Volume 10, Number 3
March 2014

 

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.



QLT Reports Positive Preliminary Results from Phase Ib Retreatment Trial of QLT09001
QLT Inc. announced positive preliminary results from its international, multicenter, open-label Phase Ib clinical trial of repeated treatments of oral QLT091001...

Enrollment Begins in Wet AMD Study
In 2013, Moorfields and SalutarisMD announced their collaboration to advance the research and development of a novel medical device...

And More...

Risk Factors for Scar Formation in the CATT

Researchers conducted a prospective cohort study within a randomized clinical trial to describe risk factors for scar in eyes treated with ranibizumab or bevacizumab for neovascular age-related macular degeneration (AMD).

They included patients with no scar on color fundus photography (CFP) or fluorescein angiography (FA) at enrollment in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT).

The researchers assigned eyes to ranibizumab or bevacizumab treatment and to one of three dosing regimens for two years. Masked readers assessed CFP and FA. Baseline demographic characteristics, visual acuity, morphologic features on photography and optical coherence tomography (OCT), as well as genotypes associated with AMD risk were evaluated as risk factors using adjusted hazard ratios (aHRs) and associated 95% confidence intervals (CIs). Scars were classified as fibrotic with well-demarcated elevated mounds of yellowish white tissue or nonfibrotic with discrete flat areas of hyperpigmentation with varying amounts of central depigmentation. Scar formation was the main outcome measure.

According to the researchers, scar developed in 480 of 1,059 eyes (45.3%) by two years. Baseline characteristics associated with greater risk of scarring were predominantly classic choroidal neovascularization (CNV) (aHR, 3.1; CI, 2.4 to 3.9) vs. occult CNV, blocked fluorescence (aHR, 1.4; CI, 1.1 to 1.8), foveal retinal thickness >212 µm (aHR, 2.4; CI, 1.7 to 3.6) vs. <120 µm, foveal subretinal tissue complex thickness >275 µm (aHR, 2.4; CI, 1.7 to 3.6) vs. ≤75 µm, foveal subretinal fluid (aHR, 1.5; CI, 1.1 to 2.0) vs. no subretinal fluid, and subretinal hyper-reflective material (SHRM) (aHR, 1.7; CI, 1.3 to 2.3) vs. no SHRM. Eyes with elevation of the retinal pigment epithelium had lower risk (aHR, 0.6; CI, 0.5 to 0.8) vs. no elevation. Drug, dosing regimen and genotype had no statistically significant association with scarring. Fibrotic scars developed in 24.7% of eyes, and nonfibrotic scars developed in 20.6% of eyes. Baseline risk factors for the scar types were similar except that eyes with larger lesion size or visual acuity <20/40 were more likely to develop fibrotic scars.

In conclusion, approximately half of eyes enrolled in CATT developed scar by two years. Eyes with classic neovascularization, a thicker retina and more fluid or material under the foveal center of the retina are more likely to develop scar.

Source: Daniel E, Toth CA, Grunwald JE, et al; Comparison of Age-related Macular Degeneration Treatments Trials Research Group. Ophthalmology. 2014;121(3):656–666.

Genetic and Clinical Factors Associated with Reticular Pseudodrusen in Exudative AMD

Reticular pseudodrusen (RPD) is considered to be a distinct entity from soft drusen and a risk factor for age-related macular degeneration (AMD). The authors of this study investigated the genetic and clinical factors associated with RPD in patients with exudative AMD, including polypoidal choroidal vasculopathy (PCV), typical neovascular AMD and retinal angiomatous proliferation (RAP).

They studied the presence or absence of RPD among 408 patients with exudative AMD in at least one eye, and they investigated the clinical characteristics of those with RPD as well as genetic polymorphisms of ARMS2 A69S (rs10490924) and CFH I62V (rs800292). The authors also evaluated subfoveal choroidal thickness in a limited number of subjects using the EDI mode of spectral-domain optical coherence tomography.

The prevalence of RPD was significantly higher in RAP eyes than in typical neovascular AMD or in PCV eyes (38.2% of 26 eyes, 13.6% of 132 eyes and 0% of 250 eyes respectively, p<0.0001), the authors found. They also observed that RPD was significantly more prevalent in the elderly (p<0.0001) and female (p<0.0001) subjects. The subfoveal choroidal thickness was thinner in eyes with RPD than in those without (129.7 ± 61.7 µm vs. 42.6 ± 84.9 µm, p<0.0001). The frequency of risk variants of ARMS2 A69S was significantly higher in eyes with RPD than in those without RPD (85.7% vs. 63.8%, p=0.0009), although the frequency of CFH I62V was not significantly different between those with and without RPD. Logistic regression analysis revealed that age (odds ratio [OR]: 1.10; 95% confidence interval [CI]: 1.04 to 1.18; p=0.002), female gender (OR: 4.26; 95% CI: 1.72 to 10.4; p=0.002), T-allele at ARMS2 A69S (OR: 3.23; 95% CI: 1.36 to 7.68; p=0.008) and RAP (OR: 4.25; 95% CI: 1.49 to 12.1; p=0.007) were risk factors for RPD.

Among eyes with exudative AMD, RPD is more common in eyes with RAP having a thin choroid at the fovea, especially in old, female patients with the risk variant of ARMS2 A69S, the study authors discovered.

Source: Yoneyama S, Sakurada Y, Mabuchi F, et al. Genetic and clinical factors associated with reticular pseudodrusen in exudative age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2014; March [Epub ahead of print]. DOI: 10.1007/s00417-014-2601-y.


Frequency of Retinal Vascular Abnormalities in Neovascular AMD

Investigators undertook a post hoc subanalysis of images acquired during a Phase III randomized controlled trial to determine the prevalence of retinal vascular abnormalities (RVA) in neovascular age-related macular degeneration (AMD).

They selected images from participants with untreated, neovascular AMD in at least one eye and acquired protocol-mandated fundus photographs and fluorescein angiograms at baseline and at year two from 107 sham-treated study eyes with neovascular AMD and 107 untreated fellow eyes. Images were reanalyzed by an independent reading center for the presence of RVA, defined as at least one of the following: microaneurysms; vessel staining or leakage; dilated or tortuous vessels; intraretinal hemorrhage; vessel sheathing or narrowing; capillary nonperfusion; or capillary infarcts.

The investigators noted that the baseline prevalence of RVA in the sham-treated study eyes was 14.4% (15 of 104 gradable images) vs. 8.3% (five of 60) in the fellow eyes with dry AMD. The baseline prevalence of individual RVAs in study eyes was: microaneurysms (6.7%); vessel staining or leakage (6.7%); dilated or tortuous vessels (4.8%); intraretinal hemorrhage (4.8%); vessel sheathing or narrowing (2.9%); capillary nonperfusion (0%); and capillary infarcts (0%). Results were similar at 24 months.

Compared with several studies that relied solely on fundus photographs, this study included fluorescein angiography and found a higher prevalence of RVAs occurring in eyes with neovascular AMD.

Source: Jackson TL, Danis RP, Goldbaum M, et al. Retinal vascular abnormalities in neovascular age-related macular degeneration. Retina. 2014;34(3):568–575.


Systemic Complement Inhibition with Eculizumab for GA in AMD

To evaluate the effect of eculizumab, a systemic inhibitor of complement component (C5), on the growth of geographic atrophy (GA) in patients with age-related macular degeneration (AMD), this prospective, double-masked, randomized clinical trial included patients with GA measuring from 1.25 to 18 mm² based on spectral-domain optical coherence tomography imaging.

Patients were randomized 2:1 to receive intravenous eculizumab or placebo over six months. In the eculizumab treatment arm, the first 10 patients received a low-dose regimen of 600 mg weekly for four weeks followed by 900 mg every two weeks until week 24, and the next 10 patients received a high-dose regimen of 900 mg weekly for four weeks, followed by 1,200 mg every two weeks until week 24. The placebo group was infused with saline. Patients were observed off treatment for an additional 26 weeks. Both normal-luminance and low-luminance visual acuities were measured throughout the study, and the low-luminance deficits were calculated as the difference between the letter scores. Change in area of GA at 26 weeks was the main outcome measure.

Thirty eyes of 30 patients were enrolled; 18 fellow eyes also met inclusion criteria and were analyzed as a secondary endpoint. For the 30 study eyes, mean square root of GA area measurements ± standard deviation at baseline were 2.55 ± 0.94 and 2.02 ± 0.74 mm in the eculizumab and placebo groups, respectively (p=0.13). At 26 weeks, GA enlarged by a mean of 0.19 ± 0.12 and 0.18 ± 0.15 mm in the eculizumab and placebo groups, respectively (p=0.96). At 52 weeks of follow-up, GA enlarged by a mean of 0.37 ± 0.22 mm in the eculizumab-treated eyes and by a mean of 0.37 ± 0.21 mm in the placebo group (p=0.93, two sample t test). None of the eyes converted to wet AMD and no drug-related adverse events were identified.

Systemic complement inhibition with eculizumab was well-tolerated through six months, but did not decrease the growth rate of GA significantly. However, there was a statistically significant correlation between the low-luminance deficit at baseline and the progression of GA over six months.

Source: Yehoshua Z, de Amorim Garcia Filho CA, Nunes RP, et al. Systemic complement inhibition with eculizumab for geographic atrophy in age-related macular degeneration: the COMPLETE Study. Ophthalmology. 2014;121(3):693–701.


Use of Ranibizumab for Patients with CNV Secondary to Pathologic Myopia

This Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study compared the efficacy and safety of ranibizumab 0.5 mg, guided by visual acuity (VA) stabilization or disease activity criteria, versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (CNV).

Participants consisted of patients (n=277) with visual impairment due to myopic CNV. Patients were randomized to receive ranibizumab on day one, month one and thereafter as needed guided by VA stabilization criteria (group one, n=106); ranibizumab on day one and thereafter as needed guided by disease activity criteria (group two, n=116); or vPDT on day one and disease activity treated with ranibizumab or vPDT at investigators' discretion from month three (group three, n=55). Mean average best-corrected visual acuity (BCVA) change from baseline to month one through months three (primary) and six, mean BCVA change and safety over 12 months were the main outcome measures.

Ranibizumab treatment in groups one and two was superior to vPDT based on mean average BCVA change from baseline to month one through month three (group one: +10.5, group two: +10.6 vs. group three: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both p<0.0001). Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month one through month six (group two: +11.7 vs. group one: +11.9 ETDRS letters; p<0.00001). Mean BCVA change from baseline to month 12 was +13.8 (group one), +14.4 (group two), and +9.3 ETDRS letters (group three). At month 12, 63.8% to 65.7% of patients showed resolution of myopic CNV leakage. Patients received a median of 4.0 (group one) and 2.0 (groups two and three) ranibizumab injections over 12 months. No deaths or cases of endophthalmitis and myocardial infarction occurred.

Ranibizumab treatment, irrespective of retreatment criteria, provided superior BCVA gains versus vPDT up to month three. Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month six. Over 12 months, individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well-tolerated in patients with myopic CNV.

Source: Wolf S, Balciuniene VJ, Laganovska G, et al; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014;121(3):682–692.


Combination Therapy for BRVO: Dexamethasone Intravitreal Implant and Macular Grid Laser

Italian researchers performed the following prospective, interventional, randomized, multicenter study to test a combination of dexamethasone intravitreal implant with macular grid laser for macular edema in patients with branch retinal vein occlusion (BRVO).

Patients with macular edema secondary to BRVO underwent an Ozurdex intravitreal implant at baseline. After one month, the researchers randomly assigned patients to two study groups. Patients in group one were followed up monthly and retreated with Ozurdex implant whenever there was a recurrence of macular edema or a decrease in best-corrected visual acuity (BCVA). In group two patients, macular grid laser was performed between weeks six and eight. After that, patients were followed up and retreated as for group one.

According to the study researchers, in group one at four months, mean BCVA was 0.49 ± 0.35 logMAR and central retinal thickness (CRT) was 391 ± 172 µm; both improved significantly at six months, to 0.32 ± 0.29 logMAR and 322 ± 160 µm, respectively. In group two, CRT was reduced significantly to 291 ± 76 µm at four months, and BCVA improved to 0.25 ± 0.20 logMAR. At the final visit, BCVA was 0.18 ± 0.14 logMAR and mean CRT was 271 ± 44 µm. The number of Ozurdex implants at four months was 12 of 25 (48%) in group one patients vs. three of 25 (12%) in group two patients (p=0.012). At six months, three of 25 patients (12%) in group one vs. zero of 25 (0%) in group two (p=0.23) were retreated.

The combination of Ozurdex implant and macular grid laser is synergistic in increasing BCVA and lengthening the time between injections, the researchers concluded.

Source: Pichi F, Specchia C, Vitale L, et al. Combination therapy with dexamethasone intravitreal implant and macular grid laser in patients with branch retinal vein occlusion. Am J Ophthalmol. 2014;157(3):607–615.


Link Between FAF with Foveal Microstructures and Vision in BRVO

To investigate the correlation of fundus autofluorescence (FAF) with the findings of spectral-domain optical coherence tomography (SD-OCT) and visual acuity in patients with branch retinal vein occlusion (BRVO) and to determine the visual prognostic factors, scientists conducted this study.

Retrospectively, they obtained an evaluation of FAF, SD-OCT images and visual acuity before and after intravitreal injection of bevacizumab (IVB) (pre- and post-IVB) was obtained in 42 patients with BRVO who underwent IVB as their first treatment. They also graded FAF of fovea on a scale of one to four.

The study scientists reported that the visual acuity post-IVB was associated with the visual acuity pre-IVB. Preservation of external limiting membrane and photoreceptor inner and outer segment junction pre- and post-IVB were associated with better visual acuity post-IVB. Furthermore, eyes with less FAF pre-IVB were closely associated with better visual acuity post-IVB.

To conclude, the shorter length of photoreceptor inner and outer segment junction and external limiting membrane defect and less FAF pre-IVB showed a significant association with better visual acuity post-IVB. These associations could help to predict potential restoration of photoreceptor integrity and visual recovery in patients with BRVO, in whom photoreceptor integrity before treatment could not be adequately evaluated, even with SD-OCT.

Source: Park B, Kim J, Chung H, Kim HC. Correlation of fundus autofluroescence with foveal microstructures and vision in branch retinal vein occlusion. Retina. 2014;34(3):531–538.


OCT Hyperreflective Foci and Visual Outcomes Following Intravitreal Bevacizumab for Macular Edema in BRVO

In the following study, the authors investigated the correlation between hyperreflective foci (HF) on spectral-domain optical coherence tomography (SD-OCT) at baseline and visual outcomes after intravitreal bevacizumab injection (IVB) in branch retinal vein occlusion (BRVO).

They retrospectively studied 97 eyes of 97 patients with macular edema secondary to BRVO, who were treated with IVB, and divided the eyes into three groups according to the location of HF on SD-OCT: HF in outer retinal layers; HF in inner retinal layers; and no HF. The baseline and final best-corrected visual acuity (BCVA), foveal thickness (FT), external limiting membrane (ELM) status, junction between photoreceptor inner and outer segments (IS/OS) status, and the number of HF were evaluated and compared among three groups.

The authors noted that baseline BCVA was correlated with baseline FT (R=0.366, p<0.001), but final BCVA was not correlated with final FT (R=–0.008, p=0.942). They also reported that baseline BCVA was significantly better in eyes with intact ELM at baseline (p=0.006), and final BCVA was significantly better in eyes with intact ELM and IS/OS at final visit (p<0.001, p=0.003 respectively). At the final visit, the authors observed that 15 of 37 eyes (40.5%) with HF in outer retinal layers had a disrupted ELM (p=0.001), while 28 of 37 eyes (75.7%) with HF in outer retinal layers had a disrupted IS/OS (p< 0.001). Final BCVA was poorer in eyes with HF in outer retinal layers groups than those in the other two groups (p< 0.001), although baseline BCVA was not different between them.

HF on SD-OCT at baseline might predict the photoreceptor status and final VA after IVB in BRVO.

Source: Kang JW, Lee H, Chung H, Kim HC. Correlation between optical coherence tomographic hyperreflective foci and visual outcomes after intravitreal bevacizumab for macular edema in branch retinal vein occlusion. Graefes Arch Clin Exp Ophthalmol. 2014; March [Epub ahead of print]. DOI: 10.1007/s00417-014-2595-5.


A Closer Look at Mortality in Patients with CRVO

Danish investigators sought to assess mortality in patients with central retinal vein occlusion (CRVO) by conducting this registry-based cohort study.

The study consisted of 439 photographically verified CRVO patients and a control cohort of 2,195 unexposed subjects matched by age and gender and alive on the date CRVO was diagnosed in the corresponding case. The investigators used data from nationwide registries to compare mortality rates in CRVO patients with a control cohort over a mean follow-up of 5.1 years for cases and of 5.7 years for controls. Main outcome measures were hazard ratios (HRs) obtained by Cox regression and standardized mortality ratios (SMRs) stratified by age and gender served as measures of relative mortality risk.

The investigators reported that mortality was higher in patients with CRVO (HR, 1.45; 95% confidence interval [CI], 1.19 to 1.76) than in the control cohort, adjusted for age, gender and time of diagnosis. They also found that mortality was comparable between the two groups (HR, 1.19; 95% CI, 0.96 to 1.46) when adjusting for overall occurrence of cardiovascular disease and diabetes. Subgroup analysis found that the age-stratified mortality rate was increased significantly in the total group of men (SMR, 1.27; 95% CI, 1.03 to 1.56) and in women 60 to 69 years of age (SMR, 1.94; 95% CI, 1.22 to 3.08).

In conclusion, CRVO was associated with an overall increase in mortality compared with controls that was attributed statistically to cardiovascular disorders and diabetes. The investigators recommend treatment of hypertension and diabetes, if present, and referral of patients found to have CRVO who are not already being treated by a primary-care physician.

Source: Bertelsen M, Linneberg A, Christoffersen N, et al. Mortality in patients with central retinal vein occlusion. Ophthalmol. 2014;121(3):637–642.


Impact of Thyroid Hormone Signaling Suppression on Cone Photoreceptors in Retinal Degeneration

Cone phototransduction and survival of cones in the human macula are essential for color vision and for visual acuity. Progressive cone degeneration in age-related macular degeneration, Stargardt's disease, and recessive cone dystrophies is a major cause of blindness. Thyroid hormone (TH) signaling, which regulates cell proliferation, differentiation and apoptosis, plays a central role in cone opsin expression and patterning in the retina.

Here, researchers investigated whether TH signaling affects cone viability in inherited retinal degeneration mouse models. They used retinol isomerase RPE65-deficient mice (a model of Leber's congenital amaurosis [LCA] with rapid cone loss) and cone photoreceptor function loss type 1 mice (severe recessive achromatopsia) to determine whether suppressing TH signaling with anti-thyroid treatment reduces cone death. Further, they used cone cyclic nucleotide-gated channel B subunit-deficient mice (moderate achromatopsia) and guanylate cyclase 2e-deficient mice (LCA with slower cone loss) to determine whether triiodothyronine (T3) treatment (stimulating TH signaling) causes deterioration of cones.

The study researchers found that cone density in retinol isomerase RPE65-deficient and cone photoreceptor function loss type 1 mice increased about sixfold, following anti-thyroid treatment. Additionally, cone density in cone cyclic nucleotide-gated channel B subunit-deficient and guanylate cyclase 2e-deficient mice decreased about 40% following T3 treatment.

To conclude, the effect of TH signaling on cone viability appears to be independent of its regulation on cone opsin expression. This work demonstrates that suppressing TH signaling in retina dystrophy mouse models is protective of cones, providing insights into cone preservation and therapeutic interventions.

Source: Ma H, Thapa A, Morris L, et al. Suppressing thyroid hormone signaling preserves cone photoreceptors in mouse models of retinal degeneration. Proc Natl Acad Sci U S A. 2014; Jan 24. [Epub ahead of print]. DOI: 10.1073/pnas.1317041111.




 



QLT Reports Positive Preliminary Results from Phase Ib Retreatment Trial of QLT09001

QLT Inc. announced positive preliminary results from its international, multicenter, open-label Phase Ib clinical trial of repeated treatments of oral QLT091001 in subjects with Leber's congenital amaurosis (LCA) or retinitis pigmentosa (RP) due to inherited genetic mutations in retinal pigment epithelium (RPE65) or lecithin:retinol acyltransferase (LRAT). The proof-of-concept trial was an extension study in which LCA or RP subjects with RPE65 or LRAT mutations who had been previously treated with a single course of QLT091001 in the company's previously completed Phase Ib study, received up to three seven-day courses of QLT091001 to assess visual outcomes and safety following retreatment. Preliminary results of the study show clinically meaningful improvements in visual fields (VF) and visual acuity (VA). To date, 19 of 27 subjects (70%) had an increase in VF retinal area from baseline of ≥ 20% in at least one eye at two consecutive visits within six months from the start of any QLT091001 treatment course. Plus, 70% of subjects had an increase in VA from baseline of five or more letters in at least one eye at two consecutive visits within six months from the start of any treatment course. The final clinical data, including the duration of response and other evaluations, are anticipated for release in the third quarter of 2014.

Source: QLT Inc., February 2014.




Enrollment Begins in Wet AMD Study

In 2013, Moorfields and SalutarisMD announced their collaboration to advance the research and development of a novel medical device for use in the treatment of wet age-related macular degeneration (AMD). Now, enrollment has begun in a Salutaris Medical Devices Ltd.-sponsored observational study (“A Prospective Study to Determine Choroidal and Scleral Depth in Subjects with Neovascular Age-related Macular Degeneration Receiving Anti-VEGF Therapy”) conducted at Moorfields Eye Hospital NHS Foundation Trust to accurately measure the scleral and choroid thickness at the fovea and at the choroidal neovascular lesion. The SalutarisMD device employs a minimally invasive retrobulbar episcleral brachytherapy application to the neovascular membranes. The study will use three imaging modalities to determine the depth from the retrobulbar episcleral surface to the vitreous side of the sclera, choroid and retina at the center of the fovea and choroidal neovascularization. Enrollment of study subjects is ongoing. Read more at salutarismd.com.

Source: Salutaris Medical Devices Ltd., February 2014.




ThromboGenics Plans to Begin Phase IV Study of Jetrea

ThromboGenics NV will soon initiate a prospective, observational Phase IV study with Jetrea to generate further data on the real-world use of the drug. The Ocriplasmin Research to Better Inform Treatment (ORBIT) study will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) across 120 retina centers in the United States. The study will assess clinical outcomes and safety of Jetrea administered in a real-world setting for the treatment of symptomatic VMA/VMT by assessing both anatomical and functional outcomes. Patients will be followed for up to 12 months after treating with Jetrea. Patient recruitment is expected to begin this month. For additional information, visit www.thrombogenics.com.

Source: ThromboGenics NV, March 2014.




FDA Accepts Eylea Injection sBLA for the Treatment of Macular Edema Following BRVO, Bayer HealthCare and Regeneron Announce Regulatory Submission of Eylea Injection for the Treatment of DME in Japan

The FDA has accepted for standard review Regeneron Pharmaceutical's supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion (BRVO). The submission in this indication is based on the positive results from the double-masked, randomized, active-controlled Phase III VIBRANT trial of 183 patients with macular edema following BRVO. Regulatory submissions have also been made in the United States and the European Union for Eylea for the treatment of diabetic macular edema (DME). Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share the profits equally, with the exception of Japan, where Regeneron receives a percentage of net sales.

In related news, Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin Ltd., has submitted an application for marketing authorization for Eylea Injection for the treatment of patients with DME to the Japanese Ministry of Health, Labour and Welfare. This submission is based on data from the VISTA-DME, VIVID-DME and VIVID-Japan studies, in which Eylea was generally well-tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs and non-ocular serious AEs across the treatment groups and the laser control group.

For additional details on both news items, click here.

Source: Regeneron Pharmaceuticals Inc., February and March 2014.




Santen and Tracon Agree to Develop and Commercialize TRC105

Tracon Pharmaceuticals and Santen Pharmaceutical Co., Ltd. have entered into an exclusive agreement for the development and global commercialization of Tracon's anti-endoglin antibodies, including TRC105, a novel, first-in-class, clinical stage antibody to endoglin (CD105), an endothelial cell receptor that is essential for the process of angiogenesis, in ophthalmology. Under the terms of the agreement, Santen will make a $10 million up-front payment and certain milestone payments to Tracon in the development phase, and will pay commercialization milestone and tiered royalties on global sales of TRC105 in ophthalmology. Additionally, Santen will fund 100% of all global development, and commercialization activities, including the initiation of IND-enabling studies. Tracon will continue ongoing Phase II development of TRC105 in a number of oncology indications, and will retain global rights on application of its anti-endoglin antibody portfolio outside of ophthalmology. Read more here.

Source: Tracon Pharmaceuticals, March 2014.




 

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