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Volume 13, Number 9
Monday, March 4, 2013
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MARCH IS NATIONAL NUTRITION MONTH




In this issue: (click heading to view article)
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######### Link Between Glaucoma and Vitamins A, C and E Supplement Intake and Serum Levels

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######### Peripheral FAF and Clinical Findings in Neovascular and Non-neovascular AMD
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######### Use of Intravitreal Aflibercept Injection for Macular Edema Secondary to CRVO
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######### Repeated Use of Topical Antibiotic Following Intravitreal Injection and the Antibiotic Resistance of Ocular Surface Flora
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######### Briefly

 

 





Link Between Glaucoma and Vitamins A, C and E Supplement Intake and Serum Levels

To investigate the potential association between glaucoma prevalence and supplemental intake, as well as serum levels of vitamins A, C and E, this cross-sectional study included 2,912 participants in the 2005 to 2006 National Health and Nutrition Examination Survey, age ≥40 years, who self-reported a presence or absence of glaucoma.

Participants were interviewed regarding the use of dietary supplements during the preceding 30-day period and underwent serum measurements of vitamins A, C and E (both alpha- and gamma-tocopherol). Information on the primary outcome measure, presence or absence of glaucoma, as well as demographic information, comorbidities and health-related behaviors, was assessed via interview.

It was reported that multivariate odds ratios for self-reported glaucoma, comparing the highest quartile of consumption to no consumption, and adjusted for potential confounding variables were 0.48 (95% confidence interval (CI) 0.13–1.82) for vitamin A, 0.47 (95% CI 0.23–0.97) for vitamin C and 2.59 (95% CI 0.89–7.56) for vitamin E. It was also noted that adjusted odds ratios for self-reported glaucoma comparing the highest versus the lowest quintiles of vitamin serum levels were 1.44 (95% CI 0.79–2.62) for vitamin A, 0.94 (95% CI 0.42–2.11) for vitamin C, 1.40 (95% CI 0.70–2.81) for alpha-tocopherol and 0.64 (95% CI 0.24–1.70) for gamma-tocopherol.

In conclusion, neither supplementary consumption nor serum levels of vitamins A and E were found to be associated with glaucoma prevalence. While low- and high-dose supplementary consumption of vitamin C was found to be associated with decreased odds of glaucoma, serum levels of vitamin C did not correlate with glaucoma prevalence.

SOURCE: Wang SY, Sing K, Lin SC. Glaucoma and vitamins A, C and E supplement intake and serum levels in a population-based sample of the United States. Eye. 2013; Feb 22. [Epub ahead of print].




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Peripheral FAF and Clinical Findings in Neovascular and Non-neovascular AMD

The authors of the following clinic-based, cross-sectional study sought to characterize peripheral fundus autofluorescence (FAF) abnormalities in patients with age-related macular degeneration (AMD), correlate these with clinical findings, and identify risk factors associated with these FAF abnormalities.

They recruited 119 consecutive patients (100 patients with AMD [200 eyes] and 19 patients without AMD [38 eyes]). In a prospective study performed at the Doheny Eye Institute, University of Southern California, widefield 200-degree FAF and color images were obtained by the Optos 200Tx Ultra-Widefield device using a standardized imaging protocol. According to the authors, the FAF images were captured centered on the fovea, and additional images were captured after steering the field of view inferiorly and superiorly. All FAF and color images were graded independently by two masked ophthalmologists with respect to the presence, location, extent and type of peripheral (defined as outside the central 30 degrees) FAF abnormality. Main outcome measures were presence and type of peripheral FAF abnormalities.

Peripheral FAF abnormalities were evident in 164 eyes (68.9%), with several distinct FAF patterns identified: granular (46.2%), mottled (34.0%) and nummular (18.1%), the authors found. Additionally, they observed a 90% concordance of FAF patterns between both eyes. They also noted that abnormal FAF occurred more frequently in neovascular compared with non-neovascular AMD or normal eyes (86% vs. 72.8% vs. 18.4%, respectively, p<0.001). Significant risk factors for peripheral FAF abnormalities were AMD type (neovascular AMD odds ratio [OR], 12.7 and non-neovascular AMD OR, 6.2 compared with normal eyes, p<0.001), older age (OR, 6.5; 95% confidence interval [CI], 2.4–17.8; p<0.001 for the oldest quartile compared with the youngest), and female sex (OR, 4.1; 95% CI, 1.9–8.9; p<0.001). The study authors detected clinical features on color photography in 174 eyes (73.1%): peripheral drusen (51.7%), retinal pigment epithelium (RPE) depigmentation (34.9%), RPE hyperpigmentation (branching reticular pigmentation) (22.7%) and atrophic patches (16.8%). They also reported a high correlation between specific FAF and clinical findings: granular FAF with peripheral drusen (p<0.001) and mottled FAF with RPE depigmentation (p<0.001).

Several distinct patterns of peripheral FAF abnormalities were observed in 68.9% of patients, with AMD type, female sex and age being independent risk factors. The peripheral FAF patterns correlate strongly with specific clinical features seen in eyes with AMD.

SOURCE: Tan CS, Heussen F, Sadda SR. Peripheral autofluorescence and clinical findings in neovascular and non-neovascular age-related macular degeneration. Ophthalmology. 2013;Feb 25. [Epub ahead of print].



Use of Intravitreal Aflibercept Injection for Macular Edema Secondary to CRVO

Researchers conducted this randomized controlled trial to evaluate intravitreal aflibercept injections (IAI; also called VEGF Trap-Eye) for patients with macular edema secondary to central retinal vein occlusion (CRVO). They found that monthly injections of 2 mg intravitreal aflibercept for patients with macular edema secondary to CRVO resulted in a statistically significant improvement in visual acuity at week 24, which was largely maintained through week 52 with intravitreal aflibercept p.r.n. dosing.

In this multicenter study, 189 patients (one eye/patient) with macular edema secondary to CRVO were randomized to receive six monthly injections of either 2 mg intravitreal aflibercept (IAI 2Q4) (n=115) or sham (n=74). The study researchers reported that from week 24 to week 52, all patients received 2 mg intravitreal aflibercept as needed (IAI 2Q4 + p.r.n. and sham + IAI p.r.n.) according to retreatment criteria. The primary endpoint was the proportion of patients who gained ≥15 ETDRS letters from baseline at week 24. Additional endpoints included visual, anatomic and quality-of-life NEI VFQ-25 outcomes at weeks 24 and 52.

At week 24, the researchers noted that 56.1% of IAI 2Q4 patients gained ≥15 letters from baseline compared with 12.3% of sham patients (p<.001). They noted that at week 52, 55.3% of IAI 2Q4 + p.r.n. patients gained ≥15 letters compared with 30.1% of sham + IAI p.r.n. patients (p<.001). At week 52, IAI 2Q4 + p.r.n. patients gained a mean of 16.2 letters of vision versus 3.8 letters for sham + IAI p.r.n. (p<.001). Intravitreal aflibercept injection was generally well-tolerated. The most common adverse events for both groups were conjunctival hemorrhage, eye pain, reduced visual acuity and increased intraocular pressure.

SOURCE: Brown DM, Heier JS, Clark WL, et al. Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the Phase III COPERNICUS study. Am J Ophthalmol. 2013;155(3):429–437.






Repeated Use of Topical Antibiotic Following Intravitreal Injection and the Antibiotic Resistance of Ocular Surface Flora

Treatment with intravitreal (IVT) injections has increased during the last several years as evidence has accumulated demonstrating the efficacy of anti–vascular endothelial growth factor agents in the treatment of neovascular age-related macular degeneration (AMD) and various retinal vascular diseases. Although IVT injections are generally safe, infectious endophthalmitis is a rare but devastating complication, and the risk of morbidity and vision loss is high. In the following prospective, nonrandomized cohort study in two tertiary academic hospitals, investigators examined the change of antibiotic resistance of ocular surface flora with repeated prophylactic use of antibiotics after IVT injection for AMD.

Seven retinal specialists recruited patients 65 years and older with newly diagnosed AMD from July 1, 2010 through December 31, 2011. The study group received topical moxifloxacin hydrochloride for three days after each monthly IVT injection. As far as main outcome measure, resistance to moxifloxacin and ceftazidime in cultured isolates at baseline and monthly for three months by change in minimal inhibitory concentration (MIC) of culture isolates was studied.

According to the investigators, the study group consisted of 84 patients; the control group had 94 patients. In the study group, the baseline-adjusted MIC increased (from 1.04 to 1.25 µg/mL; p=.01) as did the MIC for 50% of isolates (MIC50) (from 0.64 to 1.00 µg/mL) and the MIC for 90% of isolates (MIC90) (from 0.94 to 4.00 µg/mL). They noted that in both groups, the culture-positive rate did not change significantly when adjusted for baseline. Additionally, they found no significant change in the MIC level, culture-positive rate, MIC50 level and MIC90 level in the control group. Furthermore, subgroup analysis found diabetes mellitus to be noncontributory to both the MIC and culture-positive rate. No endophthalmitis or adverse events were reported.

To conclude, repeated use of topical moxifloxacin after IVT injection significantly increases antibiotic resistance of ocular surface flora. The study investigators recommend that routine use of prophylactic antibiotics after IVT injection be discouraged.

SOURCE: Yin VT, Weisbrod DJ, Eng KT, et al. Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA Ophthlamol. 2013;Feb 21. [Epub ahead of print].





  • ALLEGRO COMPLETES ENROLLMENT FOR AMD STUDY AND BEGINS STUDY FOR DME. Allegro Ophthalmics LLC has completed enrollment of its Phase Ib/IIa study in wet age-related macular degeneration (AMD) in addition to commencing its second diabetic macular edema (DME) study. The DME study is masked and will observe the additional clinical benefit of therapy with ALG-1001 (Integrin Peptide Therapy) in combination with bevacizumab (Avastin) versus bevacizumab alone in patients with baseline DME that has not been resolved by repeated intravitreal anti-VEGF treatments. A total of 30 subjects will be divided into three groups; two of which will receive four monthly intravitreal injections of Avastin plus ALG-1001 (at two different doses of ALG-1001). The third group will receive four monthly intravitreal injections of Avastin and a sham injection. After the four monthly injections, the subjects will be observed for 30 days off-treatment for a total of 120 days of observation. The wet AMD study, on the other hand, is a dose-ranging, monotherapy study with a primary endpoint of safety and a secondary endpoint of improvement in both best-corrected visual acuity (BCVA) and OCT central macular thickness (CMT). Learn more about Allegro Ophthalmics and Integrin Peptide Therapy by visiting www.allegroeye.com.
  • ACIEX AND PORTOLA ENTER COLLABORATIVE RESEARCH AGREEMENT. Aciex Therapeutics Inc. and Portola Pharmaceuticals Inc. have entered into a collaborative research agreement that provides Aciex with exclusive rights to develop Portola's small molecule dual Spleen Tyrosine Kinase (Syk)/Janus Kinase (JAK) inhibitors for ophthalmic indications. The companies will target development of drugs to treat topical ophthalmic diseases including ocular allergy, dry eye and other inflammatory eye conditions for which there is a strong scientific rationale for Syk and JAK inhibition. Under the terms of the agreement, Aciex will obtain access to Portola’s small molecule dual Syk/JAK inhibitors and will lead clinical development activities for ophthalmic indications. Both companies will fund and participate in development activities related to the programs and Portola will retain the right to develop these compounds for non-ophthalmic indications.
  • OCULAR THERAPEUTIX SUBMITS PMA APPLICATION FOR RESURE SEALANT. Ocular Therapeutix Inc. recently submitted its Premarket Approval (PMA) Application to the FDA for ReSure Sealant, a novel ophthalmic medical device that utilizes the company's proprietary hydrogel technology. The proposed indication for ReSure Sealant is intraoperative management of clear corneal incisions with a wound leak as demonstrated by a Seidel test, and for prevention of postoperative fluid egress following cataract or intraocular lens placement surgery. ReSure Sealant was evaluated in a prospective, randomized, parallel arm, controlled, subject-masked U.S. Pivotal Clinical Trial in which 488 subjects were enrolled at 24 sites throughout the United States. The study compared the ReSure hydrogel sealant with sutures for safety and effectiveness within the first seven days following cataract surgery. Pending FDA approval, ReSure Sealant would be the first and only sealant approved for ophthalmic use. Click here to read more about ReSure Sealant.
  • OPTIMEDICA GRANTED FUNDAMENTAL PATENT ON LASER CATARACT SURGERY. The U.S. Patent & Trademark Office granted OptiMedica Corp. a patent relating to the fundamental technology underlying laser cataract surgery. The patent, which will issue on March 12, 2013 at U.S. patent no. 8394084, contains broad claims and describes a 3D image-based femtosecond laser system for performing anterior capsulotomy and lens fragmentation during the cataract procedure. According to OptiMedica, Catalys has been shown in numerous clinical studies to perform the laser cataract procedure with precision and accuracy that is unparalleled in the industry. Additionally, laser lens fragmentation with Catalys has been shown to dramatically reduce or eliminate the need for ultrasound energy to break up and remove the cataract. Additional details can be found at www.optimedica.com.
  • LUMENIS AND THE WILLS EYE INSTITUTE JOIN TO ADVANCE GLAUCOMA RESEARCH AND EXPAND CARE IN PHILADELPHIA. Lumenis Ltd. has announced a collaboration with the Wills Eye Institute, Glaucoma Research Center, in Philadelphia to provide access to glaucoma treatment using the Selecta Duet SLT Laser system to Philadelphia's underserved populations. The Wills Eye Institute will bring the gold standard in glaucoma laser care to patients around the city to improve eye care for individuals who suffer from this debilitating condition via a mobile unit and will collect epidemiological data with the goal of analyzing the impact of early treatment on disease progression. For additional information, visit www.lumenis.com.
  • VISTAKON ANNOUNCES THREE ACUVUE BRAND DISCONTINUATIONS IN 2013. VISTAKON Division of Johnson & Johnson Vision Care Inc. will be discontinuing three of its older brands this year. ACUVUE Brand Contact Lenses will no longer be available in select base curves and parameters in the United States as of July 1, 2013. All 9.1 base curves and 8.4 and 8.8 base curves of parameters from –6.50 to –11.0 are being discontinued. The company notes that products with 8.4 and 8.8 base curves and parameters ranging from –0.50 to –6.00 will continue to be available but that all parameters of ACUVUE Brand Contact Lenses BIFOCAL and ACUVUE 2 COLOURS Brand Contact Lenses will be discontinued as of December 31, 2013.
  • NEW COOPERVISION WEBSITE BENEFITS U.S. MILITARY PERONNEL. CooperVision Inc. launched a new website in partnership with the Armed Forces Optometric Society (AFOS), reinforcing the company's continued commitment to serving the U.S. military community. By visiting www.coopervision.com/armedforces, military members and their families can purchase CooperVision's contact lenses affordably and be assured guaranteed delivery wherever they are located around the world. Additionally, for every box of CooperVision Biofinity, Avaira and Proclear 1 day contact lenses purchased through the website, CooperVision will donate $1 to the Wounded Warrior Project.
  • TEARSCIENCE SECURES FUNDING FROM HEALTHCARE ROYALTY PARTNERS. TearScience Inc. reported that it has secured up to $70 million in funding from HealthCare Royalty Partners to fully implement the company's commercialization efforts and establish the TearScience system as the “standard of care” for evaporative dry eye. The system includes the LipiView Ocular Surface Interferometer and the LipiFlow Thermal Pulsation System. Read more here.




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