Volume 7, Number 11
November 2011


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.

FDA Rejects Alimera's NDA for Iluvien
Alimera Sciences, Inc. has received a complete response letter (CRL) from the FDA in response to the New Drug Application (NDA) for Iluvien for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy...

Injected Gene Therapy Being Studied for Treatment of Choroideremia
Work by researchers at the Ohio State University Medical Center and Nationwide Children's Hospital offer promise to people who suffer from choroideremia...

And More...

Resolved Retinal Fluid Following Intravitreal Ranibizumab for PCV

This Japanese study investigated the predictive factors for the resolution of retinal fluid after intravitreal injections of ranibizumab (IVRs) for polypoidal choroidal vasculopathy (PCV).

A total of 47 eyes of 45 patients with symptomatic PCV received 0.5 mg of IVR monthly for 3 months. One month after the third IVR, the presence of dry macula, defined as absence of retinal fluid as detected by the use of optical coherence tomography (OCT), was retrospectively evaluated and correlated with clinical characteristics at baseline. Most of the eyes were followed for more than 6 months.

Of the 47 eyes, 31 eyes (66%) achieved the dry macula along with increased best-corrected visual acuity (BCVA) (0.64 to 0.46 logarithm of the minimum angle of resolution (logMAR) units, p<0.0001), while the other 16 eyes without dry macula showed no significant change of BCVA. It was noted that univariate analyses of the baseline characteristics identified the smaller size of the largest polyp (p=0.0008) and the absence of serous or hemorrhagic pigment epithelial detachment (p=0.045) as predictive factors for the dry macula. Multivariate logistic regression found the independent predictor for the dry macula to be the smaller size of the largest polyp (p=0.001). Furthermore, no severe systemic or ocular adverse events were observed.

IVR may be helpful for resolution of retinal fluid and increased BCVA in the short term, but larger polyps and pigment epithelial detachments at baseline may be negative prognostic factors for a therapeutic response. Further studies are needed to clarify the long-term efficacy of IVR for PCV.

Source: Koizumi H, Yamagishi T, Yamazaki T, Kinoshita S. Predictive factors of resolved retinal fluid after intravtireal ranibizumab for polypoidal choroidal vasculopathy. Br J Ophthalmol. 2011;95(11):1555–1559.

Association of Elastin Gene Polymorphism to AMD and Polypoidal Choroidal Vasculopathy

In Japan, investigators genotyped five single nucleotide polymorphisms (SNPs), rs2301995, rs2856728, rs868005, rs884843 and rs13239907 at Kyoto University and Saitama Medical University to determine whether an association exists in Japanese between elastin gene polymorphisms and neovascular age-related macular degeneration (AMD) or its subtypes: typical AMD (tAMD) and polypoidal choroidal vasculopathy (PCV). They performed a case-control study on 1,296 patients with AMD and 478 controls.

They detected a statistically significant association between the rs2301995 SNP and AMD (p=0.018). The investigators reported that subtype analysis revealed a significant association of rs2301995 with tAMD (p=0.0018), but not with PCV. They noted that the genotype distribution of rs2301995 also differed significantly between tAMD and PCT (p=0.00030). They also found that the trend in genotype distribution of rs2301995 was similar between the Kyoto and the Saitama studies. Additionally, the A allele frequency was higher in tAMD while it was similar in PCV and in controls, which is opposite to a previous report that A allele frequency is higher in PCV while it is similar in tAMD and in controls. Haplotype analysis also showed that elastin gene polymorphism is significantly associated with tAMD (p=0.0055), but not with PCV.

The elastin gene is associated with AMD in Japanese. The investigators' findings suggest that the elastin gene is a susceptibility gene for tAMD but not for PCV, which is opposite to a previous report that the elastin gene is the susceptibility gene for PCV but not for tAMD.

Source: Yamashiro K, Mori K, Nakata I, et al. Association of elastin gene polymorphism to age-related macular degeneration and polypoidal chroidal vasculopathy. Invest Ophthalmol Vis Sci. 2011;Oct. 14 [Epub ahead of print]. DOI : 10.1167/iovs.11-8205.

Evaluation of Type 2 CNV Using SD-OCT, ICGA AND FA

In an observational case series, Austrian scientists evaluated the diagnostic characteristics of type 2 (classic) choroidal neovascularizations (CNVs) secondary to age-related macular degeneration (AMD) using spectral-domain optical coherence tomography (SD-OCT), indocyanine green angiography (ICGA) and fluorescein angiography (FA).

Included in this study were 13 treatment-naïve eyes with type 2 CNV without an occult component. Main outcome measures were greatest horizontal dimension, based on the anatomic features of the neosvacular complex by SD-OCT (Spectralis; Heidelberg Engineering), ICGA and FA; retinal leakage area in late-phase FA and ICGA; and the area of retinal edema in SD-OCT. For direct comparison, the scientists manually overlaid ICGA and FA images on infrared plus SD-OCT images using VirtualDub and Paint.NET software. They measured greatest horizontal dimension using Image J software (National Institutes of Health).

The study scientists found that the mean greatest horizontal dimension of the neovascular complex and the retinal leakage area consistently were smaller on ICGA compared with the area of retinal edema on SD-OCT. According to the FA, the greatest horizontal dimension of early, well-demarcated hyperfluorescence was significantly smaller than the neovascular complex on SD-OCT. Furthermore, the greatest horizontal dimension of the retinal leakage area in late-phase FA consistently was smaller than the area of retinal edema on SD-OCT.

In classic CNV, ICGA and FA seem to underestimate the extension of the neovascular complex and the associated retinal pathologic features compared with SD-OCT imaging.

Source: Sulzbacher F, Kiss C, Munk M, et al. Diagnostic evaluation of type 2 (classic) choroidal neovascularization: optical coherence tomography, indocynanine green angiography, and fluorescein angiography. Am J Ophthalmol. 2011;152(5):799–806.

Enhancing Cell Survival on Bruch's Membrane in Eyes Affected by Age and AMD

Retinal pigment epithelium (RPE) derived from human embryonic stem cells (hES-RPE) and cultured fetal and aged adult RPE were seeded onto the inner collagenous layer of submacular Bruch's membrane (BM)-choroid-sclera explants generated from aged and age-related macular degeneration (AMD) human donor eyes to determine whether conditioned medium (CM) derived from bovine corneal endothelial cells (BCEC) can support transplanted cells on aged and AMD BM.

Paired explants were cultured in BCEC-CM or vehicle. Explants were harvested after 21 days in culture to assess cell behavior after attachment to BM was established. To assess whether sustained exposure to BCEC-CM was necessary for improved cell survival on BM, short exposure to BCEC-CM (3,7,14 days) was compared to 21-day exposure. Additionally, explants were harvested and evaluated by scanning electron (SEM) and light microscopy and extracellular matrix (ECM) deposition after exposure to BCEC-CM was evaluated following RPE removal after day-21 on tissue culture dishes or on BM.

It was determined that BCEC-CM significantly enhanced hES-RPE, fetal RPE and aged adult RPE survival on BM, regardless of submacular pathology. While shorter BCEC-CM exposure times showed significant improvement in cell survival compared to culture in CM vehicle, longer BCEC-CM exposure times were more effective. Moreover, it was reported that BCEC-CM increased RPE ECM deposition on tissue culture plastic and on BM.

The results of this study indicate that RPE survival is possible on AMD BM and offer a method that could be developed for enhancing transplanted cell survival on AMD BM. Increased ECM deposition may account for improved cell survival following culture in BCEC-CM.

Source: Sugino IK, Rapista A, Sun Q, et al. A method to enhance cell survival on Bruch’s membrane in eyes affected by age and age-related macular degeneration (AMD). Invest Ophthalmol Vis Sci. 2011;Oct. 28 [Epub ahead of print]. DOI: 10.1167/iovs.11-8400.

Anti-VEGF Monotherapy vs. Combination Treatment with PDT for Subfoveal CNV Secondary to Causes Other than AMD

To compare the visual outcomes and retreatment rates of monotherapy with intravitireal bevacizumab versus combination with photodynamic therapy (PDT) for choroidal neovascularization (CNV) secondary to causes other than age-related macular degeneration (AMD), researchers administered intravitreal bevacizumab to 17 patients and intravitreal bevacizumab combined with verteporfin PDT to 6 patients within 3 days. They administered additional bevacizumab if there was persistent fluorescein leakage or subretinal fluid on optical coherence tomography (OCT).

According to the researchers, the mean change in visual acuity was vision gain of 1.7 lines in the monotherapy group compared with 2.8 lines in the combination therapy group at 12-month follow up (p=0.45). They noted that at 12 months, 93% in the monotherapy group and 100% in the combination group lost <2 lines of vision (p=1.0); 36% gained >3 lines of vision in the monotherapy compared with 60% in the combination therapy group (p=0.60). The monotherapy group received a mean of 4.8 reinjections, while the combination group received 2.6 reinjections over 12 months (p=0.11). The study researchers also reported that a subgroup analysis of cases of CNV caused by pathologic myopia demonstrated a mean change in visual acuity of vision gain of +2.0 lines in the monotherapy group versus +2.3 lines in the combination therapy group (p=0.82) and a mean of 7.2 reinjections versus 2 in monotherapy and combination group, respectively (p=0.0498) at 12 months.

They found that the majority of patients had stabilization or improvement in vision in both treatment groups and that combination therapy with bevacizumab plus PDT showed lower retreatment rates in patients with myopia. According to the researchers, randomized clinical trials are necessary to confirm these findings.

Source: Chen L, Miller JW, Vavvas D, Kim IK. Anti-vascular endothelial growth factor monotherapy versus combination treatment with photodynamic therapy for subfoveal choroidal neovascularization secondary to causes other than age-related macular degeneration. Retina. 2011;31(10):2078–2083.

Low-Fluence PDT vs. Intravitreal Ranizibumab for Chronic CSC

The following prospective, randomized, single-center pilot study in Korea reported 6-month outcomes of a prospective, randomized study comparing the efficacy and safety between low-fluence photodynamic therapy (PDT) and intravitreal injections of ranibizumab in the treatment of chronic central serous chorioretinopathy (CSC).

A total of 16 eyes with chronic CSC were randomized to receive either low-fluence PDT or intravtireal injections of ranibizumab: 8 eyes in the low-fluence PDT group and 8 in the ranibizumab group. Rescue treatment was considered if subretinal fluid was sustained after completion of primary treatment: low-fluence PDT for the ranibizumab group and ranibizumab injection for the low-fluence PDT group. Main outcome measures were excess foveal thickness, resolution of subretinal fluid, choroidal perfustion on indocyanine green angiography and best-corrected visual acuity.

At 3 months, the mean excess foveal thickness was reduced from 74.1 ± 56.0 µm to –35.4 ± 44.5 µm in the low-fluence PDT group (p=.017) and from 26.3 ± 50.6 µm to –23.1 ± 56.5 µm in the ranibizumab group (p=.058). After a single session of PDT, it was noted that 6 eyes (75%) in the low-fluence PDT group achieved complete resolution of subretinal fluid and reduction of choroidal hyperpermeability, whereas 2 (25%) eyes in the ranibizumab group achieved this after consecutive ranibizumab injections. It was also reported that four eyes (50%) in the ranibizumab group underwent additional low-fluence PDT and accomplished complete resolution. At 3 months, significant improvement of best-corrected visual acuity (BCVA) was not demonstrated in the low-fluence PDT group (p=.075), whereas it was observed in the ranibizumab group (p=.012). However, the tendency toward improvement to BCVA was not maintained.

To conclude, in terms of anatomic outcomes, the effect of ranibizumab injections was not promising compared with that of low-fluence PDT.

Source: Bae SH, Heo JW, Kim C, et al. A randomized pilot study of low-fluence photodynamic therapy versus intravitreal ranibizumab for chronic central serous chorioretinopathy. Am J Ophthalmol. 2011;152(5):784–792.

Link Between Efficacy of Half-Dose PDT with ICGA and OCT Findings in the Treatment of CSC

The authors of this Italian observational case series sought to determine the efficacy of half-dose photodynamic therapy (PDT) in relation to indocyanine green angiography (ICGA) and optical coherence tomography (OCT) findings for treating chronic central serous chorioretinopathy (CSC).

They recruited 38 eyes of 37 patients with chronic CSC and symptoms for at least 6 months and performed PDT using half the normal dose of verteporfin. The authors noted that a total light energy of 50 J/cm² over 83 seconds was delivered to the area of choroidal hyperfluorescence as observed on ICGA. They assessed the resolution of the subretinal fluid and recurrence rates in relation to the different degrees of choroidal hyperfluorescence and the distribution of fluid in the neuroepithelium, namely subretinal fluid or posterior retinal cystoid degeneration.

The study authors reported that after half-dose PDT, a dry macula was obtained in 86.8% and 92.1% of the eyes at 1 month and at the last follow-up (14.2 ± 5.8 months) respectively. They observed that ICGA at baseline showed intermediate and intense hyperfluorescence in 39.4% and 60.5% of the eyes respectively. Also, that all eyes with intermediate hyperfluorescence had only subretinal fluid at OCT and a dry macula was obtained in 87% and 100% at 1 month and at the last follow-up after half-dose PDT. In the intense hyperfluorescence group, the authors found that 82.6% and 17.4% of the eyes had subretinal fluid only or both subretinal fluid and posterior retinal cystoid degeneration respectively. They noted that in the intense hyperfluorescence group with subretinal fluid only, a dry macula was obtained in 89.5% and 100% of the eyes at 1 month and at the last follow-up respectively. In the intense hyperfluorescence group with both subretinal fluid and posterior retinal cystoid degeneration, a dry macula was obtained in 75% and 25% of the eyes at 1 month and at the last follow-up respectively. Overall, of the 23 eyes with intense hyperfluorescence, 20 eyes (87%) had a dry macula starting from 1 month for the entire follow-up period.

The half-dose PDT success rate in eyes with chronic CSC depends also on the distribution of fluid in the neuroepithelium, the authors concluded. Half-dose PDT might not be effective or the recurrence rate might be high in eyes with posterior retinal cystoid degeneration.

Source: Nicolò M, Zoli D, Musolino M, Traverso CE. Association between the efficacy of half-dose photodynamic therapy with indocyanine green angiography and optical coherence tomography findings in the treatment of central serous chorioretinopathy. Am J Ophthalmol. Oct. 24 [Epub ahead of print]. DOI: 10.1016/j.ajo.2011.08.015.

Relationship Between Photopsias, Perceived Stress and Positive Mood in RP

Researchers measured the relationship between the occurrence of photopsias (spontaneous phosphenes) and retinitis pigmentosa (RP) subjects' level of vision, light exposure and psychosocial factors to attempt to confirm RP patients' previous reports of these associations.

A total of 36 RP subjects self-administered PC-based binocular visual acuity, contrast sensitivity and visual field tests at home twice a week, for 16 session in 2–3 months and after each session, subjects reported photopsias during the vision tests and completed questionnaires: Scale, and Positive and Negative Affect Schedules.

The study researchers found that across all subjects, photopsias occurred during 47% of sessions. They noted that five (14%) subjects never noted photopsias, while five others noted photopsias at every session. Two-thirds of subjects experienced photopsias frequently (>20% of sessions). On average, the odds of noticing photopsias increased by 57% for every 1-point increase in mean perceived stress (OR=1.57; 95% CI: 1.04, 2.4; p=0.03) or reduced by 38v for every 1-point increase in positive mood (OR=0.62; 95% CI: 0.39, 0.98; p=0.04), after adjusting for age, gender and vision. Similarly, the odds of experiencing photopsias during a session increased by 16% for every 3-point increase in perceived stress and decreased by 17% for every 3-point increase in positive mood, after adjusting for age and gender (OR=1.16; 95% CI: 1.01, 1.33; p=0.048) (OR=0.83; 95% CI: 0.73, 0.94; p=0.004), respectively. The researchers reported that frequency of photopsias was not statistically significantly related to other factors measured.

Increased photopsias appear to be related to times when subjects report increased perceived stress and/or decreased positive mood, rather than RP patients' age, level of vision, reported light exposure or sleepiness.

Source: Bittner AK, Haythornthwaite JA, Diener-West M, Dagnelie G. Photopsias are related in part to perceived stress and positive mood in retinitis pigmentosa. Eye. 2011; Oct. 14 [Epub ahead of print]. DOI: 10.1038/eye.2011.247.

Evaluation of Vascular Disease Progression of ROP

U.S. investigators measured accuracy and speed for detection of vascular progression in retinopathy of prematurity (ROP) from serial images in this prospective comparative study. They compared two strategies: static side-by-side presentation and dynamic flickering of superimposed image pairs.

They took 15 de-identified, wide-angle retinal image pairs from infants who eventually developed plus disease. They also took image pairs representing vascular disease progression ≥1 week apart and control images without progression on the same day and also created dynamic flickering pairs by digital image registration. Ten experts independently reviewed each image pair on a secure website using both strategies and were asked to identify progression or state that images were identical. The investigators measured accuracy and speed using examination date and ophthalmoscopic findings as a reference standard.

They determined that experts were accurate in a mean (%) ± standard deviation (SD) of 11.4 of 15 (76%) ± 1.7 image pairs using static images and that using dynamic flickering images, experts were accurate in a mean (%) ± SD of 11.3 of 15 (75%) ± 1.7 image pairs. The investigators found no significant difference in accuracy between these strategies (p=.420). They noted that diagnostic speed was faster using dynamic flickering (24.7 ± 8.3 seconds) vs static side-by-side images (40.3 ± 18.3 seconds) (p=.002). Experts reported higher confidence when interpreting dynamic flickering images (p=.001).

The study investigators found that retinal imaging provides objective documentation of vascular appearance, with potentially improved ability to recognize ROP progression compared to standard ophthalmoscopy. Speed of identifying vascular progression was faster by review of dynamic flickering image pairs than by static side-by-side images, although there was no difference in accuracy.

Source: Myung JS, Gelman R, Aaker GD, et al. Evaluation of vascular disease progression of retinopathy of prematurity using static and dynamic retinal images. Am J Ophthalmol. 2011;Oct. 24 [Epub ahead of print]. DOI: 10.1016/j.ajo.2011.08.030.

A Look at Macular Microcirculation in Patients with Epiretinal Membrane Before and After Surgery

The authors of the following Japanese study investigated blood flow velocity (BFV) in the perifoveal capillaries before and after vitreous surgery for patients with epiretinal membrane (ERM).

They included 21 eyes in patients with ERM and 16 eyes in healthy subjects and performed fluorescein angiography using a scanning laser ophthalmoscope. They also analyzed BFV by the tracing method and measured foveal thickness (FT) by optical coherence tomography (OCT).

The authors reported that BFV was significantly slower in the ERM patients (1.04 ± 0.10 mm/s) than in the healthy subjects (1.49 ± 0.11 mm/s) (p=0.0010). They noted that BFV in the ERM patients 6 months after vitreous surgery (6 m) (1.21 ± 0.02 mm/s) significantly increased compared with BFV before surgery (0 m) (1.04 ± 0.10 mm/s) (p=0.0061). BFV 1 year after vitreous surgery (1 y) significantly increased (1.38 ± 0.02 mm/s) compared with BFV (6 m) (1.21 ± 0.02 mm/s) (p=0.0235). According to the authors, FT was significantly greater in the ERM patients (351.7 ± 87.1 µm) than in the healthy subjects (158.9 ± 16.9 µm) (p=0.0011). They found that FT (6 m) significantly decreased (285.3 ± 36.9 µm) compared with FT before surgery (0 m) (351.7 ± 87.1 µm) (p=0.0212). FT did not show significant differences between (6 m) and (1 y). No significant correlation was found between BFV and FT before surgery.

In conclusion, perifoveal capillary BFV in patients with ERM was slower than that in the healthy subjects, and significantly improved after vitreous surgery as time progressed. It can be said that perifoveal capillary BFV is related to the development and improvement of ERM in the long term.

Source: Yagi T, Sakata K, Funatsu H, et al. Macular microcirculation in patients with epiretinal membrane before and after surgery. Graefes Arch Clin Exp Ophthalmol. 2011; Oct. 15 [Epub ahead of print]. DOI: 10.1007/s00417-011-1838-y.

Retinal Vessel Caliber in Patients with AIDS

In this longitudinal, observational cohort study, researchers evaluated relationships between retinal vessel caliber and tests of visual function among people with AIDS. They found that variation in retinal vascular indices is associated with abnormal visual function in people with AIDS, manifested by visual field loss and possibly by reduced contrast sensitivity (CS).

They evaluated data for participants without ocular opportunistic infections at initial examination (baseline) in the Longitudinal Studies of the Ocular Complications of AIDS (1998–2008). They also evaluated visual function with best-corrected visual acuity (BCVA), Goldmann perimetry, automated perimeter and CS testing. The researchers noted that semi-automated grading of fundus photographs (1 eye/participant) determined central retinal artery equivalent (CRAE), central retinal vein equivalent (CRVE) and arteriole-to-venule ratio (AVR) at baseline. Multiple linear regression models, using forward selection, sought independent relationships between indices and visual function variables.

A total of 1,250 participants were included and the researchers noted that smaller AVR was associated with reduced visual field by Goldmann perimetry (p=.003) and worse mean deviation (p=.02) on automated perimetry and possibly with worse pattern standard deviation (PSD) on automated perimetry (p=.06). They found that there was a weak association between smaller AVR and worse CS (p=.07). The study researchers also reported that relationships were independent of antiretroviral therapy and level of immunodeficiency (CD4+ T lymphocyte count, human immunodeficiency virus [HIV] RNA blood level. They observed that on longitudinal analysis, retinal vascular indices at baseline did not predict changes in visual function.

They concluded that relationships are consistent with the hypothesis that HIV-related retinal vasculopathy is a contributing factor to vision dysfunction among HIV-infected individuals and that longitudinal studies are needed to determine whether changes in indices predict change in visual function.

Source: Kalyani PS, Fawzi AA, Gangaputra S, et al. Retinal vessel caliber among people with acquired immunodeficiency syndrome: relationships with visual function. Am J Ophthalmol. 2011;Oct. 24 [Epub ahead of print].

FDA Rejects Alimera's NDA for Iluvien

Alimera Sciences, Inc. has received a complete response letter (CRL) from the FDA in response to the New Drug Application (NDA) for Iluvien for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy. In the letter, the FDA stated that it was unable to approve the Iluvien NDA because the NDA did not provide sufficient data to support that Iluvien is safe and effective in the treatment of patients with DME. The FDA stated that the risks of adverse reactions shown for Iluvien in the FAME Study were significant and were not offset by the benefits demonstrated by Iluvien in these clinical trials. Additionally, the agency has indicated that Alimera will need to conduct two additional clinical trials to demonstrate that the product is safe and effective for the proposed indication. In a recent press release, Alimera shared that it will be requesting a meeting with the FDA to clarify the next steps.

Source: Alimera Sciences, Inc., November 2011.

Injected Gene Therapy Being Studied for Treatment of Choroideremia

Work by researchers at the Ohio State University Medical Center and Nationwide Children's Hospital offer promise to people who suffer from choroideremia. They have developed a viral vector to deliver a gene into the eyes of people born with this inherited, progressive form of blindness that mainly affects males. The vector is part of a clinical trial being conducted by researchers at the University of Oxford in England that is investigating the use of gene therapy to cure choroideremia. The trial involves 12 patients, who will receive treatment in one eye and should take 24 months to know whether the gene-therapy treatment has stopped the degeneration in light-sensitive photoreceptor cells caused by the disease. Learn more about the researchers involved and about the development of the vector by clicking here.

Source: The Ohio State University Medical Center, November 2011.

Allegro Ophthalmics Completes Phase 1 Study, Presents Key Data on Integrin Peptide Therapy

Allegro Ophthalmics, LLC, has completed its Phase 1 human study on Integrin Peptide Therapy and presented the study's data at the American Academy of Ophthalmology's 2011 retina subspecialty meeting. The Phase 1, open-label, single dose study focused on determining safety and initial efficacy of integrin peptide therapy, which is an emerging new class of treatment for vascular eye diseases. All enrolled patients suffered from advanced stage diabetic macular edema (DME), with visual acuity of 20/100 or worse and many were refractory to current treatment options and exhibited the onset of diabetic retinopathy. Results showed that more than 50% of the patients in the trial demonstrated three to five lines of BCVA improvement after 90 days, and a definitive improvement in OCT central macula thickness. Allegro says that the clinical benefit lasted until the end of the trial, equating to 90 days off-treatment. Additionally, patients who did not respond to treatment did not experience any disease progression during the trial. Read more at Allegro's website.

Source: Allegro Ophthalmics, LLC, October 2011.

Wilmer Eye Institute Receives Grant for Integrin Peptide Therapy

In a recent press release, Allegro Ophthalmics, LLC reported that its research collaboration with The Wilmer Eye Institute at Johns Hopkins has received a grant in excess of $600,000 from the Leona M. and Harry B. Helmsley Charitable Trust to further the development of the company's new Integrin Peptide Therapy for the treatment of diseases such as retinopathy, diabetic macular edema and wet age-related macular degeneration. Integrin Peptide Therapy is a very small molecule that is capable of binding the parts of the eye responsible for the production of abnormal blood vessels and works upstream to shut off the production of these blood vessels.

Source: Allegro Ophthalmics, LLC, October 2011.

Carl Zeiss Announces New Technologies and Partnership

At the recent American Academy of Ophthalmology Annual Meeting in Orlando, Carl Zeiss Meditec unveiled new clinical and productivity tools across the glaucoma, retina, cataract and refractive workplaces. The new FORUM LINK Tools for the company's eye care data management system offers greater connectivity by allowing data integration of non-DICOM-compliant instruments with the benefits of a DICOM workflow. FORUM, together with an EHR system, combines image and practice management software for a complete, centralized, paperless record of diagnostic images, patient history and demographics. Carl Zeiss Meditec also introduced a partnership with Dr. Jack Holladay, creator of the Holladay 2 formula, and will enable the company to incorporate the 4th-generation Holladay 2 formula inside its IOLMaster 500.

Source: Carl Zeiss Meditec, October 2011.

New 3D Imaging Camera Available from Kowa

The new Kowa Optimed nonmyd WX3D Retinal Camera lets you take 3D images of the optic nerve with only a single flash per eye, which can save time with every examination, says the company. The nonmyd WX3D also integrates the latest simultaneous stereoscopic photography (SSP) with Kowa's proven normal and small pupil settings and a 9-point internal fixation system allows auto mosaic imaging good for up to 120 degrees of coverage. Furthermore, it is EHR interface ready and works with Kowa's Viewing Solution, allowing data to be quickly viewed, compared, organized, annotated and shared. Learn more at www.kowa-usa.com.

Source: Kowa Optimed, Inc., October 2011.

Ellex Unveils New All-in-One Laser/Slit Lamp Photocoagulator

Ellex Medical Lasers Limited announced that it would introduce an innovative laser platform, the Integre Pro, for the treatment of retinal disease at the latest meeting of the American Academy of Ophthalmology. Ellex says that the system is the first photocoagulation laser to offer customized configuration of multiple laser wavelengths in a fully integrated, laser/slip lamp (microscope) design, which will enable ophthalmologists to perform both diagnosis and treatment. The company also says that the Integre Pro has integrated the laser with the slit lamp microscope, unlike competitive systems, which require the adaptation of an external slip lamp microscope for the ophthalmologist to perform treatment. Read more about the Integre Pro here.

Source: Ellex Medical Lasers Limited, October 2011.

Optos Introduces Daytona Retinal Imager

Optos plc recently unveiled Daytona, the newest member of its family of ultra-widefield retinal imaging devices. Like its predecessors in the Optos family, Daytona provides an unequaled 200° view of the retina in a single capture through its patented Virtual Point technology. The company says that it is comparable to the P200C image quality and offers a range of premium features to support optometrists in the management of wellness patients and those with ocular disease. Daytona has been scaled to accommodate smaller office spaces while providing ultra-high resolution imaging and also includes new cutting-edge options such as ultra-widefield auto-fluorescence. Optos received 510(k) clearance from the FDA to market Daytona in August 2011 and will begin shipping the device in early 2012.

Source: Optos plc, October 2011.

Thrombrogenics Receives EMA Acceptance for Review of Marketing Authorization Application for Ocriplasmin

The European Medicines Agency (EMA) has accepted for review ThromboGenics NV's Marketing Authorization Application (MAA) for ocriplasmin (2.5 mg/ml, solution for injection) for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole. The EMA will evaluate the ocriplasmin MAA through its Centralized Procedure and, if approved, ocriplasmin will gain marketing authorization for all EU Member States simultaneously. Additional information is available at http://thrombogenics.com.

Source: ThromboGenics NV, October 2011.


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