Volume 12, Number 8
Monday, February 20, 2012


In this issue: (click heading to view article)
######### Changes in Microperimetry Following Intravitreal Bevacizumab Injection for Exudative AMD

######### Higher Antioxidant Intakes in the Prevention of AMD
######### Relationship Between Obesity and MPOD
######### Influence of Cataract on RNFL Measurements by TD-OCT and SD-OCT
######### Briefly




Changes in Microperimetry Following Intravitreal Bevacizumab Injection for Exudative AMD

Researchers in Turkey evaluated the effect of intravitreal bevacizumab on macular function in the cases of exudative age-related macular degeneration (AMD). They found that intravitreal bevacizumab therapy induced a significant increase in mean retinal sensitivity and significant decrease in mean absolute scotoma size during 6 months. They also determined that the MP-1 microperimetry proved to be a valuable tool in the evaluation of functional benefit of exudative AMD therapy with intravitreal bevacizumab.

In this study, they included 21 eyes of 21 patients with exudative AMD and in each eye, at baseline and 1, 3 and 6 months after intravitreal bevacizumab injection, they assessed logMAR visual acuity, central 4° macular sensitivity, absolute scotoma size, fixation stability and fixation location by MP-1 microperimetry and optical coherence tomography (OCT) foveal morphologic changes. Following the initial treatment phase, which included three consecutive injections, they based their decision to re-treat on OCT and clinical findings. Subsequent injections could be administered at least 1 month after the previous injection period according to the OCT-guided treatment regimen.

The researchers in this study found that mean retinal sensitivity within central 4° (12 points) area had increased from 3.69 ± 3.44 dB at baseline to 7.16 ± 3.27 dB at month 6. In all controls after the treatment, they reported a significant increase in logMAR visual acuity (p<0.001) and MP-1 retinal sensitivity (p<0.001). Mean absolute scotoma in test point location had decreased significantly from 12 of the 76 applied test point locations measured at baseline to five test point locations (–7 test point locations; p<0.001) at month 6 showing statistical significance. Fixation properties had preserved in all patients 6 months after intravitreal bevacizumab treatment.

SOURCE: Ozdemir H, Karacorlu M, Senturk F, et al. Microperimetric changes after intravitreal bevacizumab injection for exudative age-related macular degeneration. Acta Ophthalmol. 2012;90(1):71–75.

Higher Antioxidant Intakes in the Prevention of AMD

The following multicenter, prospective open-label, randomized study sought to determine whether nutritional supplementation with a targeted nutritional supplement improves visual acuity and function in age-related macular degeneration (AMD).

In it, 145 patients were randomly assigned to 2 different treatment groups. Interventions were lutein (10 mg), zeaxanthin (1 mg), astaxanthin (4 mg; AZYR SIFI, Catania, Italy) and antioxidants/vitamins supplementation formula or no dietary supplementation for 2 years. Primary outcome was mean changes in visual acuity (VA) at 12 and 24 months; other measures included contrast sensitivity (CS) and National Eye Institute visual function questionnaire (NEI VFQ-25) scores at 12 and 24 months.

Patients in the treated group showed stabilization of VA with significantly (p=0.003) better VA scores (81.4 ± 7.2) compared to the nontreated group (76.8 ± 8.9) at 24-month follow-up. Furthermore, an improvement in CS (p=0.001) and final mean NEI VFQ=25 composite scores at 12 and 24 months higher in treated group compared to non-treated group were also shown (p<0.001).

In conclusion, patients treated with lutein/zeaxanthin and astaxanthin together with other nutrients were more likely to report clinically meaningful stabilization/improvements in VA, CS and visual function through 24 months compared with nontreated subjects. Further studies are needed with more patients and for longer periods of time.

SOURCE: Piermarocchi S, Saviano S, Parisi V, et al; for The Carmis Study Group. Carotenoids in Age-Related Maculopathy Italian Study (CARMIS): two-year results of a randomized study. Eur J Ophthalmol. 2012;22(2):216–225.

Relationship Between Obesity and MPOD

To elucidate the association between macular pigment optical density (MPOD) and various types of obesity in the South-Indian population, investigators studied 300 eyes of 161 healthy volunteers of South-Indian origin.

They measured MPOD psychophysically at 0.25°, 0.50°, 1.00° and 1.75 eccentricities from fovea. Anthropometric measurements included waist circumference (WC) and waist-to-hip ratio (WHR) as well as body mass index (BMI). Using the World Health Organization Expert Consultation guidelines, the investigators defined obesity based on BMI alone (BMI ≥ 23 kg/m²), WC alone (WC ≥ 90 cm for men and ≥ 80 cm for women) and on WHR alone (≥ 0.90 for men and ≥ 0.85 for women). They defined isolated generalized obesity as increased BMI and normal WC and isolated abdominal obesity as increased WC and normal BMI. They defined combined obesity as increased BMI and increased WC.

Mean MPOD at all eccentricities was not significantly different between men and women, the investigators observed. They also noted that mean MPOD values did not significantly differ in various types of obesity, when compared with the normal subjects. On subgroup analysis, in age group ≥60 years, mean MPOD values were significantly higher in subjects with obesity based on BMI (0.61 vs 0.41, p=0.036), obesity based on WHR (0.67 vs 0.41, p=0.007) and isolated generalized obesity (0.66 vs 0.41, p=0.045) in comparison with normal subjects at 0.25° eccentricity.

The investigators reported finding lack of an association between MPOD and obesity in the South-Indian population. They noted a similar finding on age group- and gender-wise analyses.

SOURCE: Gupta A, Raman R, Biswas S, et al. Association between various types of obesity and macular pigment optical density. Eye. 2012;26(2):259–266.



Influence of Cataract on RNFL Measurements by TD-OCT and SD-OCT

The authors of this study assessed and compared the influence of cataract on measurements of retinal nerve fiber layer (RNFL) thickness by time domain optical coherence tomography (TD-OCT) and spectral domain OCT (SD-OCT). They found that the presence of cataract significantly affects RNFL thickness measurements by SD-OCT and TD-OCT.

They consecutively enrolled patients who underwent uncomplicated cataract surgery in this study and measured the peripapillary RNFL thickness before and 8 weeks after cataract surgery using TD-OCT and SD-OCT during the same visit. Additionally, they evaluated changes in the RNFL thickness measurement and signal strength (SS) following cataract surgery.

The authors included a total of 54 patients (54 eyes) and after excluding 19 of these eyes owing to poor imaging or low SS (<5), they included scans of 35 eyes in the final analysis. They identified a significant difference between the preoperative and postoperative SS values using SD-OCT, but not TD-OCT (p=0.002 and 0.789, respectively). They reported that the changes in RNFL thickness after cataract surgery were more prominent and frequent for SD-OCT than for TD-OCT. There was a significant correlation between change in preoperative RNFL thickness and SS changes for both TD-OCT (r²=0.410, p<0.001) and SD-OCT (r²=0.246, p=0.002).

To conclude, SD-OCT, which demonstrated more consistent change of RNFL measurements after cataract extraction, is not necessarily associated with lower RNFL thickness measurement performance in cataract cases, as more participants with cataract were excluded because of poor image quality or low SS, which was more associated with TD-OCT than SD-OCT.

SOURCE: Kim NR, Lee H, Lee ES, et al. Influence of cataract on time domain and spectral domain optical coherence tomography retinal nerve fiber layer measurements. J Glauc. 2012;21(2):116–122.


  • MOBIUS RECEIVES FINAL APPROVAL FOR MITOSOL FROM FDA. Mobius Therapeutics, LLC can now start marketing and production efforts for the platform product Mitosol, now that it has received final approval for the drug from the FDA. This initial indication is for the use of Mitosol in glaucoma surgery. According to the company, Mitosol provides a new system for delivering a precise dose of its active ingredient, mitomycin-c, to ophthalmic surgeons for use in procedures without any change to their current technique. Click here to learn more.
  • FIRST PATIENT DOSED IN PHASE 2a CLINICAL TRIAL OF ATS907 FOR THE REDUCTION OF IOP. Altheos, Inc. has announced the dosing of the first patient in a Phase 2a clinical trial of its lead investigational candidate, ATS907, a Rho kinase (ROCK)-selective inhibitor in development as a next-generation eye drop for the reduction of elevated IOP in primary open-angle glaucoma and ocular hypertension. The study uses a two-stage adaptive design and is intended to evaluate a number of different doses of ATS907 ophthalmic formulation and to provide preliminary information on safety, tolerability and efficacy (reduction in intraocular pressure) following 28 days of administration. ATS907 is one of a series of ROCK inhibitor compounds licensed from Asahi Kasei Pharma. In other company news, Altheos has raised an additional $12.5M in its Series A financing, bringing the total to $32.5M, which will enable completion of a robust Phase 2 clinical program. For additional information, click here.
  • HEIDELBERG UNVEILS NEW IMAGING MODALITY. Heidelberg Engineering is launching MultiColor Scanning Laser Imaging as a new dimension in multi-modality fundus imaging with the Spectralis product family. The company says that MultiColor imaging uses multiple laser colors simultaneously to selectively capture and display diagnostic information originating from different retinal structures within a single examination. Spectralis with MultiColor will initially be available in Europe and is expected to be available in the United States and other countries later this year. Get more information at www.heidelbergengineering.com.
  • NEW PORTABLE OPTHALMIC CAMERA AVAILABLE FROM EYEQUICK. The EyeQuick Digital Ophthalmoscope Camera, recently cleared by the FDA, captures photographs and videos with the press of a button. EyeQuick, LLC says its new portable ophthalmic retinal and anterior segment camera gives clinicians an affordable means to document pathology in any setting and on patients of any age or physical capability. Images are instantly viewable on the built-in LCD screen and at any time can be exported via the EyeQuick's USB port. Distributed by EyeQuick and manufactured by Miller Technical Services, the EyeQuick Digital Ophthalmoscope Camera comes with a rechargeable battery and a sturdy metal carrying case, and at 13 ounces and 9 inches, weighs about as much as a full can of soda and stands about as high as two stacked soda cans. Learn more at www.EyeQuick.com.
  • FDA APPROVES ZIOPTAN FOR REDUCING IOP. According to a Santen Pharmaceutical Co., Ltd. press release, Merck & Co., Inc. received the approval of Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution from the U.S. FDA. The approval was based on efficacy and safety results from five controlled clinical studies of up to two years in 905 patients. Both preservative-containing and preservative-free formulations of tafluprost were used in these clinical studies. Zioptan, approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was shown to have powerful IOP-lowering effects in clinical studies. In April 2009, Merck and Santen entered into a worldwide licensing agreement for tafluprost that defined commercial rights between the two companies with regard to tafluprost in various territories. Merck anticipates that Zioptan will be available to customers in the United States in March.
  • EYETECH ACQUISITION ANNOUNCED. In a recent press release, Valeant Pharmaceuticals International, Inc. announced that it has agreed to acquire ophthalmic biotechnology company Eyetech Inc. for an upfront payment and potential future milestones that total significantly less than two times sales. Eyetech currently markets the anti-VEGF inhibitor Macugen, approved for the treatment of wet AMD, in the United States.
  • COUNTERFEIT AVASTIN FOUND. The FDA has issued a statement warning about a counterfeit version of the injectable cancer drug Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version of the drug does not contain the active ingredient bevacizumab, which may have resulted in patients not receiving needed therapy. The FDA sent letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin. Packages or vials may be counterfeit if they are labeled with Roche as the manufacturer and/or display batch numbers that start with B6010, B6011 or B86017. Learn more at the FDA's website. The agency will continue to evaluate this situation and will provide updates. See Roche's statement about this counterfeit medicine.
  • SD-OCT USED FOR FIRST TIME IN ELEPHANT CATARACT SURGERY. In November 2011, a team of specialists from the North Carolina State University College of Veterinary Medicine, led by Dr. Richard J. McMullen Jr., assistant professor of ophthalmology, performed cataract surgery on the North Carolina Zoo's longest resident, a 38-year-old African elephant named C'sar. The four-hour procedure, which used Bioptigen's Envisu R2300 ophthalmic imaging system, was the fifth cataract surgery performed on an elephant anywhere in the world. It also marked the first time a spectral-domain optical coherence tomography imaging system was used on an elephant.

    After suffering from deteriorating vision in both eyes caused by cataracts since 2010, C'sar was taken out of exhibit and has been sheltered within his barn and paddock since March 2011. Because of damaged tissue caused by the cataract, C'sar's eye would not have provided enough support for the specially created artificial lens Dr. McMullen had intended to implant. However, removal of the cataract does leave him with improved, though farsighted, vision. The zoo staff looks forward to allowing the pachyderm to return to his exhibit once the weather and his recovery allows it, but if he has problems safely negotiating the space, the keepers and veterinary staff will discuss the possibility of operating on his other eye with the hope of further improving his vision. Read more about C'sar's story here.

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