Review of Ophthalmology's Retina Online


Volume 14, Number 8
August 2018

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.

FDA Approves Eylea Injection SBLA In Wet AMD
Regeneron recently announced that the U.S. FDA has approved a supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection in individuals with wet age-related macular degeneration...

AI Equal to Experts in Detecting Eye Diseases
Researchers from UCL, DeepMind Health and Moorfields Eye Hospital NHS Foundation Trust developed an artificial intelligence system that can recommend the correct referral decision for more than 50 eye diseases as accurately as experts...

And More...

Ranibizumab Induces DR Regression in Most Cases at High Risk of PDR Progression

Researchers evaluated diabetic retinopathy outcomes with ranibizumab (Lucentis, Genentech) treatment in individuals with DR and diabetic macular edema at high risk of progression to proliferative disease, as part of a post hoc analysis of the Phase III RIDE and RISE clinical trials of ranibizumab for the treatment of DME.

A total of 746 individuals with baseline fundus photographs were randomized for treatment. Researchers assessed DR outcomes through month 36 by baseline DR severity level. They quantified DR severity using the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale. Main outcome measures included two-step or more, or three-step or more, improvements or worsening on the ETDRS DRSS and time to new proliferative event (composite end point). Researchers reported the following findings.
• At baseline, most individuals were distributed evenly among mild or moderate nonproliferative DR (ETDRS DRSS, 35/43; 28.8 percent), moderately severe or severe NPDR (ETDRS DRSS, 47/53; 33.2 percent), and proliferative DR (ETDRS DRSS, 60 to 75; 31.1 percent).
• At month 24, rates of two-step or more improvement with ranibizumab 0.3 mg (78.4 percent), ranibizumab 0.5 mg (81.1 percent) and sham treatment (11.6 percent) were highest among individuals with baseline DR levels 47/53 compared with individuals with baseline DR levels 35/43 (ranibizumab 0.3 mg, [10.3 percent], ranibizumab 0.5 mg [15.8 percent] and sham treatment [1.4 percent]); or 60 to 75 without panretinal photocoagulation (ranibizumab 0.3 mg [31 percent], ranibizumab 0.5 mg [36.4 percent] and sham treatment [6.7 percent]; all ranibizumab vs. sham comparisons, p<0.05).
• In individuals with baseline DR levels 47/53, ranibizumab treatment reduced the probability of individuals experiencing a new proliferative event at month 36 by three times compared with sham treatment (ranibizumab 0.3 mg [12.4 percent] and ranibizumab 0.5 mg [11.9 percent] and sham [35.2 percent]).
• In individuals with baseline DR levels 47/53 who achieved two-step or more DR improvement, improvements were independent of all assessed baseline characteristics (p>0.4).

Researchers concluded that ranibizumab treatments resulted in DR improvements in all three baseline DR severity subsets examined. They added that the greatest benefits in DR improvement occurred in individuals with baseline moderately severe to severe NPDR (DR levels 47/53), and that DR improvements were rapid, clinically meaningful and sustained through month 36.

SOURCE: Wykoff CC, Eichenbaum DA, Roth DB, et al. Ranibizumab induces regression of diabetic retinopathy in most patients at high risk of progression to proliferative diabetic retinopathy. Ophthalmology Retina 2018; Aug. 1. [Epub ahead of print].


Panretinal Photocoagulation vs. Intravitreous Ranibizumab for PDR

Investigators evaluated the efficacy and safety of 0.5-mg intravitreous ranibizumab vs. panretinal photocoagulation over five years for proliferative diabetic retinopathy. They evaluated 394 study eyes in the Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial with PDR, enrolled February through December 2012.

Eyes were randomly assigned to receive intravitreous ranibizumab (n=191) or PRP (n=203). The frequency of ranibizumab was based on a protocol-specified retreatment algorithm. Diabetic macular edema could be managed with ranibizumab in either group. The main outcome was mean change in visual acuity (intention-to-treat analysis). Secondary outcomes included peripheral visual field loss, development of vision-impairing DME and ocular and systemic safety.

The five-year visit was completed by 184 of 277 participants (66 percent excluding deaths). Of 305 enrolled participants, the mean (SD) age was 52 (12) years; 135 (44 percent) were women and 160 (52 percent) were white.

For the ranibizumab and PRP groups, respectively:
• the mean (SD) number of injections over five years was 19.2 (10.9) and 5.4 (7.9);
• the mean (SD) change in VA letter score was 3.1 (14.3) and three (10.5) letters (adjusted difference, 0.6; CI, -2.3 to 3.5; p=0.68);
• the mean VA was 20/25 (approximate Snellen equivalent) in both groups at five years; and
• the mean (SD) change in cumulative VF total point score was -330 (645) (n=41) vs. -527 (635) dB (n=38) groups (adjusted difference, 208 dB; CI, 9 to 408);
• vision-impairing DME developed in 27 vs. 53 eyes (cumulative probabilities: 22 percent vs. 38 percent; HR, 0.4; CI, 0.3 to 0.7); and
• there were no statistically significant differences between groups in terms of major systemic adverse event rates.

Investigators wrote that, although loss to follow-up was relatively high, VA in most study eyes that completed follow-up was very good at five years and similar in both groups. They added that severe vision loss or serious PDR complications were uncommon with PRP or ranibizumab; however, the ranibizumab group had lower rates of developing vision-impairing DME and less VF loss. Lastly, they wrote that the findings supported anti-vascular endothelial growth factor therapy or PRP as viable treatments for PDR. Investigators suggested that clinicians should consider patient-specific factors—including anticipated visit compliance, cost and frequency of visits—when choosing treatment for individuals with PDR.

SOURCE: Gross JG, Glassman AR, Liu D, et al. Five-year outcomes of panretinal photocoagulation vs. intravitreous ranibizumab for proliferative diabetic retinopathy: A randomized clinical trial. JAMA Ophthalmol 2018; Jul 24. [Epub ahead of print].



Anti-VEGF Therapy in DME: Real-world Outcomes

Researchers assessed real-world visual acuity outcomes of anti-vascular endothelial growth factor therapy for diabetic macular edema. They performed a retrospective analysis on the Vestrum Health Retina Database of aggregated, longitudinal electronic medical records from a geographically and demographically diverse sample of cases of U.S. retina specialists.

Participants included DME eyes that underwent ≥3 monthly anti-VEGF injections within four months of the first injection (between January 2011 and March 2017) with follow-up data prior to March 2018.

The eyes were divided into three groups based on initial intravitreal anti-VEGF agents (aflibercept, bevacizumab or ranibizumab). These eyes were subdivided into three cohorts by length of follow-up (six, 12 or 24 months), with each cohort being mutually exclusive. Researchers assessed VA outcomes and number of treatments on each cohort, and stratified the results by baseline VA. A total of 15,608 DME eyes were included.

In the 12-month cohort, of 1,379 eyes initially treated with aflibercept:
• the mean 12-month improvement was +5.5 letters (CI, +4.5 to +6.6 letters, p<0.001) after 7.5 injections on average, with similar outcomes for bevacizumab (3,109 eyes, +5.5 letters; CI, +4.7 to +6.3 letters, p<0.001, average 7.9 injections) and ranibizumab (1,352 eyes, +4 letters; CI, +2.9 to +5.2 letters, p<0.001, average 7.7 injections).

The mean number of corticosteroid, and macular and panretinal laser treatment sessions were similar in each group. In the 12-month cohort, when stratified by baseline VA (in parentheses):
• in the aflibercept group, the final mean letters gained or lost were: +28 (20/201 or worse); +10.2 (20/71 to 20/200); +2.8 (20/41 to 20/70); and -2.5 (20/40 or better);
• in the bevacizumab group, the final mean letters gained or lost were: +36 (20/201 or worse); +7.8 (20/71 to 20/200); +2.9 (20/41 to 20/70); and -2 (20/40 or better) letters; and
• in the ranibizumab group, the final mean letters gained or lost were: +30.5 (20/201 or worse); +7.9 (20/71 to 20/200); +1.6 (20/41 to 20/70); and -2.7 (20/40 or better).

Researchers concluded real-world VA outcomes following anti-VEGF therapy for DME were meaningfully inferior to those noted in randomized, controlled trials. They added that eyes with better baseline VA gained fewer letters compared with those with worse baseline VA and that the initial choice of anti-VEGF agent didn’t correlate with visual outcomes.

SOURCE: Ciulla TA, Bracha P, Pollack J, et al. Real-world outcomes of anti-vascular endothelial growth factor therapy in diabetic macular edema in the United States. Ophthalmology Retina 2018; July 28. [Epub ahead of print].

Structural Neurodegeneration Correlates with Early Diabetic Retinopathy

Investigators examined differences in structural and functional neurodegenerative measurements between individuals with no and early diabetic retinopathy, as part of a cross-sectional study.

They examined 103 people with type 2 diabetes mellitus. In 7-field fundus photographs acquired with the Topcon TRC-NW6S, a single, certified grader determined the presence of DR according to the Early Treatment Diabetic Retinopathy Study scale. Retinal neurodegeneration was evaluated using Topcon 3D OCT-2000 spectral-domain optical coherence tomography and RETI-scan multifocal electroretinography (mf-ERG) system in rings one to six.

Median age of diabetes was 63.6, and mean duration was 10 years; 46 percent of participants were men. Median HbA1c was 50 mmol/mol (6.7 percent) and ETDRS levels were 10 (41.7 percent, n=43), 20 (35 percent, n=36) and 35 (23.3 percent, n=24). The duration of diabetes increased with higher levels of DR (p=0.04), but individuals with different levels of DR didn’t differ according to age, sex, blood pressure, HbA1c and mf-ERG or OCT parameters. In a multiple logistic regression model, macular ganglion cell layer thickness was associated with presence of DR (OR 1.73 per 5 μm increase, CI 1.06 to 2.85, p=0.03). Conversely, retinal nerve fiber layer thickness at the optic disc was inversely related to DR (OR 0.69 per 5 μm increase, CI 0.51 to 0.95, p=0.02). Investigators found no associations between DR and mf-ERG outcomes.

Investigators determined that structural neurogenic characteristics were associated with DR in individuals with type 2 diabetes. They wrote that, if the findings were confirmed by larger prospective studies, the results might indicate that complex neurovascular interactions were early events in the pathogenesis of DR.

Source: Frydkjaer-Olsen U, Soegaard Hansen R, Peto T, et al. Structural neurodegeneration correlates with early diabetic retinopathy. Int Ophthalmol 2018;38:4:1621-6.

Safety & Efficacy of Anti-VEGF Therapies for Neovascular AMD

Researchers reviewed the evidence on the safety and efficacy of anti-vascular endothelial growth factor therapies to treat neovascular age-related macular degeneration, via a literature search of the PubMed and Cochrane Library databases last reviewed February 2017.

Combined searches, limited to studies published in English, yielded 191 citations, 28 of which were selected because they were clinical trials deemed clinically relevant for the Ophthalmic Technology Assessment Committee Retina/Vitreous Panel to review in full. The panel methodologist then assigned a level of evidence rating to each study.

Sixteen of 28 citations provided level I evidence supporting the use of anti-VEGF agents for neovascular AMD, including intravitreal ranibizumab, aflibercept and bevacizumab. Eight studies provided level II evidence, and four provided level III evidence (only level I studies were included in the assessment). Long-term follow-up data on the efficacy of ranibizumab and bevacizumab (≥5 years) was available; however, researchers noted that this data is biased by some incomplete follow-ups.

Researchers determined that their literature review indicated that intravitreal injection of anti-VEGF therapy was safe and effective for nAMD over two years—the period for which data is available. They added that further research would be needed to evaluate the long-term safety and comparative efficacy of these agents.

SOURCE: Bakri SJ, Thorne JE, Ho AC, et al. Safety and efficacy of anti-vascular endothelial growth factor therapies for neovascular age-related macular degeneration. Ophthalmology 2018; Aug 2. [Epub ahead of print].

OCT, FA & Diagnosis of CNV in AMD

Scientists determined the sensitivity and specificity of different retinal imaging combinations to diagnose choroidal neovascularization in age-related macular degeneration.

Individuals age 50 or older referred for suspicious recent-onset CNV related to AMD were prospectively studied for six months. Data recorded included color fundus photographs, spectral-domain optical coherence tomography and fluorescein angiography images. Five retina specialists randomly interpreted SD-OCT combined with CFP and FA combined with CFP. The reference diagnosis of CNV was based on the agreement of two readers’ interpretation of SD-OCT + FA + CFP combination. A total of 148 (148 eyes) were included. The researchers’ results included:

• For CNV diagnosis, the sensitivity of SD-OCT + CFP and FA + CFP was 90.9 percent.
• Type 2 CNV was diagnosed in 98 to 100 percent of cases with SD-OCT + CFP or FA + CFP.
• Type 1 CNV was diagnosed in 82.9 percent of cases with SD-OCT + CFP and 81.6 percent with FA + CFP.

Scientists wrote that SD-OCT combined with CFP had sensitivity and specificity similar to those of FA combined with CFP when used as a first diagnostic test for CNV in AMD. They added that the results pointed to the increasingly important role of SD-OCT as a first-line test in diagnosing CNV.

SOURCE: Gualino V, Tadayoni R, Cohen SY, et al. Optical coherence tomography, fluorescein angiography, and diagnosis of choroidal neovascularization in age-related macular degeneration. Retina 2018; Jul 24. [Epub ahead of print].

Macular Pigment Distribution as Prognostic Marker for MacTel Type 2 Progression

Researchers evaluated macular pigment distribution pattern as a prognostic marker for disease progression in individuals with macular telangiectasia type 2, as part of a retrospective cohort study.

They analyzed 90 eyes of 47 individuals in this single-center study, and measured pigment optical density with dual wavelength fundus autofluorescence. Independent graders (blinded) assigned eyes into MPOD distribution classes 1 to 3 with increasing loss of macular pigment. They defined best-corrected visual acuity, reading acuity, total scotoma size in fundus-controlled perimetry (microperimetry) and break of the ellipsoid zone in optical coherence tomography (en face measurement) as functional and morphologic outcome parameters, and evaluated the eyes at baseline and after 60 months.

After a mean review period of 59.6 months (±SD 5.2 months), researchers found no change between MPOD classes compared with baseline. Morphologic and functional deficits were limited to the area of MPOD loss. At follow-up, they recorded a significant decrease of mean VA and reading acuity, as well as a significant increase of mean scotoma size and EZ break in eyes assigned to MPOD classes 2 and 3, while parameters remained stable in class 1 eyes.

Researchers wrote that the results indicated that MPOD and its distribution might serve as a prognostic marker for disease progression and functional impairment in individuals with MacTel.

SOURCE: Müller S, Issa PC, Heeren TFC, et al. Macular pigment distribution as prognostic marker for disease progression in macular telangiectasia type 2. Am J Ophthalmol 2018; Jul 24. [Epub ahead of print].

Comparison of Three Intravitreal Treatment Modalities of Macular Edema Due to BRVO

Scientists compared the efficacy of intravitreal injections of ranibizumab and aflibercept, and dexamethasone implants for the management of macular edema related to branch retinal vein occlusion, as part of a retrospective and comparative study including 62 eyes of 62 individuals with BRVO and ME.

Individuals received one of the following treatments: 0.5-mg ranibizumab (group 1, n = 22); 0.7 mg dexamethasone implant (group 2, n = 20); or 2-mg aflibercept (group 3, n = 20). The six-month treatment protocol in groups 1 and 3 consisted of three-dose loading treatments for the first three months, followed by repeat injections based on clinical necessity. Group 2 received only a single dose of 0.7 mg dexamethasone implant for six months. Visual acuity, central macular thickness, serous retinal detachment height and intraocular pressure measurements were performed at baseline and the first six months of follow-up.

At baseline, the groups didn’t differ in age, gender, duration of ME, VA, CMT, IOP or SRD height (p>0.05). Mean number of injections per eye within six months were 3.64 ±0.49 (range: 3 to 4) in group 1; one in group 2 and 3.35 ±0.49 (range: 3 to 4) in group 3. VA was significantly better in group 2 in the first three months, but it became the worst among the three groups in the sixth month. CMT didn’t differ between groups in the first three months, but it was significantly higher in group 2 at the sixth month. SRD height was significantly lower in group 2 in the first three months, but there was no difference between the groups at the end of the sixth month. IOP was significantly higher in group 2 in the third and sixth months.

Scientists wrote that, in the treatment of ME associated with BRVO, the dexamethasone implant appeared to be more advantageous in terms of VA and SRD height for the first three months. However, they added, at the end of the sixth month of treatment, anti-VEGF drugs were more efficient in maintaining the increased VA and reduced CMT. As such, scientists further wrote that dexamethasone implants might be a prudent first treatment option in BRVO cases with high SRD.

SOURCE: Kaldırım HE, Yazgan S, et al. A comparison of three different intravitreal treatment modalities of macular edema due to branch retinal vein occlusion. Int Ophthalmol. 2018;38:4:1549-58.

Segmentation Errors & Motion Artifacts in OCTA in Different Diseases

In a retrospective analysis, scientists assessed the prevalence of segmentation errors and motion artifacts in optical coherence tomography angiography in different retinal diseases.

Multimodal retinal imaging, including OCTA, was performed in one eye of 57 healthy controls (50.96 ±22.4 years) and 149 individuals (66.42 ±14.1 years) affected by different chorioretinal diseases:
• early/intermediate age-related macular degeneration (n=26);
• neovascular AMD (n=22);
• geographic atrophy due to AMD (GA; n=6);
• glaucoma (n=28);
• central serous chorioretinopathy (n=14);
• epiretinal membrane (n=26);
• retinal vein occlusion (n=11); and
• retinitis pigmentosa (n=16).

Central 3 × 3 mm2 OCTA imaging was performed with active eye-tracking (AngioVue, Optovue). Best-corrected visual acuity and signal strength index were recorded. Images were independently evaluated by two graders using the OCTA motion artifact score (MAS; score of I to IV), as well as a newly introduced segmentation accuracy score (score I to IIB).

Mean SSI was 63.67 ±9.2 showing a negative correlation with increasing age (rSp=-0.42, p<0.001, n=206). The study’s findings included the following:

• In the healthy cohort, mean MAS was 1.45 ±0.8 and segmentation was accurate (SAS I) in all eyes. In eyes with retinal pathologies, mean MAS was 2.1 ±0.9 (p<0.001). The lowest MAS was observed in GA (2.67 ±0.5) and RVO (2.45 ±1.1).
• Compared with an accurate segmentation in 100 percent of healthy subjects, 34.2 percent (n=51) of all individuals showed the highest segmentation quality (p<0.001).
• A total of 63.8 percent showed segmentation errors in more than 5 percent of all single B-scans in one (SAS IIA, n=58) or at least two (SAS IIB, n=40) segmentation boundaries. The highest percentage of inaccurate segmentation (SAS IIA or IIB) was observed in the nAMD group (90.1 percent). The inner plexiform layer was the segmentation boundary most prone to inaccurate segmentation in all pathologies compared with the inner limiting membrane and retinal pigment epithelium segmentation layer. Incorrect ILM segmentation was only seen in individuals with EM.

Scientists wrote that, prior to both qualitative and quantitative analysis, OCTA images must be carefully reviewed, as motion artifacts and segmentation errors in OCTA technology were frequent, particularly in pathologically altered maculas.

SOURCE: Lauermann JL, Woetzel AK, Treder M, et al. Prevalences of segmentation errors and motion artifacts in OCT-angiography differ among retinal diseases. Graefes Arch Clin Exp Ophthalmol 2018; July 7. [Epub ahead of print].

Fractal Dimension & OCTA Features of Central Macula After RRD Repair

Investigators wrote that individuals with macula-off rhegmatogenous retinal detachments might have suboptimal visual recovery despite successful reattachment. They evaluated the retinal microvasculature in subjects undergoing surgery for RRD using optical coherence tomography angiography.

In this case-control study, investigators compared analyses of OCTA findings of 19 eyes of 19 individuals (15 men) who underwent RRD surgery at a tertiary institute with 19 eyes of 19 age- and sex-matched healthy subjects with no known ocular disease. OCTA scans (3 × 3 mm) were obtained at three months postoperatively and analyzed. Researchers analyzed OCTA images of individuals with RRD and control subjects for capillary density index and fractal dimensions.

The mean age for study eyes was 40.21 years and 43.73 years for control eyes. Eight eyes underwent scleral buckling alone, and 11 underwent primary vitrectomy with gas tamponade (C3F8 gas) for macula-off RRD. No eyes had re-detachment during the follow-up at three months. Mean capillary density index was 33.28 ±0.99 percent in the superficial group and 34.06 ±2.22 percent in the deep retinal plexus group, compared with 36.11 ±1.29 percent in the superficial group and 37.52 ±1.24 in the deep retinal plexus group, among controls (p<0.001). The mean fractal dimension was lower in study eyes compared with controls: 1.46 vs. 1.61 in the superficial plexus group (p<0.001) and 1.58 vs. 1.64 in the deep plexus group (p<0.001).

Investigators concluded that OCTA demonstrated significant reduction in mean capillary density index and fractal dimension in individuals after surgery for RRD. As such, they suggested that reduction in vascular perfusion and branching patterns identified using novel analysis techniques on OCTA images might provide an insight into the reasons for suboptimal visual gain after RRD surgery.

SOURCE: Agarwal A, Aggarwal K, Akella Madhuri, et al. Fractal dimension and optical coherence tomography angiography features of the central macula after repair of rhegmatogenous retinal detachments. Retina 2018; Aug. 3. [Epub ahead of print].


FDA Approves Eylea Injection SBLA In Wet AMD

Regeneron recently announced that the U.S. FDA has approved a supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection in individuals with wet age-related macular degeneration. The sBLA was based on second-year data from the Phase III VIEW 1 and 2 trials in which individuals with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). These data are now included in the updated Eylea label. Read more.

Source: Regeneron, August 2018

AI Equal to Experts in Detecting Eye Diseases

Researchers from University College London, DeepMind Health and Moorfields Eye Hospital NHS Foundation Trust developed an artificial intelligence system that can recommend the correct referral decision for more than 50 eye diseases as accurately as experts. The findings, published online in Nature Medicine, describe how machine-learning technology has used thousands of eye scans to identify features of eye disease and recommend how individuals should be referred for care. The study, launched in 2016, aimed to improve the care of individuals with sight-threatening diseases. Using two types of neural networks, the AI system quickly learned to identify 10 features of eye disease from optical coherence tomography scans, and then was able to recommend a referral decision based on the most urgent conditions detected. To establish whether the system was making correct referrals, clinicians viewed the same OCT scans and made their own referral decisions. The study concluded that AI was able to make the right recommendation more than 94 percent of the time. Read more.

Source: University College London, August 2018

Researchers Reverse Congenital Blindness in Mice

Researchers, funded by the National Eye Institute, reversed congenital blindness in mice by changing Müller glia in the retina into rod photoreceptors, as reported in Nature. In the first phase of a two-stage reprogramming process, researchers spurred Müller glia in normal mice to divide by injecting their eyes with a gene to turn on a protein called beta-catenin. Weeks later, they injected the mice’s eyes with factors that encouraged the newly divided cells to develop into rod photoreceptors. The researchers found that the newly formed rod photoreceptors looked structurally no different from real photoreceptors and synaptic structures that allow the rods to communicate with other types of neurons had also formed. In mice with congenital blindness, Müller glia-derived rods developed just as effectively as they had in normal mice, and the newly formed rods communicated with other types of retinal neurons across synapses. Light responses recorded from retinal ganglion cells and measurements of brain activity confirmed that the newly formed rods were integrating in the visual pathway circuitry. Researchers are now conducting behavioral studies to determine whether the mice regained the ability to perform visual tasks such as a water maze task and will eventually see if the technique works on cultured human retinal tissue. Read more.

Source: National Eye Institute, August 2018

Stealth Expands Pipeline

Stealth BioTherapeutics, in collaboration with Evotec AG, announced Stealth’s lead candidate, elamipretide, received FDA Orphan Drug and Fast Track designation for late-stage clinical development efforts in primary mitochondrial myopathy and Leber’s hereditary optic neuropathy, among other conditions. Stealth is also developing elamipretide for dry age-related macular degeneration. Read more.

Source: Stealth BioTherapeutics, August 2018

Meiragtx AAV-CNGA3 Receives FDA Orphan Drug Designation

MeiraGTx Holdings announced that the FDA granted orphan drug designation for its AAV-CNGA3 gene therapy product candidate for the treatment of achromatopsia caused by mutations in the CNGA3 gene. AAV-CNGA3 is an investigational gene therapy treatment delivered to the cone receptors via subretinal injection and designed to restore cone function. In June 2018, the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion recommending orphan medicinal product designation for AAV-CNGA3 for the treatment of ACHM. Read more.

Source: MeiraGTx Holdings, August 2018

New Visual Tool May Help Screen for Alzheimer’s

Researchers have a promising new screening tool for Alzheimer’s disease via information about the eye. A study of 3,877 randomly selected cases found a significant link between Alzheimer’s and three degenerative eye diseases: age-related macular degeneration; diabetic retinopathy; and glaucoma. The researchers from the University of Washington School of Medicine, the Kaiser Permanente Washington Health Institute and the UW School of Nursing reported their findings in the Aug. 8 online edition of Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. Participants, ages 65 and older, didn’t have Alzheimer’s during enrollment and were part of the Adult Changes in Thought database. Over the five-year study, of 792 cases of diagnosed Alzheimer’s, individuals with AMD, DR or glaucoma were at 40 percent to 50 percent greater risk of developing Alzheimer’s compared with people without the eye conditions. Researchers said more research is necessary, but a better understanding of neurodegeneration in the eye and brain could bring more accurate, earlier diagnosis of Alzheimer’s and the development of better treatments. Read more.

Source: UW School of Medicine, August 2018

AMD Treatment May One Day Include Eye Drops

Eye drops may one day be an option for age-related macular degeneration treatment, according to a recent study in Investigative Ophthalmology & Visual Science. Researchers developed a way to topically deliver ranibizumab and bevacizumab that, in an animal model, provided the same outcomes as injected therapy. Researchers used drops with cell-penetrating peptide-mediated topical delivery to transport anti-vascular endothelial growth factor therapy into the posterior segments of rabbit and pig eyes—more similar to human eyes than rodent eyes—which were tested in a similar study last year. In the previous study, rodents that had an anti-VEGF intravitreal injections and CPP plus the anti-VEGF eye drops had significantly lower areas of neovascularization than negative control eyes. The latest study showed that the drops had a similar therapeutic effect in mammal eyes. Read more.

Source: University of Birmingham, July 2018

Wills Eye Sponsors Feasibility Study of Implantable Device for RP

Wills Eye Hospital received U.S. FDA approval to begin an early feasibility study to implant the Retina Implant Alpha AMS subretinal device in individuals who are blind due to retinitis pigmentosa. Manufactured by Retina Implant AG, Reutlingen, Germany, the device was designed to replace non-functioning and absent photoreceptor cells lost to RP deterioration. A surgically implanted Alpha AMS chip stimulates the remaining components of the visual system to restore limited functional vision in blind RP individuals, the company says. The RI Alpha AMS is an investigational device in the United States and received CE Mark approval in Europe in 2016. Read more.

Source: Wills Eye Hospital, August 2018


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