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Volume 12, Number 14
Monday, April 2, 2012
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In this issue: (click heading to view article)
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######### Effect of Carotenoids in AMD

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######### A Closer Look at the Hyporeflective Wedge-Shaped Band in GA Secondary to AMD
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######### Treatment of Polypoidal Choroidal Vasculopathy with Combined Intravitreal Ranibizumab and PDT
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######### RNFL Thickness and Abnormalities of Vision in People with HIV Infection
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Effect of Carotenoids in AMD

The high concentration of carotenoids in the macula, combined with evidence linking oxidative stress to age-related macular degeneration (AMD) and carotenoids to antioxidation, generated the hypothesis that higher antioxidant intakes can prevent AMD. The authors of the following multicenter, prospective, open-label, randomized study randomly assigned 145 patients to 2 different treatment groups to determine whether nutritional supplementation with a targeted nutritional supplement improves visual acuity and visual function in AMD.

Interventions were lutein (10 mg), zeaxanthin (1 mg), astaxanthin (4 mg), 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.

The study authors reported that 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. They also observed 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 nontreated group (p<0.001).

They concluded that 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.




http://corporate.eyemaginations.com/healthcare-solutions/eyecare/luma/pricing







A Closer Look at the Hyporeflective Wedge-Shaped Band in GA Secondary to AMD

To report the incidence of glaucoma and glaucoma suspects in the Infant Aphakia Treatment Study (IATS), and to evaluate risk factors for the development of a glaucoma-related adverse event in patients in the IATS in the first year of follow-up, the authors of this study assigned 114 infants between 1 and 6 months of age with a unilateral congenital cataract to undergo cataract surgery either with or without an intraocular lens implant.

They created standardized definitions of glaucoma and glaucoma suspect, which they used in the IATS. According to the authors, of the 114 patients, 10 (9%) developed glaucoma and 4 (4%) had glaucoma suspect, for a total of 14 patients (12%) with a glaucoma-related adverse event in the treated eye through the first year of follow-up. They also observed that of the 57 patients who underwent lensectomy and anterior vitrectomy, 5 (9%) developed a glaucoma-related adverse event; of the 57 patients who underwent an intraocular lens implant, 9 (16%) developed a glaucoma-related adverse event. The odds of developing a glaucoma-related adverse event were 3.1 times higher for a child with persistent fetal vasculature and 1.6 times higher for each month of age younger at cataract surgery.

In conclusion, modern surgical techniques do not eliminate the early development of glaucoma following congenital cataract surgery with or without an intraocular lens implant. Younger patients with or without persistent fetal vasculature seem more likely to develop a glaucoma-related adverse event in the first year of follow-up. Vigilance for the early development of glaucoma is needed following congenital cataract surgery, especially when surgery is performed during early infancy or for a child with persistent fetal vasculature. Five-year follow-up data for the IATS will likely reveal more glaucoma-related adverse events.

SOURCE: Monés J, Biarnés M, Trindade F. Hyporeflective wedge-shaped band in geographic atrophy secondary to age-related macular degeneration: an underreported finding. Ophthalmol. 2012;March 22 [Epub ahead of print]. DOI: 10.1016/j.ophtha.2012.01.026.








Treatment of Polypoidal Choroidal Vasculopathy with Combined Intravitreal Ranibizumab and PDT

To clarify the efficacy of combined therapy with intravitreal ranibizumab injections and photodynamic therapy (PDT) in patients with symptomatic polypoidal choroidal vasculopathy, 28 naive eyes of 28 patients (17 men, 11 women; mean age, 73.4 years; range, 55–85 years) with 20/40 or less baseline visual acuity treated with 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg/0.05 mL) and photodynamic therapy and followed-up for at least 12 months were retrospectively reviewed. PDT was administered 1 or 2 days after the initial injection of ranibizumab.

The mean best-corrected visual acuity (BCVA) levels significantly (p< 0.0001) improved from 0.33 at baseline to 0.61 at 12 months and the mean improvement in BCVA 12 months from baseline was 2.65 lines. The BCVA at 12 months improved in 15 eyes (53.6%) by ≥ 3 lines and was stable (defined as a loss of <3 lines of vision) in 13 eyes (46.4%). The central retinal thickness significantly (p<0.0001) decreased from 366 µm to 151 µm at 12 months. The mean numbers of PDT treatments and injections during 12 months including the treatments during the initial regimen were 1.1 and 3.7, respectively. It was noted that no complications developed.

To conclude, combined intravitreal ranibizumab and PDT for polypoidal choroidal vasculopathy maintained or improved visual acuity and reduced the exudation without adverse events.

SOURCE: Saito M, Iida T, Kano M. Combined intravitreal ranibizumab and photodynamic therapy for polypoidal choroidal vasculopathy. Retina. 2012;March 23 [Epub ahead of print]. DOI: 10.1097/IAE.0b013e318236e624.

 



http://ecatalog.alcon.com/PI/Nevanac_us_en.pdf






RNFL Thickness and Abnormalities of Vision in People with HIV Infection

U.S. investigators examined relationships between contrast sensitivity (CS), color vision and retinal nerve fiber layer (RNFL) among people with human immunodeficiency virus (HIV) infection and evaluated the effect of time since diagnosis of HIV infection on RNFL thickness.

In this noninterventional cross-sectional study, they evaluated 102 eyes of 57 HIV-infected individuals without ocular opportunistic infections. They determined peripapillary RNFL thickness with spectral-domain optical coherence tomography (SD-OCT) in 4 quadrants and measured CS with the Pelli-Robson technique (expressed as logCS). Additionally, they measured color vision with the Lanthony desaturated 15-hue technique (expressed as color confusion index [C-index], with higher scores indicating worse color vision) and assessed correlations between values using Spearman correlation coefficients.

According to the investigators, median RNFL thickness (average of 4 quadrants) was 102.9 µm (range, 75.0–134.7 µm) and median logCS was 1.90 (range, 1.250–1.95). The study investigators also reported that median C-index was 1.58 (range, 0.960–4.07) and that temporal RNFL thickness was correlated with logCS (r = 0.295, p = .003) and C-index (r = 0–0.338, p = .0005). Furthermore, time since diagnosis of HIV infection was shorter for those with thick average RNFL than for those with thin average RNFL (p = .18).

The investigators determined that both worse CS and worse color vision are correlated with thinning of the temporal RNFL, with possible threshold effects. Increased prevalences of abnormal CS and abnormal color vision in this population are therefore likely attributable to neuroretinal compromise. This pattern of structural and functional losses may reflect preferential damage to small-caliber axons in the maculopapillary bundle, possibly associated with mitochondrial dysfunction, providing a potential disease mechanism for HIV-associated “neuroretinal disorder.”

SOURCE: Kalyani PS, Holland GN, Fawzi AA, et al; Studies of the Ocular Complications of AIDS Research Group. Association between retinal nerve fiber layer thickness and abnormalities of vision in people with Human Immunodeficiency Virus infection. Am J Ophthalmol. 2012;153(4):734–742.











 




  • BAUSCH + LOMB ANNOUNCES ACQUISITION OF ISTA PHARMACEUTICALS. Bausch + Lomb and ISTA Pharmaceuticals, Inc. have signed a definitive agreement under which Bausch + Lomb will acquire ISTA for $9.10 per share in case, or a total of approximately $500 million. The boards of directors of both companies unanimously approved the transaction, which is expected to close in the second quarter of 2012 and to be accretive to Bausch + Lomb's EBITDA in the first year after close. The transaction is subject to regulatory approval and other customary closing conditions, including the approval of ISTA'S shareholders, and is expected to drive growth and high performance for the long term. According to a Bausch + Lomb press release, the company's acquisition of ISTA accelerates its strategy to strengthen its pipeline and marketed products and capabilities. Both companies will continue to operate independently until completion of the transaction.
  • ISTA REACHES SETTLEMENT ON ROYALTY DISPUTE. ISTA Pharmaceuticals, Inc. has settled all issues with Senju Pharmaceutical Co., Ltd. that had been in arbitration before the International Chamber of Commerce (ICC) and has come to an agreement with the company on disputed royalty payments for Xibrom and Bromday (bromfenac ophthalmic solution) 0.09% eye drops, approved for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extractions. The dispute concerned the amount of royalties owed after the patent covering Xibrom and Bromday expired in 2009. According to ISTA, the settlement established separate royalty rates for Bromday and its potential new proprietary product, Prolensa, also for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extractions, maintaining the existing rate for Prolensa. The two companies will continue their relationship under the terms of an exclusive license agreement covering the products through expiration of the last licensed patent, currently anticipated to be September 2025. Click here for more information.
  • iCO THERAPEUTICS AND JDRF SUPPORT PHASE II CLINICAL TRIAL FOR DME TREATMENT. iCo Therapeutics and charitable funder JDRF have joined forces to investigate a potential new treatment for diabetic macular edema (DME). The iDEAL study is a Phase II clinical trial to evaluate whether the drug iCo-007 could help to treat DME in people with either type 1 or type 2 diabetes. It explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in people with DME. The iDEAL study, which is in the process of recruiting participants, follows patients for a 12-month period, during which, patients are randomized into one of the following four groups: either one of two mono-therapy arms using repeated intravitreal dosing of two different concentrations of iCo-007; or one of two combination arms using iCo-007 with laser photocoagulation or iCo-007 and ranibizumab. To be eligible for the trial, participants must have type 1 or type 2 diabetes, baseline visual acuity between 20/32 and 20/320 on the Early Treatment Diabetic Retinopathy Study ETDRS chart, and DME with central subfoveal thickness > 250 µm on OCT. Read more here.
  • US PATENT AND TRADEMARK OFFICE ALLOWS ADDITIONAL PATENT FOR OMEROS'S OMS302. In a recent press release, Omeros Corporation reported the allowance by the U.S. Patent and Trademark Office of an additional patent claiming intraocular surgical methods of using OMS302, the company's ophthalmological PharmacoSurgery product currently in Phase 3 clinical development. The issued patent will have a term extending through July 2023 and extends coverage for OMS302, which is designed to maintain intraoperative mydriasis (pupil dilation) and reduce pain in the early postoperative period in patients undergoing intraocular lens replacement surgery, including cataract and refractive lens exchange.
  • OPTOS DELIVERS FIRST SHIPMENTS OF DAYTONA RETINAL IMAGING DEVICES. Optos plc has delivered the first Daytona devices to customers in line with expectations. The company says the Daytona represents the next generation of Optos ultra-widefield retinal imaging technology and has been scaled to accommodate smaller office spaces while providing high-resolution imaging and adding new auto-fluorescence capabilities. Daytona's new ergonomic body weighs only about 25 kg and is designed to increase patient comfort, as well as make it easier to correctly position the eye. It also features an improved user interface with intuitive, workflow-based software. For additional information, click here.




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