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Volume 14, Number 6
Monday, February 10, 2014
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FEBRUARY IS AMD/LOW VISION AWARENESS MONTH




In this issue: (click heading to view article)
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######### Imaging of Sub-RPE Linear Structures in AMD Patients
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######### Risk Factors Liked to Reticular Pseudodrusen vs. Large Soft Drusen
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######### Affect of Lifitegrast Ophthalmic Solution 5.0% on Dry–Eye Disease
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######### Potential Association Between Postmenopausal Hormone Use and POAG
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Imaging of Sub-RPE Linear Structures in AMD Patients

The authors of this retrospective observational case study evaluated hyper-reflective linear structures (HLS) as assessed using spectral-domain optical coherence tomography (SD-OCT), identified under the retinal pigment epithelium (RPE) in patients with age-related macular degeneration (AMD).

The study involved 427 eyes of 408 consecutive patients who were scheduled to undergo anti-vascular endothelial growth factor (anti-VEGF) therapy for AMD. Patients with HLS under the RPE were investigated based on the SD-OCT findings at baseline or during the follow-up period. The authors also investigated the associations between HLS and the lesion subtypes, localization in SD-OCT, clinical findings, and structural change after anti-VEGF treatment.

They identified HLS in 18 eyes of 16 patients. From the eyes with HLS, they diagnosed 12 eyes (66.7%) with retinal angiomatous proliferation (RAP), four eyes (22.2%) with occult choroidal neovascularization, and the remaining two eyes (11.1%) with polypoidal choroidal vasculopathy. HLS were multifocal and exhibited multi-localization under the RPE in all the eyes. And although it was difficult to identify these structures in the clinical findings at baseline, the authors observed crystalline deposits that correlated with the linear bands during the follow-up period in 16 eyes (88.9%). After the anti-VEGF treatments, the HLS remained between Bruch’s membrane and the RPE or combined with the fibrovascular component.

HLS are rare SD-OCT findings found in patients with AMD, found in only 4.2% of the patients examined in this study. HLS were found especially in RAP lesions.

SOURCE: Inoue M, Arakawa A, Yamane S, Kadonosono K. Imaging of sub-retinal pigment epithelial linear structures in patients with age-related macular degeneration. Eur J Ophthalmol. 2014; Jan 27. [Epub ahead of print].



Risk Factors Liked to Reticular Pseudodrusen vs. Large Soft Drusen

In the following prospective case-case comparison, researchers investigated genetic, environmental and systemic risk factors in prospectively identified subjects with the age-related macular degeneration (AMD) phenotypes of (a) reticular pseudodrusen without large soft drusen and (b) large soft drusen without reticular pseudodrusen.

In a clinical practice setting, the researchers sequentially screened patients with AMD using clinical examination and scanning laser ophthalmoscopy imaging to prospectively identify subjects (n=73) with the phenotypes of (a) reticular pseudodrusen without large soft drusen (n=30) or (b) large soft drusen without reticular pseudodrusen (n=43). They genotyped subjects for two alleles associated with AMD, age-related maculopathy susceptibility 2 (ARMS2) and complement factor H (CFH). Finally, they administered a questionnaire to collect history of smoking, hypertension, diabetes and hyperlipidemia, as well as personal and family history of AMD.

The study researchers found that the reticular pseudodrusen group was older (median age 87 vs. 81 years, p=0.04) and had more females (83.3% vs. 48.8%, p=0.003), later ages of AMD onset (83 vs. 70 years, p=0.0005), and a greater frequency of hypertension (76.7% vs. 55.8%, p=0.08). They found no significant differences in the distribution of the ARMS2 risk allele (p=0.4) between the reticular pseudodrusen (homozygous=20.0%; heterozygous=56.7%) and large soft drusen (homozygous=19.0%; heterozygous=42.9%) phenotypes, or in the distribution of the CHF risk allele (p=0.7) between the reticular pseudodrusen (homozygous=26.7%; heterozygous=56.7%) and large soft drusen (homozygous=21.4%; heterozygous=66.7%) phenotypes.

In conclusion, the researchers associated the reticular pseudodrusen phenotype with increased age, later age of AMD onset and female gender.

SOURCE: Boddu S, Lee MD, Marsiglia M, et al. Risk factors associated with reticular pseudodrusen versus large soft drusen. Am J Ophthalmol. 2014; Feb 3. [Epub ahead of print].


Affect of Lifitegrast Ophthalmic Solution 5.0% on Dry–Eye Disease

To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0% compared with placebo in subjects with dry-eye disease, investigators conducted this prospective, randomized, double-masked, placebo-controlled, parallel arm, multicenter clinical trial.

Included were 588 adult subjects with dry eye disease. The investigators randomized eligible subjects 1:1 to receive topically administered lifitegrast (5.0%) or placebo (vehicle) twice daily for 84 days after a 14-day open-label placebo run-in period. Following enrollment (day zero), they evaluated subjects at days 14, 42 and 84 and they assessed key objective (fluorescein and lissamine staining scores [Ora scales]) and subjective (Ocular Surface Disease Index [OSDI], seven-tem visual analog scale, and ocular discomfort score [Ora scale]) measures at all visits. The primary objective efficacy measure (sign) was mean change from baseline inferior corneal staining score (ICSS) at day 84. The co-primary subjective efficacy measure (symptom) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index (VR-OSDI). Supportive measures included corneal fluorescein scores (superior, central, total region) and conjunctival lissamine scores (nasal, temporal, total region) and symptom scores at day 84.

According to the investigators, the study met the primary objective efficacy ICSS endpoint in demonstrating superiority of lifitegrast compared with placebo (p=0.0007). They also noted that lifitegrast significantly reduced corneal fluorescein staining (superior, p=0.0392; total cornea, p=0.0148) and conjunctival lissamine staining (nasal, p=0.0039; total conjunctiva, p=0.0086) at day 84 versus placebo. Significant (p<0.05) improvements in nasal and total lissamine scores were observed at day 14 and maintained through day 84. The study did not meet the co-primary subjective VR-OSDI measure (p=0.7894). However, the study investigators did observe significant improvements at day 84 in ocular discomfort (p=0.0273) and eye dryness (p=0.0291), the most common and severe symptoms reported at baseline in both groups. There were no unanticipated or serious ocular adverse events (AEs). The most frequent reported ocular AEs were transient intermittent instillation site symptoms (irritation, discomfort) primarily on the initial lifitegrast dose at day zero.

Lifitegrast ophthalmic solution 5.0% significantly reduced corneal fluorescein and conjunctival lissamine staining and improved symptoms of ocular discomfort and eye dryness compared with placebo when administered twice daily over 84 days.

SOURCE: Sheppard JD, Torkildsen GL, Lonsdale JD, et al; OPUS-1 Study Group. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 Phase 3 study. Ophthalmology. 2014;121(2):475–483.





Potential Association Between Postmenopausal Hormone Use and POAG

Retinal ganglion cells are known to express estrogen receptors and prior studies have suggested an association between postmenopausal hormone (PMH) use and decreased intraocular pressure, suggesting that PMH use may decrease the risk for primary open-angle glaucoma (POAG).

This was a retrospective longitudinal cohort analysis of claims data from women 50 years or older enrolled in a U.S. managed care plan for at least four years in which enrollees had at least two visits to an eye-care provider during the period 2001 through 2009. The purpose of the analysis was to determine whether the use of three different classes of PMH affects the risk for POAG. Exposure was postmenopausal hormone medications containing estrogen only, estrogen + progesterone, and estrogen + androgen, as captured from outpatient pharmacy claims over a four-year period. The main outcome measure was hazard ratios (HRs) for developing incident POAG.

Of 152,163 eligible enrollees, 2,925 (1.9%) developed POAG. And after adjustment for confounding factors, each additional month of use of PMH containing estrogen only was associated with a 0.4% reduced risk for POAG (HR, 0.996 [95% CI, 0.993 to 0.999]; p=0.02). The risk for POAG did not differ with each additional month of use of estrogen + progesterone (HR, 0.994 [95% CI, 0.987 to 1.001]; p=0.08) or estrogen + androgen (HR, 0.999 [95% CI, 0.988 to 1.011]; p=0.89).

To conclude, use of PMH preparations containing estrogen may help reduce the risk for POAG. If prospective studies confirm the findings of this analysis, novel treatments for this sight-threatening condition may follow.

SOURCE: Newman-Casey PA, Talwar N, Nan B, et al. The potential association between postmenopausal hormone use and primary open-angle glaucoma. JAMA Ophthalmol. 2014;Jan 30. [Epub ahead of print].




  • OXFORD UNIVERSITY AND SYNCONA FORM NIGHTSTAR TO DEVELOP RETINAL GENE THERAPIES. Syncona LLP has announced a £12 million (~$19,672,578.17) investment in NightstaRx Ltd (“Nightstar”), a spinoff from the University of Oxford and its research commercialization company Isis Innovation. Nightstar will focus on the development and commercialization of therapies for retinal dystrophies. The company's first program is a gene therapy for choroideremia that uses a small modified virus to deliver the correct version of the choroideremia gene to cells in the retina. Nightstar has an exclusive license from Isis Innovation to the intellectual property that underpins this program.
  • ENVISION SELECTS KEYNOTE SPEAKER; ISSUES CALL FOR PRESENTATIONS AT 2014 CONFERENCE. Envision has selected Rebecca Kammer, OD, Diplomate Low Vision, FAAO, to present the keynote address at its 9th Annual Conference this September in Minneapolis. According to Envision, the conference provides a multidisciplinary approach to low vision research and rehabilitation, welcoming ophthalmologists, optometrists, occupational therapists, researchers, and others focused on improving the quality of low vision case through collaboration, advocacy, research and education. Dr. Kammer will address conference attendees on the subject of international development of low vision services.

    In related news, Envision is now accepting submissions of prospective Clinical Education and Research presentations relating to low vision research and rehabilitation for Conference 2014. Clinical Education submissions should include concrete examples and demonstrate the unique contribution and expertise of low vision practitioners and educators and should incorporate the principles of evidence-based practice. Accepted Clinical Education first presenters will have their transportation expenses reimbursed and will receive complimentary hotel stays at the conference hotel up to a night before and a night after the day of their presentations. Submissions should be made online by March 21, 2014. For more details on the conference or to register, visit www.envisionconference.org.
  • ABBOTT LAUNCHES TECNIS TORIC IOL IN JAPAN. Abbott recently made an announcement that its Tecnis Toric 1-Piece intraocular lens (IOL) has launched in Japan for the treatment of cataract patients with pre-existing corneal astigmatism. Not only does the Tecnis Toric 1-Piece lens provide astigmatism correction, but according to Abbott, it also minimizes spherical aberration to provide sharper distance vision for the patient. Additional information on the Tecnis Toric 1-Piece IOL can be found here.
  • NICOX S.A. APPOINTS NEW CFO. Nicox S.A. recently appointed Evelyne Nguyen as chief financial officer. As such, Mrs. Nguyen will lead the company's finance, legal and IT departments and will join the group's Executive Committee, reporting to Chairman and CEO Michele Garufi. She has 28 years of international experience in financial and administrative roles, including 20 years in the pharmaceutical and biotech industry.
  • EYELASH ENHANCING GEL NOW AVAILABLE FROM MEDINICHE. MediNiche Inc. has announced the introduction of new Lash Advance, a non-prescription product targeted to eye-care professionals that provides a natural, affordable cosmeceutical for healthier lashes and brows. MediNiche is positioning Lash Advance for eye-care practitioner recommendation to patients as a first step to healthier lashes and for use prior to or in conjunction with Allergan's Latisse. According to the company, Lash Advance is formulated with a blend of natural ingredients that help lashes recover from environmental, chemical and physical damage by hydrating, improving flexibility and minimizing breakage. MediNiche says that lashes return to a healthy state in as little as two weeks with regular use. Find out more about this product at www.mediniche.com.



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