Volume 12, Number 23
Monday, June 4, 2012

In this issue: (click heading to view article)
######### OCT in the Detection of Early Exudative AMD

######### Multifocal Electroretinograms in AMD Before and After PDT
######### Novel Integrin Antagonist (SAR 1118) for the Treatment of Dry Eye
######### Impact of Ginkgo Biloba Extract on VF Progression in NTG
######### Briefly




OCT in the Detection of Early Exudative AMD

Optical coherence tomography (OCT) provides microscopic retinal images and is noninvasive, using light waves to produce detailed retinal images. Researchers investigated the ability of OCT to detect early choroidal neovascularization (CNV) in age-related macular degeneration (AMD).

They enrolled 79 patients, diagnosed with nonexudative macular degeneration in one eye and exudative macular degeneration in the other in this prospective, observational, nonrandomized study. Participants underwent examination (visual acuity, intraocular pressure, biomicroscopy and ophthalmoscopy) followed by OCT in the study eye (nonexudative macular degeneration eye) every 3 months for 2 years. If examination did not show choroidal neovascularization, but OCT images raised suspicion, the researchers re-examined patients in 4 weeks to 6 weeks and/or performed fluorescein angiography. They also examined visual acuity, OCT anomaly detected and time between OCT and fluorescein angiography detection.

According to the study researchers, 15 (19%) patients developed exudative macular degeneration, as confirmed by fluorescein angiography, in the study eye. Four additional patients showed potential exudative macular degeneration on OCT only. Of the 15 patients who developed exudative macular degeneration, 13 had disease progression identified on OCT before examination and/or fluorescein angiography showed changes. The researchers noted that subretinal pigment epithelium fluid was the most common OCT anomaly, with development of sub-/intraretinal fluid also visible.

They concluded that OCT could be a powerful screening tool for patients with AMD at high risk for developing CNV.

SOURCE: Padnick-Silver L, Weinberg AB, Lafranco FP, Macsai MS. Pilot study for the detection of early exudative age-related macular degeneration with optical coherence tomography. Retina. 2012;32(6):1045–1056.

Multifocal Electroretinograms in AMD Before and After PDT

To evaluate multifocal electroretinograms (mfERG) and macular retinal thickness before and after photodynamic therapy (PDT) for predominantly classic choroidal neovascularization (CNV) (classic type) and occult with no classic CNV (occult type), the authors of the following study recorded mfERG and measured macular retinal thickness before and after PDT in 19 patients (19 eyes) with the classic type and 24 (26 eyes) with the occult type.

The evaluation items were the amplitude of the first negative wave (N1), the amplitude from the peak of the negative wave to that of the following positive wave (P1) and the peak latencies of the negative and positive waves.

The authors reported that compared with mfERG before PDT, mfERG after PDT showed a significant decrease in the P1 latency in the central area (31.1±1.9 ms before and 29.6±1.6 ms after PDT) for the classic type and significant decreases in both the central (32.0±2.0 ms before and 30.5±2.4 ms after PDT) and peripheral (30.2±2.0 ms before and 29.5±2.0 ms after PDT) areas for the occult type. They also observed that optical coherence tomography showed significant decreases in macular retinal thickness in both groups (464 and 314 µm before and after PDT, respectively, for the classic type and 516 and 340 µm for the occult type).

Following PDT, retinal function evaluated by mfERG improved for both the classic and occult types, and the recovery of P1 latency may be due to improvement in retinal edema.

SOURCE:Kojima M, Yukawa E, Shimoyama K, et al. Multifocal electroretinograms in age-related macular degeneration before and after photodynamic therapy. Eur J Ophthalmol. 2012;22(3):412–416.


Novel Integrin Antagonist (SAR 1118) for the Treatment of Dry Eye

The following multicenter, prospective, double-masked, placebo-controlled trial investigated the efficacy and safety of an investigational integrin antagonist (SAR 1118) ophthalmic solution compared to placebo (vehicle) in subjects with dry eye disease.

A total of 230 dry eye subjects selected with use of a controlled adverse environment were randomized 1:1:1:1 to receive SAR 1118 (0.1%, 1.0%, 5.0%) or placebo eye drops twice daily for 84 days. Principal eligibility criteria included exacerbation in corneal staining and ocular symptoms with controlled adverse environment exposure, no active lid margin disease, and Schirmer test (mm/5 min) >1 and <10. Ocular signs and symptoms (Ocular Surface Disease Index, OSDI) were assessed at day 14, 42, and 84. No supplemental artificial tears were allowed. Primary outcome measure was inferior corneal staining score at day 84.

A dose response for the corneal staining score (p = .0566) was observed for SAR 1118 at day 84 compared to placebo and it was reported that a mean change from baseline to day 84 showed significant improvements (p < .05) in corneal staining score, total OSDI and visual-related function OSDI scores for SAR 1118 compared to placebo; improvements in tear production and symptoms were observed as early as day 14 (p < .05). Adverse events were mild and transient in nature with no serious ocular adverse events. SAR 1118 5.0% showed increased instillation site adverse events relative to placebo but were limited to the initial dose.

To conclude, SAR 1118 demonstrated improvements in signs and symptoms of dry eye compared to placebo and appears safe when administered over 84 days.

SOURCE: Semba CP, Torkildsen GL, Lonsdale JD, et al. A phase 2 randomized, double-masked, placebo-controlled study of a novel integrin antagonist (SAR 1118) for the treatment of dry eye. Am J Ophthalmol. 2012;153(6):1050–1060.



Impact of Ginkgo Biloba Extract on VF Progression in NTG

In this retrospective study, investigators evaluated the long-term effect of Ginkgo biloba extract (GBE) on progression of visual field (VF) defects in patients with normal tension glaucoma (NTG). They evaluated 42 eyes of 42 patients with treated NTG who received 80 mg GBE 2 times daily and who had at least 5 VF tests using the Humphrey Visual Field Analyzer for more than a 4-year period before and after GBE treatment.

They also evaluated the change of progression rate using mean deviation (MD), pattern standard deviation (PSD) and visual field index (VFI) after GBE treatment. Additionally, the investigators analyzed time course of mean total deviation in 10 zones corresponding to the glaucoma hemifield test using a linear mixed effects model with unequal random effect variances.

They noted that the mean follow-up period was 12.3 years and found that the post-therapeutic IOPs before and after GBE treatment were not significantly different (p=0.509 paired t test). The study investigators also reported that before GBE treatment, the regression coefficients (RCs) of MD, PSD and VFI change were –0.619 dB/y, 0.626 dB/y, and –2.153%/y, respectively. After GBE treatment, the RCs of MD, PSD, and VFI change improved significantly to –0.379 dB/y, 0.342 dB/y, and –1.212%/y (p <0.001), respectively. In zone 1, the RC of mean total deviation change was significantly increased after GBE administration (p <0.005).

In conclusion, GBE administration slowed the progression of VF damage in patients with NTG, especially in zone 1 corresponding to the superior central field.

SOURCE: Lee J, Sohn SW, Kee C. Effect of ginkgo biloba extract on visual field progression in normal tension glaucoma. J Glaucoma. 2012; May 16. [Epub ahead of print].


  • OMEROS TO INITIATE PLANNED PHARMACOKINETIC SUBSTUDY OF OMS302 PHASE 3 CLINICAL PROGRAM. In a recent press release, Omeros Corporation announced the initiation of the planned pharmacokinetic (PK) substudy in its Phase 3 clinical program evaluating OMS302 in patients undergoing intraocular lens replacement (ILR) surgery. (OMS302 is added to standard irrigation solution used during ILR procedures to maintain intraoperative mydriasis and reduce postop pain.) The company is conducting the PK substudy to confirm the low levels of systemic exposure previously observed in preclinical studies of the drug product. Blood samples will be collected prior to and during the first 24 hours after surgery from each of 12 OMS302- and placebo-treated patients in the ongoing second OMS302 Phase 3 clinical trial. Omeros says that these data will be included in its OMS302 marketing applications in the United States and the European Union.
  • GLAUKOS COPORATION HONORED WITH RED HERRING AWARD. Glaukos Corporation has been selected as a Red Herring Top 100 North America tech Startup, a prestigious award honoring the year's most promising private technology ventures from the North American business region. The Red Herring editorial team selected the most innovative companies from a pool of hundreds from across North America and evaluated them on both quantitative and qualitative criteria such as financial performance, technology innovation, management quality, strategy and market penetration. Visit the company's website to learn more. To see the list of 2012 Top 100 Americas, click here.
  • BAUSCH + LOMB LAUNCHES NEW 1-DAY CONTACT LENS IN EUROPE. Bausch + Lomb recently launched Biotrue ONEday daily disposable contact lenses. Made from HyperGel material, the lens contains 78% water. Its outer surface was designed to mimic the lipid layer of tear film, which prevents dehydration of the lens. Biotrue ONEday lenses are being introduced initially in Italy, followed by the U.K. and Nordics later in the year. Learn more about this new lens here.


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