Volume 10, Number 7
July 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.



Positive Regulatory Outcome Reported for Iluvien
Alimera Sciences Inc. recently announced the positive outcome of the Repeat-Use Procedure for Iluvien intravitreal implant...

Allergan R&D Pipeline Update; FDA Approves Ozurdex
Allergan Inc. has reported updates on its key R&D pipeline programs, including abicipar pegol (Anti-VEGF Darpin) and bimatoprost sustained-release implant for glaucoma...

And More...

Injection With Intravitreal Aflibercept for Macular Edema Caused by CRVO

To evaluate the efficacy and safety of intravitreal aflibercept injection for the treatment of macular edema secondary to central retinal vein occlusion, the following randomized, double-masked, Phase III trial was performed.

It included 188 patients with macular edema secondary to CRVO. Patients received IAI 2 mg (IAI 2Q4) (n=114) or sham injections (n=74) every four weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI as needed, or pro re nata (IAI 2Q4 + p.r.n. and sham + IAI p.r.n.). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI p.r.n. The primary efficacy end point was the proportion of patients who gained ≥15 letters in best-corrected visual acuity from baseline to week 24. This study reports week 100 results.

The proportion of patients gaining ≥15 letters was 56.1% vs. 12.3% (p<0.001) at week 24, 55.3% vs. 30.1% (p<0.001) at week 52, and 49.1% vs. 23.3% (p<0.001) at week 100 in the IAI 2Q4 + p.r.n. and sham + IAI p.r.n. groups, respectively. The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + p.r.n. group compared with the sham + IAI p.r.n. group at week 24 (+17.3 vs. –4.0 letters; p<0.001), week 52 (+16.2 vs. +3.8 letters; p<0.001), and week 100 (+13.0 vs. +1.5 letters; p<0.0001). The mean reduction from baseline in central retinal thickness was 457.2 vs. 144.8 µm (p<0.001) at week 24, 413.0 vs. 381.8 µm at week 52 (p=0.546), and 390.0 vs. 343.3 µm at week 100 (p=0.366) in the IAI 2Q4 + p.r.n. and sham + IAI p.r.n. groups, respectively. The mean number (standard deviation) of p.r.n. injections in the IAI 2Q4 + p.r.n. and sham + IAI p.r.n. groups was 2.7 ± 1.7 vs. 3.9 ± 2.0 during weeks 24 to 52 and 3.3 ± 2.1 vs. 2.9 ± 2.0 during weeks 52 to 100, respectively. The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage (0.9% vs. 6.8% in the IAI 2Q4 + p.r.n. and sham + IAI p.r.n. groups, respectively).

To conclude, the visual and anatomic improvements after fixed dosing through week 24 and p.r.n. dosing with monthly monitoring from weeks 24 to 52 were diminished after continued p.r.n. dosing, with a reduced monitoring frequency from weeks 52 to 100.

Source: Heier JS, Clark WL, Boyer DS, et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS Study. Ophthalmology. 2014;121(7):1414–1420.


Sporadic Visual Acuity Loss During Anti-VEGF Treatment for Neovascular AMD

To evaluate transient, large visual acuity decreases, termed sporadic vision loss, during anti-vascular endothelial growth factor treatment for neovascular age-related macular degeneration, investigators created a cohort within a randomized clinical trial (Comparison of Age-Related Macular Degeneration Treatments Trials).

In total, they evaluated 1,185 CATT patients. Main outcome measures were the incidence of sporadic vision loss and odds ratio for association with patient and ocular factors. They reported that sporadic vision loss was a decline of ≥15 letters from the previous visit, followed by a return at the next visit to no more than five letters worse than the visit before the VA loss.

There were 143 sporadic vision loss events in 122 of 1,185 patients (10.3%), the investigators noted. They also observed that mean VA at two years for those with and without sporadic vision loss was 58.5 (~20/63) and 68.4 (~20/40) letters, respectively (p<0.001). Among patients treated pro re nata, no injection was given for 27.6% (27/98) of sporadic vision loss events. Multivariate analysis demonstrated that baseline predictors for sporadic vision loss included worse baseline VA (OR 2.92, 95% confidence interval [CI]: 1.65 to 5.17 for ≤20/200 compared with ≥20/40), scar (OR 2.21, 95% CI: 1.22 to 4.01), intraretinal foveal fluid on optical coherence tomography (OR 1.80, 95% CI: 1.11 to 2.91) and medical history of anxiety (OR 1.90, 95% CI: 1.12 to 3.24) and syncope (OR 2.75, 95% CI: 1.45 to 5.22). Refraction decreased the likelihood of sporadic vision loss (OR 0.62, 95% CI: 0.42 to 0.91).

In conclusion, approximately 10% of CATT patients had sporadic vision loss. Baseline predictors included AMD-related factors and factors independent of AMD. These data are relevant for clinicians in practice and those involved in clinical trials.

Source: Kim BJ, Ying GS, Huang J, et al., on behalf of the CATT Research Group. Sporadic visual acuity loss in the comparison of age-related macular degeneration treatments trials (CATT). Am J Ophthalmol. 2014;158(1):128–135.


Exacerbation of RPE and Choroidal Atrophy Following Treatment With Anti-VEGF in Neovascular AMD

Researchers studied the progression of retinal pigment epithelium and choroidal atrophy in patients with neovascular age-related macular degeneration and assessed for a possible association with the number and type of anti-vascular endothelial growth factor treatments.

They reviewed patients with neovascular AMD and a minimum of one-year follow-up. They used fellow eyes with non-neovascular AMD as control eyes and determined retinal pigment epithelial atrophy area and choroidal thickness using spectral-domain optical coherence tomography. Moreover, they used multivariable regression models for statistical analyses.

The study researchers noted that 415 eyes were included in the study, with a mean follow-up of 2.2 years. They also reported that eyes with neovascular AMD had greater progression of RPE atrophy and choroidal atrophy compared with those with non-neovascular AMD (p<0.001). Progression of RPE atrophy and choroidal atrophy was independently associated with the total number of injections of bevacizumab and ranibizumab (all p values ≤ 0.001). In the subgroup of 84 eyes with neovascular AMD and without RPE atrophy at baseline, only bevacizumab was associated with the progression of RPE atrophy (p=0.003). This study likely lacked statistical power to detect an association with ranibizumab in this subgroup.

RPE atrophy and choroidal atrophy in neovascular AMD seem to be exacerbated by anti-VEGF treatment. Possible differences between bevacizumab and ranibizumab require further investigation.

Source: Young M, Chui L, Fallah N, et al. Exacerbation of chroidal and retinal pigment epithelial atrophy after anti-vascular endothelial growth factor treatment in neovascular age-related macular degeneration. Retina. 2014;34(7):1308–1315.


Link Between Retinal Microstructures on OCT and Microperimetry in AMD

The authors of this prospective, observational study sought to determine the relationship between structural parameters of the outer retina on spectral-domain optical coherence tomography and microperimetric retinal sensitivity in early stages of age-related macular degeneration.

They included 75 eyes of 75 participants with early stages of AMD (drusen ≥125 µm, with/without pigmentary abnormalities) and 25 control participants of a similar age.

Participants underwent microperimetry testing and high-resolution SD-OCT scans, the authors reported. They compared structural parameters at five central points (0°, 1° and 2.33° nasal and temporal to the fovea along the horizontal axis) corresponding to areas tested by microperimetry. Structural parameters included outer segment length, thickness and elevation of the retinal pigment epithelium band, grading of the inner-segment ellipsoid (ISe) band integrity and presence of hyperreflective foci. Relationship between structural parameters and retinal sensitivity was the main outcome measure.

According to the authors, retinal sensitivity was significantly correlated with RPE elevation (p<0.001), ISe grading (p<0.001) and presence of HF (p≤ 0.018) at all test points, but not with OS length (p≥ 0.093) or RPE thickness (p≥ 0.125). However, multiple linear regression analyses revealed that only ISe grading (p≤ 0.011) and RPE elevation (p≤ 0.030) remained significantly associated with retinal sensitivity at all points. By using a simple linear model incorporating ISe grading and RPE elevation to predict values of retinal sensitivity, the 95% limits of agreement between the predicted and the actual value was ±3.83 dB.

The study authors determined that the integrity of the ISe band and drusen-associated RPE elevation are significant independent predictors of microperimetric retinal sensitivity. Their findings imply that these two structural parameters may be surrogate markers of retinal function in the early stages of AMD.

Source: Wu Z, Ayton LN, Guymer RH. Relationship between retinal microstructures on optical coherence tomography and microperimetry in age-related macular degeneration. Ophthalmology. 2014;121(7):1445–1452.


Subretinal Hyperreflective Exudation Associated With Neovascular AMD

To describe the multimodal imaging findings of subretinal hyperreflective exudation observed in association with choroidal neovascularization and to distinguish SHE from other forms of subretinal hyperreflective material seen in patients with age-related macular degeneration and other macular disorders, this retrospective study was performed.

It included 46 eyes of 42 patients with SHE associated with types one, two and three CNV secondary to neovascular AMD. Patients were examined using multimodal imaging, including color photography, near-infrared reflectance imaging, spectral-domain optical coherence tomography, fluorescein angiography, fundus autofluorescence imaging and indocyanine green angiography. Clinical and imaging characteristics were evaluated at baseline, after the initiation of intravitreal anti-vascular endothelial growth factor therapy, and during the resolution of SHE.

It was reported that 45 of the 46 eyes were treatment naïve and that the mean ± SD age at the first detection of SHE was 77.2 ± 10.1 years. Additionally, the mean ± SD follow-up was 2.1 ±0.6 years and FA was performed in 42 eyes and demonstrated leakage and/or staining of underlying or adjacent CNV, but not of the SHE itself in all eyes. On FA, SHE was transparent in 29 eyes and blocking in seven eyes. In 32 eyes, SHE showed isoautofluorescence on FAF imaging, and in eight eyes, SHE showed varying degrees of hyperautofluorescence. Indocyanine green angiography was performed in eight eyes and demonstrated hyperfluorescence of SHE in seven eyes. In eight eyes, SHE was the only evidence of neovascular activity. All eyes having follow-up (42 eyes) showed resolution of the subretinal material with partial or full reconstitution of the ellipsoid zone after a median of two injections range (one to 16 injections). Furthermore, subretinal hyperreflective exudation persisted for a median of nine weeks (range, four to 60 weeks) after the initiation of treatment. The mean visual acuity before treatment was 0.619 (20/83), and it improved to 0.380 (20/48) (p=0.03) after the resolution of SHE.

To conclude, subretinal hyperreflective exudation differs from other types of SHM based on the findings from multimodal imaging. This novel type of SHM likely represents a sign of active neovascular AMD distinct from subretinal fluid, hemorrhage, neovascular tissue, lipid, pigment hyperplasia, subretinal fibrosis and the SHM observed with acquired vitelliform lesions. Intravitreal anti-VEGF agents can be used to successfully resolve SHE, often resulting in better visual outcomes in eyes manifesting this form of exudation.

Source: Shah VP, Shah SA, Mrejen S, Freund KB. Subretinal hyperreflective exudation associated with neovascular age-related macular degeneration. Retina. 2014;34(7):1281–1288.


Multilayered PED in Neovascular AMD

The following retrospective, observational case series aimed to describe the spectral-domain optical coherence tomography findings in eyes with chronic fibrovascular pigment epithelial detachment receiving intravitreal anti-vascular endothelial growth factor therapy.

Participants consisted of patients with chronic fibrovascular PEDs receiving serial intravitreal anti-VEGF t herapy. Corresponding SD-OCT scans of chronic PEDs were studied in detail over multiple visits. The internal structure within the sub-PED compartment was analyzed, characteristic features were identified, and then correlated with visual outcome.

A total of 38 eyes of 34 patients with fibrovascular PEDs were included. Mean and median Snellen visual acuity was 20/50 (range, 20/20 to 20/400). Eyes received a mean of 28.2 intravitreal anti-VEGF injections (median, 23.0; range, three to 70) administered over a mean of 36.9 months (median, 37.5; range, six to 84). A fusiform, or spindle-shaped, complex of highly organized layered hyperreflective bands was noted within each PED. Additionally, 19 eyes demonstrated heterogenous, dilated, irregular neovascular tissue adherent to the undersurface of the retinal pigment epithelium. Twenty-five eyes demonstrated a hyporeflective cavity separating the choroidal neovascularization complex from the underlying choroid.

Chronic fibrovascular PEDs receiving serial anti-VEGF therapy demonstrate a characteristic fusiform complex of highly organized, layered, hyperreflective bands, termed a “multilayered PED,” which is often seen in conjunction with neovascular tissue adherent to the undersurface of the RPE monolayer. On the basis of previous histopathologic correlations, these bands may represent a fibrous tissue complex with contractile properties. An associated hyporeflective space, termed a “pre-choroidal cleft,” separates the fusiform complex from the underlying choroid and may be due to contraction, the exudation of fluid, or both. Many of these eyes maintain good visual acuity, presumably because the neovascular and cicatricial process is suppressed within the sub-RPE space by chronic anti-VEGF therapy, thus permitting the viability of the photoreceptor population through preservation of the RPE.

Source: Rahimy E, Freund KB, Larsen M, et al. Multilayered pigment epithelial detachment in neovascular age-related macular degeneration. Retina. 2014;34(7):1289–1295.


Prediction Model for Advanced AMD

The purpose of the following study was to develop a clinical eye-specific prediction model for advanced age-related macular degeneration. The Age-Related Eye Disease Study cohort, followed up for eight years, served as the training dataset, and the Blue Mountains Eye Study cohort, followed up for 10 years, served as the validation dataset.

The study consisted of 4,507 AREDS participants (contributing 1,185 affected vs. 6,992 unaffected eyes) and 2,169 BMES participants (contributing 69 affected vs. 3,694 unaffected eyes). Using Bayes' theorem in a logistic model, eight baseline predictors (age, sex, education level, race, smoking status, presence of pigment abnormality, soft drusen and maximum drusen size) were employed to devise and validate a macular risk scoring system (MRSS). Additionally, the performance of the MRSS was assessed by calculating sensitivity, specificity and the area under the receiver operating characteristic curve (i.e., c-index). Advanced AMD was the main outcome measure.

The internally validated c-indexAREDS (0.88; 95% confidence interval, 0.87 to 0.89) and the externally validated c-indexBMES (0.91; 95% CI, 0.88 to 0.95) suggested excellent performance of the MRSS. The sensitivity and specificity at the optimal macular risk score cutoff point of zero were 87.6% and 73.6%, respectively. An application for the iPhone and iPad also was developed as a practical tool for the MRSS.

The MRSS was developed and validated to provide satisfactory accuracy and generalizability. It may be used to screen patients at risk of developing advanced AMD.

Source: Chiu CJ, Mitchell P, Klein R, et al. A risk score for the prediction of advanced age-related macular degeneration: development and validation in 2 prospective cohorts. Ophthalmology. 2014;121(7):1421–1427.


Use of Aflibercept to Treat Patients With Exudative AMD Who Were Incomplete Responders to Multiple Ranibizumab Injections

In this prospective, open-label, single-arm clinical trial, scientists aimed to determine the efficacy of 2.0 mg aflibercept in the management of patients with recalcitrant exudative age-related macular degeneration.

They saw patients monthly and gave them mandatory 2.0 mg aflibercept at baseline, months one, two and four. They performed pro re nata retreatment at months three and five upon evidence of disease on spectral-domain optical coherence tomography. End point at month six: mean change in Early Treatment Diabetic Retinopathy Study best corrected visual acuity and central subfield thickness, mean number of aflibercept injections, percentage of p.r.n. injections required, patients with no fluid on SD-OCT and patients losing >15 letters.

At baseline, the scientists noted that 46 patients with a mean of 42 prior anti-vascular endothelial growth factor-A intravitreal treatments had a mean of 74.2 letters (Snellen equivalent 20/32) and mean CST of 347 µm. ETDRS letters remained stable throughout the trial; at month six, mean BCVA change was +0.2 letters (range –10 to +13, p=0.71). Anatomically, mean CST improved significantly from baseline at each study visit including –23.6 µm at month one and –27.3 µm at month six (p=0.018). Seventy-one of 90 (79%) possible p.r.n. injections were required and a mean of 5.6 aflibercept injections out of the maximum six were administered. Ten of 45 (22%) patients had no retinal fluid on SD-OCT at month six. No patient lost more than 15 letters.

The study scientists determined that aflibercept 2.0 mg treatment maintained mean visual acuity improvements previously achieved with high-dose 2.0-mg ranibizumab injections in recalcitrant wet AMD patients. Aflibercept 2.0 mg treatment led to significant anatomic improvement and was required monthly in most patients.

Source: Wykoff CC, Brown DM, Maldonado ME, Croft DE. Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial). Br J Ophthalmol. 2014;98(7):951–955.


Subfoveal Choroidal Thickness in RAP

In the study below, researchers investigated the subfoveal choroidal thickness in patients with retinal angiomatous proliferation. They found that eyes with RAP had a significantly thinner subfoveal choroid compared with normal eyes. Such morphologic features may be related to the pathologic mechanism of RAP.

In consecutive patients with RAP, the researchers retrospectively measured subfoveal choroidal thickness by the use of enhanced depth imaging spectral-domain optical coherence tomography in comparison with age-matched control subjects.

Included in the study were 19 eyes of 19 patients with RAP and 32 eyes of 32 control subjects. The study researchers found no significant differences between the eyes with RAP and the control eyes regarding age, gender, spherical equivalent and axial length. They noted that mean subfoveal choroidal thickness in 19 eyes with RAP was significantly less than that in the control eyes (129.5 ± 35.8 µm vs. 201.3 ± 55.0 µm, p<0.0001). The difference in mean subfoveal choroidal thickness between eyes with Stage II RAP (132.8 ± 38.2 µm) and eyes with Stage III RAP (126.4 ± 36.6 µm) was not significant, they observed, though each measurement was significantly less than that in the control eyes (p<0.001 and p=0.002, respectively).

Source: Yamazaki T, Koizumi H, Yamagishi T, Kinoshita S. Subfoveal choroidal thickness in retinal angiomatous proliferation. Retina. 2014;34(7):1316–1322.


RNFL Thinning in Glaucoma Suspect Eyes

The authors of this prospective, observational cohort study compared the rates of retinal nerve fiber layer loss in patients suspected of having glaucoma who developed visual field damage with those who did not develop VFD and aimed to determine whether the rate of RNFL loss can be used to predict the development of VFD.

Participants consisted of glaucoma suspects, defined as having glaucomatous optic neuropathy or ocular hypertension (intraocular pressure, >21 mmHg) without repeatable VFD at baseline, from the Diagnostic Innovations in Glaucoma Study and the African Descent and Glaucoma Evaluation Study.

The authors measured global and quadrant RNFL thickness with spectral-domain optical coherence tomography (Spectralis HRA+OCT, Heidelberg Engineering). They defined visual field damage as having three consecutive abnormal visual fields. They also compared the rate of RNFL loss in eyes developing VFD to eyes not developing VFD using multivariate linear mixed-effects models. Furthermore, a joint longitudinal survival model used the estimated RNFL thickness slope to predict the risk of developing VFD, while adjusting for potential confounding variables. The rate of RNFL thinning and the probability of developing VFD were the main outcome measures.

Four hundred fifty-four eyes of 294 glaucoma suspects were included, the authors reported. They noted that the average number of SD-OCT examinations was 4.6 (range, two to nine), with median follow-up of 2.2 years (0.4 to 4.1 years). They also observed that 40 eyes (8.8%) developed VFD. The estimated mean rate of global RNFL loss was significantly faster in eyes that developed VFD compared with eyes that did not develop VFD (–2.02 µm/year vs. –0.82 µm/year; p<0.001). The joint longitudinal survival model showed that each 1-μm/year faster rate of global RNFL loss corresponded to a 2.05-times higher risk of developing VFD (hazard ratio, 2.05; 95% confidence interval, 1.14 to 3.71; p=0.017).

According to the study authors, the rate of global RNFL loss was more than twice as fast in eyes that developed VFD than in eyes that did not develop VFD. A joint longitudinal survival model showed that a 1-µm/year faster rate of RNFL thickness loss corresponded to a 2.05-times higher risk of developing VFD. These results suggest that measuring the rate of SD-OCT RNFL loss may be a useful tool to help identify patients who are at a high risk of developing visual field loss.

Source: Miki A, Medeiros FA, Weinreb RN, et al. Rates of retinal nerve fiber layer thinning in glaucoma suspect eyes. Ophthalmology. 2014;121(7):1350–1358.


Brimonidine's Effect on Retinal Vascular Autoregulation and Short-Term Visual Function in NTG

Investigators performed this nonrandomized, prospective clinical trial to assess whether brimonidine 0.15% alters retinal vascular autoregulation and short-term visual function in normal-tension glaucoma patients who demonstrate retinal vascular dysregulation.

In this study, 46 NTG patients not previously treated with brimonidine underwent retinal vascular autoregulation testing and visual function assessment using frequency doubling technology perimetry and equivalent noise motion sensitivity testing. The study investigators measured blood flow in a major temporal retinal artery with subjects seated and then while reclined for 30 minutes. They classified patients having a change in retinal blood flow with posture change outside the range previously found in healthy subjects as having retinal vascular dysregulation. They then treated these patients with brimonidine 0.15% for eight weeks and designated them for retesting.

The investigators noted that 23 patients demonstrated retinal vascular dysregulation at the initial visit. Younger age (p=0.050) and diabetes (p=0.055) were marginally significant risk factors for retinal vascular dysregulation. After the eight-week course with brimonidine, 14 of the 17 patients who completed the study showed a return of posture-induced retinal blood flow changes to levels consistent with normal retinal vascular autoregulation (p<0.0001). No significant changes in frequency doubling technology perimetry or in motion detection parameters were found following treatment with brimondine (p>0.09 for all tests performed).

Brimonidine significantly improved impaired retinal vascular autoregulation in NTG patients, but short-term alteration in visual function could not be demonstrated.

Source: Feke GT, Bex PJ, Taylor CP, et al. Effect of brimonidine on retinal vascular autoregulation and short-term visual function in normal tension glaucoma. Am J Opthalmol. 2014;158(1):105–112.




 



Positive Regulatory Outcome Reported for Iluvien

Alimera Sciences Inc. recently announced the positive outcome of the Repeat-Use Procedure for Iluvien intravitreal implant for the treatment of chronic diabetic macular edema in an additional 10 European Union countries. Alimera submitted the application through the Mutual Recognition Procedure with the Medicines and Healthcare products Regulatory Agency of the United Kingdom serving as the Reference Member State. The regulatory process for these additional countries, consisting of Ireland, the Netherlands, Belgium, Luxembourg, Sweden, Denmark, Finland, Norway, Poland and the Czech Republic, will now enter the national phase, in which each country grants marketing authorization. Iluvien will be indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.

Source: Alimera Sciences Inc., June 2014.




Allergan R&D Pipeline Update; FDA Approves Ozurdex

Allergan Inc. has reported updates on its key R&D pipeline programs, including abicipar pegol (Anti-VEGF Darpin) and bimatoprost sustained-release implant for glaucoma. The topline analysis of data from the Stage III, Phase II study of Darpin in neovascular age-related macular degeneration has been completed, and based on these and other data, the FDA supports Allergan's decision to advance Darpin to Phase III clinical trials. The data from Allergan’s Phase II clinical trials of bimatoprost sustained-release implant suggest that its efficacy is comparable to daily topical bimatoprost with a duration of four to six months. The FDA is also supportive of the company's decision to advance the implant to Phase III clinical trials. Allergan also announced that it has received approval from the FDA for Oxurdex (dexamethasone intravitreal implant) 0.7 mg as a treatment option for diabetic macular edema in adult patients who have an artificial lens implant or who are scheduled for cataract surgery.

Source: Allergan, June 2014.




Eylea Injection Submitted for European Marketing Authorization for Treatment of Macular Edema Secondary to BRVO

Regeneron Pharmaceuticals Inc. and Bayer HealthCare have announced that Bayer HealthCare has submitted an application to the European Medicines Agency seeking marketing authorization in the European Union for Eylea (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion. The EMA submission is based on the positive Phase III, double-masked, randomized, active-controlled VIBRANT trial of patients with macular edema following BRVO.

Source: Regeneron Pharmaceuticals Inc., June 2014.




Nicox and Sequenom Announce National Brand Launch of RetnaGene Test Portfolio in the United States

Nicox S.A.'s subsidiary, Nicox Inc., is conducting a national brand launch to Sequenom Laboratories' RetnaGene portfolio of two laboratory-developed genetic tests in the United States. The portfolio includes RetnaGene AMD and RetnaGene LR, tests performed exclusively by Sequenom that assess an individual's risk for advanced age-related macular degeneration. Sequenom granted Nicox exclusive promotion and marketing rights for its RetnaGene tests in January 2014, and Nicox has significantly strengthened its field force to support the national commercial launch of the portfolio, which is now available to U.S. customers. Practitioners can obtain additional information by calling (855) 696-4269 or by visiting www.mynicox.com.

Source: Nicox Inc., June 2014.




Researchers Create Mini Light-Sensing Retina

Researchers at Johns Hopkins recently reported that they have created a 3-D complement of human retinal tissue in the laboratory, which includes functioning photoreceptor cells capable of responding to light. The achievement emerged from experiments with human-induced pluripotent stem cells and could eventually enable genetically engineered retinal cell transplants that halt or even reverse a patient's march toward blindness, the researchers say. Read the online article in the journal Nature Communications.

Source: Johns Hopkins Medicine, June 2014.




Interim Top-Line Clinical Results Announced from Phase II Study of Squalamine Eye Drops for Wet AMD

Ohr Pharmaceuticals recently announced positive top-line interim results for its randomized, double-masked, placebo-controlled Phase II clinical trial (Study OHR-002) of squalamine eye drops used in combination with Lucentis p.r.n. for the treatment of wet age-related macular degeneration. The data failed to show a reduction in the number of injections, but suggested a positive benefit in visual function across multiple clinically relevant endpoints, including a mean change in visual acuity at the end of study visit for the interim analysis group of +10.4 letters with squalamine eye drops plus Lucentis p.r.n. versus +6.3 letters in the placebo eye drops plus Lucentis p.r.n. arm, a 65% additional relative benefit (p=0.18). The squalamine-treated group demonstrated improved best-corrected visual acuity gains relative to the placebo group at all time points evaluated from four to 38 weeks. Ohr plans to present the full data from this interim analysis in the second half of this year, with final clinical trial data expected in the first quarter of 2015.

Source: Ohr Pharmaceuticals, June 2014.




 

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