Review of Ophthalmology's Retina Online

Volume 13, Number 7
July 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.



ALERT: RETINAL COMPLICATIONS FOLLOW USE OF COMPOUNDED MEDICATION FOR “DROPLESS” CATARACT SURGERY
The American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology are aware of two separate outbreaks of acute retinal toxicity after intravitreal injection of compounded triamcinolone-moxifloxacin not produced by Imprimis...


NOVARTIS RTH258 (BROLUCIZUMAB) DEMONSTRATES VISUAL GAINS IN NAMD
Novartis reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. RTH258 3 mg, evaluated in HAWK, also met these endpoints...

And More...

 

Treat-and-extend vs. Monthly Dosing for nAMD: TREX-AMD Study

Researchers evaluated a prospective treat-and-extend management strategy compared with monthly dosing with intravitreal ranibizumab (Lucentis) in neovascular AMD, as part of a prospective, randomized, multicenter clinical trial. A total of 60 individuals with treatment-naïve nAMD were randomized 1:2 to monthly or TREX cohorts.

Individuals with Early Treatment Diabetic Retinopathy Study best-corrected visual acuity of 20/32 to 20/500 were randomized to receive intravitreal 0.5 mg ranibizumab monthly or, according to a TREX protocol, no less frequently than every 12 weeks. If recurrent exudative disease was identified after an interval extension, the maximum interval between treatments was re-challenged according to a strict prospective protocol.

The main outcome measure included a change in ETDRS BCVA from baseline. Sixty people were enrolled, and 50 completed through month 24, at which point mean ETDRS BCVA letter gains were similar: 10.5 for the monthly, and 8.7 for the TREX cohort (p=0.64). At month 24, four individuals (20 percent) in the monthly, and 12 individuals (30 percent) in the TREX cohort gained at least 15 letters (p=0.41). No monthly participant lost more than two letters, whereas five TREX individuals (13 percent) lost at least 15 letters. Anatomic improvements were similar between groups. Through month 24, the mean number of injections administered was 25.5 (range, 22 to 27) for the monthly, and 18.6 (range, 10 to 25) for the TREX group (p<0.001). Among TREX individuals completing month 24, 14 (47 percent) were at an extension interval of eight weeks or more, and the mean maximum tolerated extension was 8.5 weeks over two years. Of 26 TREX individuals (65 percent) who demonstrated recurrent exudation upon interval extension, the first maximum extension interval was consistent in most eyes (n=19 [73 percent]).

Researchers found that the TREX nAMD management protocol used with ranibizumab in the treat-and-extend protocol in individuals with wet AMD (TREX-AMD) resulted in visual and anatomic gains comparable with those obtained with monthly dosing, and most individuals randomized to TREX therapy demonstrated a relatively consistent maximum extension interval.

SOURCE: Wykoff CC, Ou WC, Brown DM, et al. Randomized trial of treat-and-extend versus monthly dosing for neovascular age-related macular degeneration: 2-year results of the TREX-AMD study. Ophthalmology Retina 2017;1:4):314-21. [Epub ahead of print].


 

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High-dose Aflibercept for Recalcitrant nAMD

Researchers evaluated the efficacy of monthly (0.1 mL/4 mg) aflibercept for refractory neovascular age-related macular degeneration, as part of a retrospective, interventional case series in which individuals with nAMD were treated with stepwise dose escalation.

Nonvitrectomized individuals resistant to monthly ranibizumab/bevacizumab were switched to 2 mg aflibercept every eight weeks. With resistance, they were escalated to q4w 2 mg aflibercept, then q4w 4 mg (high-dose high frequency, 4q4w) aflibercept. Resistance was defined as ≥2 recurrences after being dry following ≥3 injections or persistent exudation on treatment of ≥5 injections.

Thirty-three eyes of 28 individuals were treated with 4q4w aflibercept and followed for a mean of 16 months. A dry retina (no intraretinal or subretinal fluid) was achieved after initiating 4q4w aflibercept treatment at a mean of 3.8 months. Central foveal thickness, maximum foveal thickness, intraretinal fluid, subretinal fluid and retinal pigment detachment height decreased significantly at one month after initiating the 4q4w aflibercept, and the morphologic therapeutic effect was sustained until the last visit. Forty-five percent of eyes had one or more lines of vision improvement. New geographic atrophy developed in 9 percent of eyes during follow-up. No ocular or systemic adverse events occurred after initiating 4q4w aflibercept.

Researchers concluded that intravitreal high-dose, high-frequency aflibercept was an effective treatment for individuals with refractory nAMD.

Source: You QS, Gaber R, Meshi A, et al. High-dose high-frequency aflibercept for recalcitrant neovascular age-related macular degeneration. Retina 2017; Jun 9. [Epub ahead of print].





Intravitreal Ranibizumab’s Effect on Ocular Circulation of Untreated Fellow Eyes

Scientists assessed the effects of unilateral intravitreal ranibizumab on the ocular circulation of fellow eyes. They studied 15 eyes of 15 individuals with macular edema (average age: 69.6 ±11.8 years). Eleven eyes had diabetic macular edema, and four had macular edema associated with a branch retinal vein occlusion.

Each eye received 0.5 mg of IVR. Scientists determined blood circulation on the optic nerve head of treated and untreated eyes by laser speckle flowgraphy (LSFG, Softcare) before; one day; and one week after IVR. They determined mean blur rate and relative change of the MBR: dMBR (percent)=100−[MBR before/MB after] × 100. They also calculated the central macular thickness and rate of reduction in thickness (dCMT=100−[CMT before/CMT after] × 100).

The mean dMBR was significantly higher in treated eyes than untreated eyes at one day (-16.4 ±17 percent vs. 2.31 ±19.3 percent) and one week (-12 ±14.6 percent vs. 4.50 ±25.9 percent) after IVR (p=0.02, paired T tests).

Scientists found that, if ranibizumab entered the systemic circulation, the concentration was not high enough to affect the ocular circulation of the fellow eyes.

SOURCE: Sugimoto M, Nunome T, Sakamoto R, et al. Effect of intravitreal ranibizumab on the ocular circulation of the untreated fellow eye. Graefes Arch Clin Exp 2017; Jun 28. [Epub ahead of print].





Bevacizumab Injection in nAMD Increases Angiogenic Biomarkers

Researchers examined the expression of 19 angiogenic biomarkers in the aqueous humor before and after intravitreal bevacizumab injection in eyes with neovascular age-related macular degeneration, as part of a prospective, noncomparative, interventional case series.

Twenty-three eyes of 23 treatment-naïve cases with choroidal neovascularization secondary to nAMD were included. Eyes were diagnosed with CNV secondary to nAMD and treated with three monthly IVBs. Aqueous humor samples were obtained by anterior chamber paracentesis at baseline and immediately before each intravitreal bevacizumab injection.

Main outcome measures included aqueous humor levels of 19 angiogenic biomarkers:
• angiopoietin 2;
• bone morphogenetic protein 9;
• epidermal growth factor;
• endoglin;
• endothelin 1;
• fibroblast growth factor-1 and FGF-2;
• follistatin;
• granulocyte colony-stimulating factor;
• heparin-binding EGF-like growth factor;
• hepatocyte growth factor;
• interleukin 8;
• leptin;
• placental growth factor;
• vascular endothelial growth factor-A, -C and -D; and
• tissue inhibitor of metalloproteinases-1 and TIMP-2.
Best-corrected visual acuity, spectral-domain OCT parameters and intraocular pressure also were evaluated.

Baseline aqueous VEGF-A expression was elevated in all study eyes before treatment initiation. A statistically significant decrease of VEGF-A was observed at the one- and two-month follow-ups. A statistically significant increase in concentration was observed in seven biomarkers: VEGF-C; angiopoietin 2; endothelia 1; follistatin; HB-EGF; HGF; and interleukin 8.The BCVA showed statistically significant improvement at two months, with SD-OCT parameters revealing the improvement at all follow-ups. Mean IOP values were not statistically significantly different during the study.

In light of these results, researchers suggested that these seven upregulated angiogenic biomarkers might represent new therapeutic targets for exudative AMD.

Source: Cabral T, Lima LH, Mello LGM, et al. Bevacizumab injection in patients with neovascular age-related macular degeneration increases angiogenic biomarkers. Ophthalmology Retina 2017; June 20. [Epub ahead of print].





AMD in Chronic Myeloproliferative Neoplasms

Researchers compared the risk of age-related macular degeneration in individuals with myeloproliferative neoplasms and matched controls, as part of a nationwide, population-based cohort study using Danish registers.

Individuals in Denmark who received a diagnosis of essential thrombocythemia, polycythemia vera, myelofibrosis or unclassifiable MPNs between Jan. 1, 1994, and Dec. 31, 2013, were included. Researchers included 10 age- and sex-matched controls for each diagnosed person. All individuals without prior AMD were followed from the date of diagnosis (or corresponding entry date for controls) until the first AMD diagnosis, death, emigration or Dec. 31, 2013, whichever occurred first. Data analysis was performed from April 1, 2015, to Oct. 31, 2016.

The main outcomes and measure included incidence of AMD recorded in specialized hospital-based care centers. Researchers calculated:
• the rates and absolute risk of AMD;
• smoking and risk-time adjusted hazard ratios between participants and controls using Cox proportional hazards regression models; and
• HRs of neovascular AMD after 2006 since anti-vascular endothelial growth factor treatment was introduced nationwide at hospitals thereafter.

A total of 7,958 individuals with MPNs (4,279 women [53.8 percent] and 3,679 men [46.2 percent]; mean [SD] age at diagnosis: 66.4 [14.3] years) were included. The rate of AMD per 1,000 person-years at risk was 5.2 (CI, 4.6 to 5.9) for individuals with MPNs (2,628 with essential thrombocythemia, 3,063 with polycythemia vera, 547 with myelofibrosis and 1,720 with unclassifiable MPNs); and 4.3 (CI, 4.1 to 4.4) for the 77,445 controls. The 10-year risk of AMD was 2.4 percent (CI, 2.1 to 2.8 percent) for individuals with MPNs and 2.3 percent (CI, 2.2 to 2.4 percent) for controls. The risk of AMD increased overall for individuals with MPNs (adjusted HR, 1.3; CI, 1.1 to 1.5), with adjusted HRs for subtypes of 1.2 (CI, 1.0 to 1.6) for essential thrombocythemia; 1.4 (CI, 1.2 to 1.7) for polycythemia vera; 1.7 (CI, 0.8 to 4) for myelofibrosis; and 1.5 (CI, 1.1 to 2.1) for unclassifiable MPNs. In addition, individuals with MPNs had a higher risk of nAMD (adjusted HR, 1.4; CI, 1.2 to 1.6).

Researchers wrote that the results suggested that individuals with MPNs were at increased risk of AMD, supporting the possibility that systemic inflammation was involved in the pathogenesis of AMD.

SOURCE: Bak M, Sørensen TL, Flachs EM, et al. Age-related macular degeneration in patients with chronic myeloproliferative neoplasms. JAMA Ophthalmol 2017; Jun 22. [Epub ahead of print].





Nonperfusion Area on Ultra-wide Field FA in Eyes with DME: DAVE Study

Scientists examined the distribution of nonperfusion area in eyes with diabetic macular edema and its relationship to the severity of DME, as part of a prospective, observational case series.

Forty eyes of 29 individuals with treatment-naïve DME who participated in the DAVE study were included. Ultra-wide field fluorescein angiography images were sent to the Doheny Image Reading Center to be montaged and adjusted by stereographic projection for peripheral distortion. Two experienced, independent/masked certified graders manually segmented the NPA and total visible retinal area, and computed the NPA and TRA in mm2. They calculated the ischemic index, and correlated the distribution of NPA and ISI within different retinal zones with the severity of DME.

In 40 eyes of treatment-naïve DME subjects (mean age: 55.8 years), visual acuity (mean 59.6 EDTRS letters) was correlated with central macular thickness (mean 536.9 μm, r=-0.418, p=0.008) and macular volume (mean 11.9 mm3, r=-0.449; p=0.004). The NPA and ISI among the different retinal zones were significantly different (NPA: p<0.001; ISI: p=0.005). The NPA and ISI in the mid-periphery were negatively associated with CMT (NPA: p=0.04; ISI: p=0.02). However, the global NPA and ISI for the entire retina weren’t associated with CMT or MV (p>0.05).

Scientists concluded that, in eyes with DME, the ISI increased with greater distance from the fovea. They added that DME severity didn’t appear to correlate with global NPA and ISI.

SOURCE: Fan W, Wang K, Ghasemi Falavarjani K, et al. Distribution of nonperfusion area on ultra-wide field fluorescein angiography in eyes with diabetic macular edema: DAVE study. Am J Ophthalmol 2017; Jun 1. [Epub ahead of print].




Differential Microvascular Assessment of RVO With OCTA & FA

Researchers compared retinal vein occlusion imaging by optical coherence tomography angiography and fluorescein angiography, and evaluated the modalities’ roles in clinical management.

Individuals with RVO who underwent imaging with FA and OCTA from June 1, 2015, to December 31, 2015, were enrolled. An independent retinal specialist whose identity was kept hidden assessed the FA and OCTA reports using a pixel-counting technique for FAZ size measurement. A significant level of p<0.05 was employed for correlation and agreement analysis.

On OCTA, the mean foveal avascular zone size was 0.382 ±0.152 mm2 and 0.606 ±0.136 mm2 for superficial and deep retinal layers, with significant correlation (p=0.004). On FA, the mean FAZ size was 0.352 ±0.158 mm2, which better correlated with OCTA at the superficial (p=0.062) than the deep retinal layer (p=0.122). Between FA and OCTA, good agreement was found for microaneurysms (100 percent; p=0.001) and venous congestion (83.33 percent; p=0.028), but not capillary nonperfusion (p=0.217) and venous tortuosity (p=0.546). OCTA also revealed more capillary nonperfusion than FA (91.67 percent vs. 58.33 percent). The presenting best-corrected visual acuity was significantly correlated with capillary nonperfusion on OCTA (p=0.001).

Researchers wrote that OCTA and FA were complementary tools in RVO assessment. While they found that OCTA was more precise in assessing the FAZ and capillary nonperfusion, they determined that FA offered better vascular imaging of the peripheral retina.

SOURCE: Chung CY, Tang HHY, Li SH, et al. Differential microvascular assessment of retinal vein occlusion with coherence tomography angiography and fluorescein angiography: A blinded comparative study. Int Ophthalmol 2017; May 26. [Epub ahead of print].




Ranibizumab vs. Dexamethasone Implants for CRVO: The RANIDEX Study

Scientists compared intravitreal ranibizumab and dexamethasone implants in individuals with macular edema secondary to central retinal vein occlusion. Participants included 42 treatment-naive individuals with ME due to CRVO who received either intravitreal 0.5 mg ranibizumab (n=25) or intravitreal 0.7 mg dexamethasone implants (n=17).

The main outcomes included the mean change in best-corrected visual acuity and central subfield thickness at month 12 compared with baseline in the two groups.

At month 12, no statistically significant difference in BCVA and CST change was detected between the two groups. However, scientists reported a recurrence in ME at month five in the dexamethasone group.

Scientists wrote that both ranibizumab and the dexamethasone implant appeared to be safe and effective at the 12-month follow-up in individuals with ME secondary to CRVO. Due to a recurrence in ME at month five in the dexamethasone group, scientists suggested that intravitreal injection of dexamethasone implant should be potentially administered sooner than six months.

SOURCE: Chatziralli I, Theodossiadis G, Kabanarou SA, et al. Ranibizumab versus dexamethasone implant for central retinal vein occlusion: The RANIDEX study. Graefes Arch Clin Exp Ophthalmol 2017; Jun 15. [Epub ahead of print].




Vision-related Quality of Life for Noninfectious Uveitis Treated With Fluocinolone Acetonide Implants or Systemic Corticosteroid Therapy

Investigators assessed longitudinal vision-related quality of life in individuals with noninfectious uveitis, as part of a cohort study using randomized controlled trial data. Participants included individuals with active or recently active intermediate uveitis, posterior uveitis or panuveitis enrolled in the Multicenter Steroid Treatment Trial and Follow-up Study.

Investigators analyzed data semiannually from the 25-item National Eye Institute Visual Functioning Questionnaire for the first three years after randomization. Analyses were stratified by assigned treatment (129 implants vs. 126 systemic therapies) because of substantial differences in the trajectories of vision-related QoL. Investigators looked at the impact of baseline measurements of visual function (visual acuity and visual field), demographics and disease characteristics using generalized estimating equations. The primary outcome was the NEI-VFQ-25 composite score over three years after randomization.

Individuals in both treatment groups showed similar improvement in NEI-VFQ-25 scores after three years of follow-up (implant: 11.9 points; CI, 8.6 to 15.2; p<0.001; systemic: 9 points; CI, 5.6 to 12.3; p<0.001; p=0.21 for interaction). Individuals in the implant group showed a substantial improvement during the first six months, followed by stable scores, whereas individuals in the systemic group showed a steady improvement over the course of follow-up. Worse initial VA and VFs were associated with lower initial NEI-VFQ-25 scores for both treatment groups. In the systemic group, these differences were maintained throughout follow-up. In the implant group, individuals with initial VA worse than 20/40 showed additional improvement in NEI-VFQ-25 scores to come within -7 points (CI, 15 to 0.9) of those with VA 20/40 or better initially—a clinically meaningful but not statistically significant difference (p=0.081). Results based on sensitivity analyses showed similar patterns.

Both treatment groups demonstrated significant improvements in NEI-VFQ-25 scores, although improvements were immediate for the implant group vs. gradual for the systemic group. Investigators determined that poorer visual function was associated significantly with initial differences in NEI-VFQ-25 scores; however, they found that only individuals with poor VA in the implant group overcame their deficits by the end of three years.

SOURCE: Sugar EA, Venugopal V, Thorne JE, et al. Longitudinal vision-related quality of life for patients with noninfectious uveitis treated with fluocinolone acetonide implant or systemic corticosteroid therapy. Ophthalmology 2017; Jun 14. [Epub ahead of print].




Systematic Increase of Corticosteroid-related AEs in Noninfectious Intermediate, Posterior or Panuveitis

Investigators wrote that chronic use of corticosteroids to treat uveitis has been linked with drug-associated toxicity and adverse events. They examined the association between corticosteroid dosage and incidence rates of corticosteroid-related AEs, as part of a post hoc analysis of the VISUAL-1 and VISUAL-2 placebo-controlled clinical trials funded by AbbVie, maker of the steroid-sparing uveitis treatment adalimumab (Humira).

The trials consisted of adults with active (VISUAL-1) and inactive (VISUAL-2) noninfectious intermediate, posterior and panuveitis. Individuals were randomized to receive adalimumab or placebo, and they underwent a protocol-defined mandatory taper to discontinue their oral corticosteroids.

AE data and an assessment of the corticosteroid relationship were collected at visits. Investigators used a longitudinal Poisson regression model to control for time-dependent corticosteroid dose, age, sex, prior oral corticosteroid dose, prior topical corticosteroid use and concomitant immunosuppressive drug use. Only individuals randomized to the placebo were considered. The main primary outcome measure was AE frequency.

The incidence rates of corticosteroid-related AEs among placebo participants during the prednisone treatment period in VISUAL-1 was statistically higher than after discontinuation (454.2 per 100 patient-years vs. 36.1 per 100 PYs: incident rate ratio=12.6, p<0.001). Incidence rate ratios among VISUAL-2 individuals were similarly high (317.5 per 100 PYs vs. 41.1 per 100 PYs: incident rate ratio=7.7, p<0.001). Based on the Poisson multivariate longitudinal Generalized Estimating Equation model, each 10-mg increase in prednisone dose was associated with a 1.5- and 2.6-fold increase (p<0.001 and p<0.001) in the rates of corticosteroid-related AEs in VISUAL-1 and VISUAL-2, respectively. This indicated that an individual with active uveitis taking 60 mg/day of prednisone would likely experience, on average, an additional 10.1 (CI, 6.3 to 14.5; p<0.001) corticosteroid-related AEs per year compared with an individual taking 10 mg/day, whereas a person with inactive uveitis taking 35 mg/day of prednisone would experience, on average, an additional 23.5 (CI, 7.6 to 52.7; p=0.05) corticosteroid-related AEs per year compared with a person taking 10 mg/day.

Investigators found that evidence from VISUAL-1 and VISUAL-2 trials suggested that the incidence rates of corticosteroid-related AEs increased systematically with corticosteroid dose.

SOURCE: Suhler EB, Thorne JE, Mittal M, et al. Corticosteroid-related adverse events systematically increase with corticosteroid dose in noninfectious intermediate, posterior, or panuveitis: Post hoc analyses from the Visual-1 and Visual-2 trials. Ophthalmology 2017; Jul 6. [Epub ahead of print].




 



ALERT: RETINAL COMPLICATIONS FOLLOW USE OF COMPOUNDED MEDICATION FOR “DROPLESS” CATARACT SURGERY

The American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology are aware of two separate outbreaks of acute retinal toxicity after intravitreal injection of compounded triamcinolone-moxifloxacin not produced by Imprimis. The groups suggest that ophthalmologists exercise caution and due diligence when obtaining this medication from a new compounding source. These outbreaks occurred at two different Dallas surgery centers that obtained this formulation from the same Dallas compounding pharmacy, Guardian Pharmacy Services. Read more.



NOVARTIS RTH258 (BROLUCIZUMAB) DEMONSTRATES VISUAL GAINS IN NAMD

Novartis reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. RTH258 3 mg, evaluated in HAWK, also met these endpoints. The studies enrolled more than 1,800 individuals with neovascular age-related macular degeneration across 400 centers worldwide. The primary and key secondary efficacy endpoints were non-inferiority of RTH258 to aflibercept in mean change in best-corrected visual acuity from baseline to week 48, and average mean change over the period of weeks 36 to 48, respectively. Both endpoints were met with highly significant p values. RTH258 was generally well-tolerated, with overall ocular and systemic adverse event rates comparable to aflibercept. RTH258 demonstrated long-lasting efficacy vs. aflibercept dosed every eight weeks. Read more.

Source: Novartis, June 2017





Neurotech Reveals Positive Phase II Results in NT-501 for Macular Telangiectasia

Neurotech Pharmaceuticals, in collaboration with the Lowy Medical Research Institute, announced 24-month results demonstrating that NT-501 delivering ciliary neurotrophic factor had a beneficial effect in individuals with macular telangiectasia type 2. The multicenter, randomized clinical trial demonstrated a statistically significant reduction in the progressive loss of photoreceptors in treated vs. untreated eyes. NT-501 utilizes the company's proprietary Encapsulated Cell Therapy platform, which can be customized to deliver specific therapeutic molecules to the back of the eye for retinal disease. The Phase II study enrolled 67 individuals (99 eyes) at eight sites in the United States, and three people in Australia. Read more.

Source: Neurotech Pharmaceuticals, June 2017





pSivida's Durasert for Posterior Segment Uveitis Achieves Primary Efficacy Endpoint in Phase III Study

pSivida announced that the company's second Phase III trial of Durasert three-year treatment for posterior segment uveitis achieved the trial's primary endpoint. The study involving 153 participants had a primary endpoint of preventing recurrence of posterior uveitis at six months, with individuals followed for 36 months. The three-year inserts demonstrated a significant reduction in the recurrence of posterior segment uveitis through six months: 21.8 percent of Durasert-treated individuals had a recurrence vs. 53.8 percent of people in the sham group (p<0.001). Read more.

Source: pSivida, June 2017



Aerpio Initiates Patient Dosing in TIME Phase IIb Study of AKB-9778 in Diabetic Retinopathy

Aerpio Pharmaceuticals began patient dosing in the company’s TIME Phase IIb clinical trial to assess the efficacy and safety of lead candidate AKB-9778 for individuals with moderate to severe non-proliferative diabetic retinopathy. The double-masked, placebo-controlled, multicenter trial will enroll 150 individuals randomized 1:1:1 to receive either AKB-9778 15 mg subcutaneously once daily, AKB-9778 15 mg twice daily or placebo for a 12-month period. The primary endpoint is the percentage of individuals who improve by at least two steps in diabetic retinopathy Severity Score in the study eye. Secondary objectives include assessment of safety and tolerability of both dosing regimens. Read more.

Source: Aerpio Pharmaceuticals, June 2017




SECOND SIGHT EXPANDS MEDICARE COVERAGE FOR ARGUS II, ENTERS SOUTH KOREAN MARKET

Second Sight Medical Products announced the Argus II Retinal Prosthesis System is now covered by Medicare in seven of the 12 Medicare Administrative Contractor jurisdictions nationwide, representing a total of 28 states, two territories and the District of Columbia. Read more.
The company also entered the South Korean market and implanted the Argus II Retinal Prosthesis System in two individuals in Seoul, with a second patient in Taiwan receiving the company’s Argus II. Read more.

Source: Second Sight, July 2017




PROQR CANDIDATE QRX-411 RECEIVES ORPHAN DRUG DESIGNATION FROM FDA & EMA

ProQR Therapeutics’ investigational drug QRX-411 received orphan drug designation from the U.S. Food and Drug Administration and European Medicines Agency for the treatment of retinitis pigmentosa, including Usher syndrome, the subtype targeted by QRX-411. Read more.

Source: ProQR Therapeutics, July 2017




FDA Rejects Ocular Therapeutix Resubmission of Dextenza NDA

In a Complete Response Letter to Ocular Therapeutix regarding its resubmission of a New Drug Application for Dextenza (dexamethasone insert) 0.4mg for the treatment of ocular pain following ophthalmic surgery, the U.S. Food and Drug Administration stated it could not approve the NDA in its present form. The CRL referred to deficiencies in manufacturing processes and analytical testing related to the manufacture of drug products for commercial production identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility completed in May 2017. Read more.

Source: Ocular Therapeutix, July 2017




Novaliq Appoints Dr. Burian as CMO

Novaliq named Gabriela Burian, MD, MPH, Novaliq’s chief medical officer. Previously, Dr. Burian served as global program medical director at Novartis Pharma and early program leader at F. Hoffmann-La Roche. She founded and directs GB Biomed Advisors, and serves as CMO for Iconic Therapeutics. Read more.

SOURCE: Novaliq, June 2017




AGTC REPORTS POSITIVE TOPLINE DATA FOR X-LINKED RETINOSCHISIS STUDY

Applied Genetic Technologies announced positive topline safety data for the dose-escalation phase of the company’s Phase I/II X-linked retinoschisis clinical trial, a program partnering with Biogen. The first 12 subjects enrolled in low-, middle- and high-dose groups were followed for more than a year. Mild to moderate ocular inflammation was observed in the treated eyes of most individuals and resolved without further intervention, or was controlled with topical or oral corticosteroids, AGTC says. No treatment-related serious adverse events were reported, and the treatment was generally well-tolerated. Read more.

Source: AGTC, June 2017




REGENXBIO INITIATES PHASE I TRIAL OF RGX-314 GENE THERAPY FOR WET AMD

Regenxbio announced that the first patient was dosed in a Phase I clinical trial evaluating RGX-314 for individuals with wet age-related macular degeneration. This multicenter, open-label, multiple-cohort, dose-escalation clinical trial will assess the safety and tolerability of RGX-314 as a one-time therapy for individuals with previously treated wet AMD. The therapeutic option is designed to be a one-time treatment for wet AMD administered subretinally to yield local production of an anti-VEGF antibody fragment, potentially eliminating the need for additional anti-VEGF administrations. Read more.

Source: Regenxbio, May 2017




VITAL ART AND SCIENCE ANNOUNCES LICENSING AGREEMENT WITH GENENTECH

Vital Art and Science signed a license agreement with Genentech for the use of its mVT app service in Genentech’s ophthalmology clinical studies. Genentech intends to use the service to enhance patient experience, improve the effectiveness of patient interactions with health-care providers, and apply the data collected through the service to improve patient care and clinical trial design. The app is currently being used in Genentech’s Phase II LADDER study investigating the sustained delivery of Lucentis (ranibizumab injection) via Genentech’s Port Delivery System in individuals with wet age-related macular degeneration. Read more.

Source: Vital Art and Science, June 2017



PIXIUM ADVANCES FDA DISCUSSIONS FOR PRIMA FEASIBILITY STUDY

Pixium Vision is continuing its dialogue with the U.S. Food and Drug Administration to prepare the first-in-human study with PRIMA, its miniaturized wireless subretinal photovoltaic implant system. Pre-clinical support for PRIMA was strengthened with in vivo animal data presented during the Association for Research in Vision and Ophthalmology annual meeting in May. Pixium Vision will be submitting a request to the U.S. Food and Drug Administration for an Early Feasibility Study program for treating dry AMD. Read more.

Source: Pixium Vision, June 2017




HADASIT AND BIOTIME COMPLETE SHARE SWAP TRANSACTION

Hadasit Bio-Holdings completed a share swap transaction with BioTime in joint portfolio company Cell Cure Neurosciences, a biotechnological company focusing on developing cell therapy for degenerative retinal and macular diseases. Its technology is based on human embryonic stem cells, which can be produced on a mass scale for any cell of the human body. BioTime is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from pluripotent cell assets. Read more.

Source: Hadasit Bio-Holdings and BioTime, June 2017




SHIRE NAMES SNISARENKO TO SUCCEED DEMPSEY AS HEAD OF U.S. OPHTHALMICS

Shire announced that John Snisarenko was named group vice president and head of ophthalmics in the United States. He succeeds Robert Dempsey, who is now vice president and head of global ophthalmics at Shire. Snisarenko brings 30 years of experience in the pharmaceutical, biotech and medical device industries. Most recently, Snisarenko was vice president of sales and marketing for rheumatology at Genentech, where he worked on the drugs Actemra and Rituxan. Prior to that, he led sales and marketing for Genentech ophthalmology in the United States. There, he was part of the team that introduced the “Commitment to Retina” initiative, and was involved with Lucentis. Earlier in his career at Novartis Pharma Canada, Snisarenko led the integration of the ophthalmology business from CIBA Vision to Novartis Pharma. He also led the Canadian launch of the unit’s first bio-pharmaceutical medicine, Visudyne.

Source: Shire, June 2017


 

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