Volume 14, Number 22
Monday, June 2, 2014

In this issue: (click heading to view article)
######### Efficacy of Intravitreal Anti-VEGF Therapy for Vascularized PED in AMD
######### Use of Azithromycin 1.5% Eye Drops in a Pediatric Population with Purulent Bacterial Conjunctivitis
######### Clinical Characteristics of Reticular Pseudodrusen in the Fellow Eye of Patients with Unilateral Neovascular AMD
######### Outcomes of Intravitreal Aflibercept Use in Eyes with Recalcitrant Neovascular AMD
######### Briefly

Efficacy of Intravitreal Anti-VEGF Therapy for Vascularized PED in AMD

In Italy, researchers assessed the efficacy of intravitreal anti-vascular endothelial growth factor (VEGF) treatment of vascularized pigment epithelial detachment (PED) due to age-related macular degeneration (AMD).

They retrospectively analyzed and treated 26 patients with vascularized PED secondary to AMD with anti-VEGF intravitreal injections according to a p.r.n. regimen after three initial injections. They performed best-corrected visual acuity (BCVA), optical coherence tomography, and fluorescein angiography at baseline and quarterly.

Mean follow-up ranged from nine to 26 months (mean 13.5) and according to the researchers, there was a deterioration in mean BCVA from 0.46 at baseline to 0.79 logMAR at 12 months (p<0.001). They noted that the mean PED greatest linear diameter (GLD) increased from 4,499 at baseline to 5,206 µm at one-year follow-up (p<0.001). They also reported that mean PED maximum height decreased from 669 µm at baseline to 305 µm at one-year follow-up (p=0.001). The mean central retinal thickness (CRT) was unchanged (from 277 to 209 µm at one year follow-up) (p=0.099). No effect was seen on the change of VA according to groups of baseline predictors as defined by the medial value: baseline VA, PED height, and CRT (p>0.10). There was a borderline trend (p=0.064) that GLD affected response to treatment. The mean number of injections was 5.5 (three to nine). Seven out of 26 (27%) patients developed a retinal pigment epithelium (RPE) tear.

Intravitreal anti-VEGF therapy, with a p.r.n. regimen, did not prevent visual acuity loss or RPE tear, the study researchers concluded.

SOURCE: Giansanti F, Bacherini D, Giacomelli G, et al. Intravitreal anti-VEGF therapy for vascularized pigment epithelium detachment in age-related macular degeneration. Eur J Ophthalmol. 2014;24(3):402–408.



Use of Azithromycin 1.5% Eye Drops in a Pediatric Population with Purulent Bacterial Conjunctivitis

This multicenter, international, randomized, investigator-masked study sought to determine the efficacy and safety of azithromycin 1.5% eye drops in a pediatric population of 286 children with purulent discharge and bulbar conjunctival injection.

Patients received either azithromycin 1.5% eye drops (b.id. for three days) or tobramycin 0.3% eye drops (q.2.h. for two days, then q.i.d. for five days). Clinical signs were evaluated on day zero, three and seven, and cultures on day zero and day seven. The primary variable was the clinical cure (absence of bulbar conjunctival injection and discharge) on day three in the worse eye for patients with positive cultures on day zero.

A total of 286 patients (mean age 3.2 years; range one day to 17 years) were included; 203 had positive cultures on day zero. Azithromycin was superior to tobramycin in clinical cure rate on day three (47.1% vs. 28.7%, p=0.013) and was noninferior to tobramycin on day seven (89.2% vs. 78.2%, respectively). It was also noted that azithromycin treatment eradicated causative pathogens, including resistant species, with a similar resolution rate to tobramycin (89.8% vs. 87.2%, respectively). These results were confirmed in a subgroup of patients younger than 24 months old.

To conclude, azithromycin 1.5% eye drops provided a more rapid clinical cure than tobramycin 0.3% eye drops in the treatment of purulent bacterial conjunctivitis in children, with a more convenient b.i.d. dosing regimen.

SOURCE: Bremond-Gignac D, Nezzar H, Bianchi PE, et al. Efficacy and safety of azithromycin 1.5% eye drops in paediatric population with purulent bacterial conjunctivitis. Br J Ophthalmol. 2014;98(6):739–745.

Clinical Characteristics of Reticular Pseudodrusen in the Fellow Eye of Patients with Unilateral Neovascular AMD

The authors of the following cohort study recruited 105 patients (age range 52 to 93 years) who had advanced neovascular age-related macular degeneration (AMD) in only one eye from three clinical centers in Europe to describe associations between reticular pseudodrusen, individual characteristics, and retinal function.

Minimum follow-up was 12 months and the eye selected for study was the fellow eye without advanced disease. The study authors noted that clinical measures of vision were distance visual acuity, near visual acuity, and results of the Smith-Kettlewell low-luminance acuity test (SKILL). Fundus imaging included color photography, red-free imaging, blue autofluorescence imaging, fluorescein angiography, indocyanine green angiography, and optical coherence tomography using standardized protocols. The authors used these to detect progression to neovascular AMD in the study eye during follow-up. They also graded all imaging outputs for the presence or absence of reticular pseudodrusen (RPD) using a multimodal approach. Additionally, they measured choroidal thickness at the foveal center and at two other equidistant locations from the fovea (1500 µm) nasally and temporally. Metrics on retinal thickness and volume were obtained from the manufacturer-supplied automated segmentation readouts. The main outcome measures were presence of RPD, distance visual acuity, near visual acuity, SKILL score, choroidal thickness, retinal thickness, and retinal volume.

The authors found reticular pseudodrusen in 43 participants (41%) on one or more imaging method, and they reported that the SKILL score was significantly worse in those with reticular drusen (mean score ± standard deviation [SD, 38 ± 12) versus those without (mean score ± SD, 33 ± 9) (p=0.034). Parafoveal retinal thickness, parafoveal retinal volume, and all of the choroidal thickness parameters measured were significantly lower in those with reticular drusen than in those without. The authors associated presence of RPD with development of neovascular AMD when corrected for age and sex (odds ratio, 5.5; 95% confidence interval, 1.1 to 28.8; p=0.042). Furthermore, all participants in whom geographic atrophy developed during follow-up had visible RPD at baseline.

Significant differences in retinal and choroidal anatomic features, visual function, and risk factor profile exist in unilateral neovascular AMD patients with RPD compared with those without; therefore, such patients should be monitored carefully because of the risk of developing bilateral disease.

SOURCE: Hogg RE, Silva R, Staurenghi G, et al. Clinical characteristics of reticular pseudodrusen in the fellow eye of patients with unilateral neovascular age-related macular degeneration. Ophthalmology. 2014;May 22. [Epub ahead of print].

Outcomes of Intravitreal Aflibercept Use in Eyes with Recalcitrant Neovascular AMD

Investigators described the efficacy of intravitreal aflibercept on 12-month visual and anatomical outcomes in patients with neovascular age-related macular degeneration (AMD) recalcitrant to prior monthly intravitreal bevacizumab or ranibizumab in this non-comparative case series.

In this series, they examined 21 eyes of 21 AMD patients with evidence of persistent exudation (intraretinal fluid/cysts, or subretinal fluid [SRF], or both) on spectral-domain optical coherence tomography despite six or more prior intravitreal 0.5 mg ranibizumab or 1.25 mg bevacizumab (mean 29.8 ± 17.1) injections over 31.6 ± 17.4 months who were transitioned to aflibercept.

At baseline, best-corrected visual acuity (BCVA) was 0.42 ± 0.28 logarithm of minimum-angle of resolution (logMAR), central foveal thickness (CFT) was 329.38 ±102.67  µm and macular volume (MV) was 7.71 ± 1.32 mm³, the investigators noted. After 12 months of aflibercept (mean 10.2 ±1.2 injections), they reported that BCVA was 0.40 ± 0.28 logMAR (p=0.5), CFT decreased to 292.71 ± 91.35 µm (p=0.038) and MV improved to 7.33 ± 1.27 mm³ (p=0.003). In a subset of 15 eyes with a persistent fibrovascular or serous pigment epithelial detachment (PED), mean baseline PED greatest basal diameter (GBD) was 2350.9 ± 1067.6  µm and mean maximal height (MH) was 288.7 ± 175.9  µm. At 12 months, GBD improved to 1896.3 ± 782.3  µm (p=0.028), while MH decreased to 248.27 ± 146.2  µm (p=0.002).

It was discovered that, in patients with recalcitrant AMD, aflibercept led to anatomic improvement at 12 months, reduction in proportion of eyes with SRF and reduction in PED, while preserving visual acuity.

SOURCE: Grewal DS, Gill MK, Sarezky D, et al. Visual and anatomical outcomes following intravitreal aflibercept in eyes with recalcitrant neovascular age-related macular degeneration: 12-month results. Eye. 2014;May 16. [Epub ahead of print].

  • ALLERGAN REVIEWING REVISED, UNSOLICTED PROPOSAL FROM VALEANT. In a recent press release, Allergan confirmed that it has received a revised, unsolicited proposal from Valeant Pharmaceuticals International Inc. to acquire all of the outstanding shares of Allergan for a combination of 0.83 of Valeant shares, $58.30 in cash per share of common stock for the company, and a contingent value right (CVR) related to DARPin sales (the “Revised Proposal”). The Allergan board of directors unanimously concluded that Valeant's original proposal from April substantially undervalued Allergan, created significant risks and uncertainties for the stockholders of Allergan, and was not in the best interests of the company and its stockholders. Allergan's board will carefully review and consider the revised proposal and pursue the course of action that it believes is in the best interests of the company and its stockholders.

  • CHMP ISSUES POSITIVE OPINION FOR SIMBRINZA. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Simbrinza eye drops suspension (brinzolamide 10 mg/mL and brimonidine tartrate 2 mg/mL) to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for whom monotherapy provides insufficient IOP reduction. The CHMP opinion was based on two pivotal Phase III clinical trials, evaluating the safety and efficacy of Simbrinza administered twice daily. Read more here.

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