow-up in its Phase I/II clinical trial. These results confirm the favorable safety and tolerability profile of GS010 while demonstrating sustainable visual acuity improvement in patients with Leber’s Hereditary Optic Neuropathy. Each cohort of three subjects was administered an increasing dose of GS010 through a single intravitreal injection in the eye most severely affected by the disease. Recruitment was completed in April 2015, and long-term follow-up is ongoing. Read more.

Source: GenSight Biologics, December 2016

Acucela Receives FDA Orphan Drug Designation to Treat Stargardt’s Disease

Acucela announced the U.S. Food and Drug Administration granted orphan drug designation to its leading drug candidate, emixustat hydrochloride, for the treatment of Stargardt’s disease. The Orphan Drug Act provides for granting special status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States. In animal models of Stargardt’s disease and retinal degeneration, emixustat was found to stop and reverse the accumulation of A2E and to preserve the integrity of the retina. Emixustat, when delivered orally, was found to be generally well-tolerated in human clinical studies, with delayed dark adaptation being the most common ocular adverse event. Read more.

Source: Acucela Inc., January 2017

LKC Technologies' RETeval Electrodiagnostic Device & Sensor Strips Earn Two U.S. Patents

LKC Technologies’ RETeval device, a flash ERG/VEP system, was granted a patent in November 2016, for its exclusive stimulus generation, and another patent in December 2016, for its LKC Sensor Strip skin electrode arrays. The products enable physicians and researchers to better utilize visual electrophysiology to evaluate retina function through the assessment, diagnosis and monitoring of a variety of vision-threatening diseases such as glaucoma and diabetic retinopathy. Read more.

Source: LKC Technologies, January 2017

Lin Licenses Dry AMD Therapeutic Program from Columbia University in Collaboration with NIH

Lin Bioscience and Columbia Technology Ventures announced that Lin Bioscience licensed the intellectual property portfolio and development program for a promising first-in-class medication intended to slow or halt the progression of atrophic dry age-related macular degeneration. Under the terms of the licensing agreement and collaboration model, the National Institute of Health's Blueprint Neurotherapeutics Network, which has funded the medication's discovery and development, will continue to provide financial support through Phase I, and will continue to collaborate with Columbia University and Lin Bioscience. LBS-008 is an oral therapeutic candidate that works by reducing retinol in circulation and excess retinal uptake leading to the formation of toxic byproducts that build up under the retina, contributing to dry AMD and Stargardt’s disease. LBS-008 is expected to enter Phase I clinical trials in 2017 for dry AMD, as well as for Stargardt’s disease as an orphan indication. Read more.

Source: Columbia University, January 2017

Nova Oculus & StarFish Partner for Manufacturing

Nova Oculus Partners and StarFish Medical announced a collaborative agreement to bring to market a pioneering medical device for the treatment of age-related macular degeneration. The agreement makes StarFish responsible for the development and manufacturing of the Nova Oculus headset, an integral component of the electrotherapeutic medical device that Nova Oculus designed to treat individuals with AMD. StarFish, a Canadian company, has earned ISO-13485 certification from the International Organization of Standardization. StarFish is expected to begin mass producing the device by spring 2017. The Nova Oculus device is going through clinical patient trials in Canada, with regulatory approval for full market commercialization expected there by mid-2017. Read more.

Source: Nova Oculus Partners, January 2017


Steven J. Gedde, MD, professor of ophthalmology at Bascom Palmer Eye Institute of the University of Miami, was awarded the 2016 Straatsma Award for Excellence in Resident Education at the annual meeting of the American Academy of Ophthalmology in Chicago. During his 17 years as director for Bascom Palmer’s residency program, the residency has consistently ranked as the nation’s top ophthalmology training program in peer surveys. As well, graduating residents have achieved a pass rate of 100 percent in the exams given by the American Board of Ophthalmology. Holder of the John G. Clarkson Chair in Ophthalmology, which supports medical education at Bascom Palmer, Dr. Gedde is the Institute’s vice chair of education. He has received numerous awards for his commitment to education, including the Department of Ophthalmology’s “Professor of the Year” in 1998 and 2003, the “First Year Teaching Award” in 2000, “Resident Teaching Award” in 2011 and South Florida’s Excellence in Health Care Educator of the Year. Read more.

Source: University of Miami MillerSchool of Medicine, January 2017


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