Volume 14, Number 2
Monday, January 13, 2014


In this issue: (click heading to view article)
######### Fluctuation in IOP in Patients Who Have POAG Plus High Myopia

######### An Evaluation of the Risk of GA

######### AMD and AREDS: 10-Year Follow-Up
######### Dry-Eye: Prevalence, Risk Factors and Health-Related Quality of Life
######### Briefly


Fluctuation in IOP in Patients Who Have POAG Plus High Myopia

Here, the authors of a prospective control clinical study investigate whether patients with primary open-angle glaucoma (POAG) combined with high myopia (POAG-HM) have short-term intraocular pressure (IOP) fluctuations at resting conditions over 24 hours and after dynamic exercise.

They categorized 80 eyes of 80 high-tension Chinese POAG patients only on prostaglandin analog locally as per their degree of myopia (myopes ≥6D, n=30 and between –0.76D and –5.99D, n=29) or without myopia (n=21). They observed 24-hour IOP fluctuations at resting conditions in protocol one, and IOP fluctuations after 10-minute exercise at 20% maximum Watt (Wmax) followed by five minutes of exercise at 60% Wmax in protocol two.

The study authors noted that 24-hour IOP fluctuations at resting conditions were not statistically significant among groups (p=0.58). They also found that, after 10 minutes of moderate (20% Wmax) exercise, patients with POAG-HM had significant IOP decrease (3.50 ± 2.76 mmHg) over other subjects (analysis of covariance, age, as a covariate, was controlled, p=0.02). After five minutes of heavy (60% Wmax) exercise, patients with POAG-HM had significantly a greater postexercise IOP decrease (7.57 ± 3.47 mmHg) than other groups (p=0.00).

In conclusion, high-tension POAG patients with high myopia on only pharmacological glaucoma therapy have significantly greater IOP fluctuations after moderate and heavy exercise and do not have greater 24-hour IOP fluctuations at resting conditions.

SOURCE: Yang Y, Li Z, Wang N, et al. Intraocular pressure fluctuation in patients with primary open-angle glaucoma combined with high myopia. J Glaucoma. 2014; 23(1):19–22.

An Evaluation of the Risk of GA

To describe risk factors for geographic atrophy (GA) in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT), researchers used a cohort within the randomized clinical trial to analyze 1,024 CATT patients with no GA visible on color fundus photographs (CFPs) and/or fluorescein angiograms (FAs) at enrollment.

They assigned eyes to ranibizumab (0.5 mg) or bevacizumab (1.25 mg) treatment and to a two-year monthly or pro re nata (p.r.n.) injection regimen, or monthly injections for one year and p.r.n. for one year. They evaluated demographic, genetic and baseline ocular characteristics, as well as lesion features of CFP/FA and optical coherence tomography (OCT) as risk factors for GA through two years of follow-up. Time-dependent Cox proportional hazard models were used to estimate adjusted hazard ratios (aHRs). Devlopment of GA was the main outcome measure.

According to the researchers, by two years, GA developed in 187 of 1,024 patients (18.3%). Baseline risk factors for GA development included baseline visual acuity (VA) ≤20/200 (aHR, 2.65; 95% confidence interval [CI], 1.43 to 4.93), retinal angiomatous proliferation (RAP; aHR, 1.69; 95% CI, 1.16 to 2.47), GA in the fellow eye (aHR, 2.07; 95% CI, 1.40 to 3.08) and intraretinal fluid at the foveal center (aHR, 2.10; 95% CI, 1.34 to 3.31). The study researchers reported that baseline factors associated with lower risk for GA development included blocked fluorescence (aHR, 0.49; 95% CI, 0.29 to 0.82), OCT measurements of subretinal fluid thickness of >25 µm (aHR, 0.52; 95% CI, 0.35 to 0.78), subretinal tissue complex thickness of >275 compared with ≤75 µm (aHR, 0.31; 95% CI, 0.19 to 0.50) and vitreomacular attachment (aHR, 0.55; 95% CI, 0.31 to 0.97). They also noted that ranibizumab compared with bevacizumab had a higher risk (aHR, 1.43; 95% CI, 1.06 to 1.93), and monthly dosing had a higher risk (aHR, 1.59; 95% CI, 1.17 to 2.16) than p.r.n. dosing. They found no strong associations between development of GA and the presence of risk alleles for CFH, ARMS 2, HTRA1, C3 or TLR3.

Approximately one-fifth of CATT patients developed GA within two years of treatment. Independent baseline risk factors included poor VA, RAP, foveal intraretinal fluid, monthly dosing and treatment with ranibizumab. Anti-vascular endothelial growth factor therapy may have a role in the development of GA.

SOURCE: Grunwald JE, Daniel E, Huang J, et al.; CATT Research Group. Risk of geographic atrophy in the Comparison of Age-related macular degeneration Treatment Trials. Ophthalmology. 2014;121(1):150–161.


AMD and AREDS: 10-Year Follow-Up

Participants of the Age-Related Eye Disease Study (AREDS) were observed for an additional five years after a randomized clinical trial of antioxidant vitamins and minerals was completed to describe 10-year progression rates to intermediate or advanced age-related macular degeneration (AMD).

Observation occurred at 11 clinical sites of medical retinal practices from academic institutions and community medical centers. Participants aged 55 to 80 years with no AMD or AMD of varying severity (n=4,757) were followed up in the AREDS trial for a median duration of 6.5 years and when the trial ended, 3,549 of the 4,203 surviving participants were followed for five additional years. Exposure consisted of treatment with antioxidant vitamins and minerals. The main outcome measure was the development of varying stages of AMD and changes in visual acuity. The rates of progression to large drusen and advanced AMD (neovascular AMD or central geographic atrophy [GA]) were evaluated using annual fundus photographs assessed centrally. Best-corrected visual acuity was measured at annual study visits.

The risk of progression to advanced AMD increased with increasing age (p=0.01) and severity of drusen. Women (p=0.005) and current smokers (p<0.001) were at increased risk of neovascular AMD. In the oldest participants with the most severe AMD status at baseline, the risks of developing neovascular AMD and central GA by 10 years were 48.1% and 26.0%, respectively. Similarly, rates of progression to large drusen increased with increasing severity of drusen at baseline, with 70.9% of participants with bilateral medium drusen progressing to large drusen and 13.8% to advanced AMD in 10 years. Median visual acuity at 10 years in eyes that had large drusen at baseline but never developed advanced AMD was 20/25; eyes that developed advanced AMD had a median visual acuity of 20/200.

To conclude, the natural history of AMD demonstrates relentless loss of vision in persons who developed advanced AMD. These progression data and the risk factor analyses may be helpful to investigators conducting research in clinic populations.

SOURCE: Chew EY, Clemons TE, Agrón E, et al; for the Age-Related Eye Disease Study Research Group. Ten-year follow-up of age-related macular degeneration in the age-related eye disease study: AREDS Report No. 36. JAMA Ophthalmol. 2014; Jan 2. [Epub ahead of print].

Dry-Eye: Prevalence, Risk Factors and Health-Related Quality of Life

Investigators in this cohort study sought to estimate dry-eye prevalence in the Beaver Dam Offspring Study (BOSS), including a young adult population, and investigate associated risk factors and impact on health-related quality of life.

The BOSS (2005 to 2008) is a study of aging in the adult offspring of the population-based Epidemiology of Hearing Loss Study cohort. Questionnaire data on health history, medication use, risk factors and quality of life were available for 3,275 participants. Dry eye was determined by self-report of frequency of symptoms and the intensity of those symptoms. The study investigators analyzed associations between dry eye and risk factors using logistic regression.

They noted that the prevalence of dry eye in the BOSS was 14.5% (17.9% of women and 10.5% of men). In a multivariate model, they found statistically significant associations with female sex (odds ratio (OR), 1.68; 95% confidence interval (CI), 1.33 to 2.11), current contact lens use (OR, 2.01; 95% CI, 1.53 to 2.64), allergies (OR, 1.59; 95% CI 1.22 to 2.08), arthritis (OR, 1.44; 95% CI, 1.12 to 1.85), thyroid disease (OR, 1.43; 95% CI, 1.02 to 1.99), antihistamine use (OR, 1.54; 95% CI, 1.18 to 2.02) and steroid use (OR, 1.54; 95% CI, 1.16 to 2.06). Dry eye was also associated with lower scores on the Medical Outcomes Short Form-36 (β=–3.9, p<0.0001) as well as on the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) (β=–3.4, p<0.0001) when controlling for age, sex and comorbid conditions.

The study investigators concluded that the prevalence of dry eye and its associated risk factors in the BOSS were similar to previous studies. In this study, DES was associated with lower quality of life on a health-related quality of life instrument and the vision-specific NEI-VFQ-25.

SOURCE: Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the Beaver Dam Offspring Study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014;Jan 3. [Epub ahead of print].

  • KALA PHARMACEUTICALS SUBMITS IND FOR MMP-FORMULATED LOTEPREDNOL ETABONATE FOR POST-CATARACT SURGERY. In a recent press release, Kala Pharmaceuticals Inc. announced that it has submitted an Investigational New Drug (IND) application to the FDA to initiate a Phase III clinical program with its MPP-formulated loteprednol etabonate ophthalmic nano-suspension product (LE-MPP) for the treatment of postoperative inflammation and pain following cataract surgery. Kala's proprietary MPP technology platform allows therapeutic agents to pass through the mucus layer of the ocular surface, facilitating penetration into deeper tissues of the eye, including the aqueous humor and retina. The company's MPPs are designed to potentiate pharmacological effects within target tissues. The objective of the upcoming clinical trial with Kala's LE-MPP product is to demonstrate anti-inflammatory efficacy similar to that of other steroid-based treatments with less frequent (twice-daily) dosing while maintaining the safety profile of current loteprednol etabonate products.
  • POSITIVE RESULTS REPORTED FOR AERIE'S LEAD CANDIDATE AR-13324 IN NORMOTENSIVE INDIVIDUALS. Aerie Pharmaceuticals Inc. has reported top-line results from its recently completed Phase I pharmacokinetics (PK) study, in which AR-13324 eye drops were administered once-daily to 18 healthy individuals over an eight-day period to assess systemic exposure to the drug. In addition to the primary PK outcome of the study, the drug’s effect on intraocular pressure (IOP) was also measured. The PK results demonstrated very low systemic exposure to the drug, with blood levels at or below the limit of detection of 0.1 ng/mL at all time points. There were no drug-related effects on systemic safety parameters such as blood pressure and heart rate. After eight days of dosing, once-daily administration of AR-13324 reduced the average diurnal IOP to approximately 11 mmHg, representing a decrease of approximately 5 mmHg, or more than 30%. Phase III registration studies of AR-13324 are expected to commence by mid-2014. Get more information here.
  • LACRIVERA LAUNCHES DRY EYE LINE. Lacrivera, a division of Stephens Instruments, has announced the launch of its dry eye product line. Offerings will include the VeraPlug Punctal Occluder, which will be available in sterile pre-loaded and non-sterile bulk packagings, as well as VeraC7 Collagen, Vera90 Extended Wear Plug, diagnostic tests and additional products that help to treat dry-eye patients. Visit the company's website for more information.

  • IN-OFFICE LENS SURFACING SYSTEM TO DEBUT AT MIDO. Italy Super Systems will be showcasing its all-new in-office lens surfacing system, Fastgrind, at the 2014 MIDO Optical Fair in Milan, Italy. Fastgrind will be operating on the latest software design, 7.92c, which was updated to enhance the user experience, improve the efficiency of the machine and implement the capabilities to produce new digital lens types. All Fastgrind customers can stay up-to-date with access to a special section of the company's website: www.superoptical.com, where they can download the newest software training videos and manuals. Here, customers can also browse and order from Super Systems' lens inventory and optical equipment selection.

  • NEW APP AIDS ECPS IN KERASOFT IC LENS SELECTION FOR PATIENTS WITH IRREGULARLY SHAPED CORNEAS. Bausch + Lomb recently introduced the MoRoCCo VA app in the United States to help eye-care professionals (ECPs) select the correct KeraSoft IC lens for patients with keratoconus and other corneal irregularities. Based on the MoRoCCo VA fitting method, the company says the app guides ECPs through each stage of the lens fitting process. And, using interactive screens, the app allows ECPs to directly enter data during each KeraSoft IC lens fitting assessment, then provides instantaneous feedback as to whether the fit is optimal or sub-optimal, and offers advice on logical next steps. Aside from being able to store fitting data for both eyes in one session, other benefits include real-time animations of lens behavior, fitting history for each patient at a glance, ability to email lens orders to authorized laboratories and request technical support. Designed for use on multiple electronic devices, the MoRoCCo VA app is browser-based and available at no cost.


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