Volume 6, Number 7
July 2010

 

WELCOME to Review of Ophthalmology's Retina Online e-newsletter. Each month, Medical Editor Philip Rosenfeld, MD, PhD, and our editors provide you with this timely and easily accessible report to keep you up to date on important information affecting the care of patients with vitreoretinal disease.



Lucentis Receives FDA Approval for the Treatment of Macular Edema Following RVO
After a six-month Priority Review, the FDA recently approved Genentech, Inc.'s Lucentis (ranibizumab injection) for the treatment of macular edema...

Study Finds Iridex Micropulse Laser Effectively Treats DME
Iridex Corporation recently announced the recent publication of a clinical study...

And More...

Impact of Variable Ranibizumab Dosing Regimen and One-Time Reduced-Fluence PDT on Neovascular AMD

Belgium researchers carried out this prospective, nonrandomized, open-label, single-center study to demonstrate long-term prevention of vision loss and improvement in best-corrected visual acuity (BCVA) after treatment with one-time reduced-fluence-rate verteporfin photodynamic therapy (PDT) followed by administration of ranibizumab on a variable dosing regimen over 24 months in patients with neovascular age-related macular degeneration (AMD). Secondary outcome measures included the change in central macular thickness (CMT, reinjection frequency and safety.

The researchers enrolled 27 consecutive patients (27 eyes) presenting at the Leuven University Eye Hospital with previously untreated, active neovascular AMD between September 2006 and January 2007. They treated all patients with one-time, reduced-fluence-rate verteporfin PDT, followed by intravitreal ranibizumab 0.5 mg on the same day. They then gave a second and third ranibizumab injection at weeks 4 and 8, respectively, after which they followed up with patients for 24 months. The study researchers administered additional treatment with ranibizumab to eyes with active neovascularization as indicated clinically and on imaging studies. They based retreatment on the following criteria (1) presence of subretinal fluid (SRF), intraretinal edema or sub-retinal pigment epithelial fluid, as seen on OCT; (2) increase of CMT by >100 mm on OCT; (3) signs of active CNV leakage on fluroescein angiography; (4) new sub- or intraretinal hemorrhage; and (5) BCVA decrease of ≥5 letters on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. If any single criterion for reinjection was fulfilled, the researchers administered retreatment with ranibizumab.

A total of 25 patients completed the 2-year study. The researchers noted that occult CNV was present in 64% and retinal angiomatous proliferative (RAP) lesions were present in 24% of the study eyes. The remaining three eyes had lesions classified as classic (one eye) or predominantly classic (two eyes) CNV. Month 24 data are available for 25 eyes (25 patients; age 55–86 years; mean 77; standard deviation (SD) = 7.2). The researchers noted that mean baseline VA was 58.6 letters (range: 35–70; SD=8.4); 24-month VA was 66.2 letters (35–82; 12.7), not including one warfarin-treated patient who suffered vitreous hemorrhage. They also reported that the mean VA improved by 7.2 letters (p<0.05) and the mean CMT decreased by 146 µm. VA improved >3 lines (15 letters) in 16%; improved 1–3 lines in 20%; remained within one line of baseline in 32%, decreased 1–3 lines in 16% and decreased >3 lines in 16%. According to the researchers, losses of >3 lines were due to vitreous hemorrhage, geographic atrophy, fibrosis and growth of an initially small CNV lesion. They administered an average of 5.1 injections (range: 3–9) during the first 12 months, and 7.1 injections (3–13) over 24 months. Moreover, they performed a total of 178 injections; they observed no systemic side effects, uveitis or choroidal collateral vascular damage. Two patients were lost to follow up.

Combined PDT and ranibizumab injection the same day was well tolerated in all patients, the researchers noted. A total of 84% of patients had stable or improved vision at month 24.

Source: Spielberg L, Leys A. Treatment of neovascular age-related macular degeneration with a variable ranibizumab dosing regimen and one-time reduced-fluence photodynamic therapy: the TORPEDO trial at 2 years. Graefes Arch Clin Exp Ophthalmol 2010;248(7):943-956.


Efficacy of Intravitreal Bevacizumab in Vascular PED Due to Subfoveal Occult CNV in AMD

In this retrospective study, investigators evaluated the effect of intravitreally administered bevacizumab on untreated vascularized pigment epithelium detachment (PED) in sub- or juxtafoveal ocular choroidal neovascularization (CNV) as a result of age-related macular degeneration (AMD).

They treated 28 untreated eyes of 26 patients (4 men, 22 women; mean age, 74.6 ± 7.2 years) with PED and sub- or juxtafoveal occult CNV as a result of AMD and additional intra- and/or subretinal fluid with intravitreal injections of 1.25 mg bevacizumab. Baseline and follow-up visits included best-corrected visual acuity (BCVA), complete ophthalmic examination and Stratus optical coherence tomography (OCT). The investigators performed fluorescein angiography at baseline and, if intra- and/or subretinal fluid persisted or recurred or PED increased, reinjections.

They noted that patients received 3.2 ± 1.8 injections (follow up 37.9 ± 18.3 weeks) and that mean maximum PED height showed a tendency to decrease (372 ± 150.5 µm to 290.3 ± 189 µm; p=0.094). They also reported that in 14 eyes (53.8%), PED height was reduced at last visit, including complete flattening in 1 eye. Mean visual acuity remained stable (0.58 ± 0.30 logarithm of the minimum angle of resolution to 0.58 ± 0.37 logarithm of the minimum angle of resolution; p=0.905). Pigment epithelium detachment response to treatment did not correlate with baseline PED height or visual acuity at baseline or at the last visit, according to the investigators. Additionally, one patient sustained a retinal pigment epithelium rip, and another patient sustained an extensive subretinal hemorrhage.

The study investigators determined that during bevacizumab therapy, mean PED height decreases in 50% of patients. They could not identify any predictive factors for the response of PED to bevacizumab treatment and concluded that treatment of PED with bevaicuzmab might result in a long-term functional benefit compared with the natural course.

Source: Ach T, Hoeh A, Ruppenstein M, et al. Intravitreal bevacizumab in vascular pigment epithelium detachment as a result of subfoveal occult choroidal neovascularization in age-related macular degeneration. Retina 2010; June 10 [Epub ahead of print]. DOI: 10.1097/IAE.0b013e3181d87e97.


Treatment of Neovascular AMD with RNAi-Based Sirna-027

The purpose of this prospective, open-label, single-dose, dose-escalation phase I study was to assess the safety, tolerability, pharmacokinetics, and dose-limiting toxicity of single intravitreal injection of Sirna-027, a small interfering RNA targeting vascular endothelial growth factor (VEGF) receptor-1, in patients with choroidal neovascularization (CNV) resulting from neovascular age-related macular degeneration (AMD). Secondary objectives included assessment of anatomic changes in retinal thickness, size of CNV, and changes in visual acuity.

A total of 26 eyes of 26 patients with a median age of 82 years and CNV resulting from AMD who had previous treatments with other therapies were treated at two academic retinal practices. It was reported that patients received a single dose of Sirna-027 (100, 200, 400, 800, 1200, or 1600 g/eye) and that blood was sampled for pharmacokinetic analysis at 1, 4, and 24 hours after injection and on day 7. Patients underwent ophthalmic examinations including visual acuity, fluorescein angiography, and optical coherence tomography at screening and days 7, 14, 28, and 84. The main outcome measures were adverse reactions and dose-limiting toxicities.

It was noted that intravitreal injection of a single dose of Sirna-027 from 100 to 1600 g was well tolerated in patients with AMD, with no dose-limiting toxicity found. Adverse events were mild to moderate in severity and adjusted mean foveal thickness decreased within 2 weeks after study treatment. The decrease was most pronounced in the 100- and 200-g doses.

In conclusion, a single intravitreal dose of Sirna-027 up to 1600 _g/eye was well tolerated in patients with CNV resulting from neovascular AMD that had been refractory to other therapies. Additionally, stabilization or improvement in visual acuity and foveal thickness was observed and no dose-response or dose-limiting effects were noted.

Source: Kaiser PK, Symons RC, Shah SM, et al. RNAi-based treatment for neovascular age-related macular degeneration by Sirna-027. Am J Ophthalmol 2010;150(1):33-39.


Incidence of New CNV in Fellow Eyes of Patients Treated in Two Clinical Trials

Researchers conducted this retrospective data analysis of randomized, controlled clinical trials to explore whether monthly intravitreal ranibizumab injections are associated with a lower rate of new choroidal neovascularization (CNV) in fellow eyes of patients with unilateral neovascular age-related macular degeneration (AMD).

They calculated incidence of new CNV in fellow eyes at 12 and 24 months from two clinical trials (the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA] study and the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR] study), based on fluorescein angiographic reading center criteria and investigator evaluation. They compared patients treated with monthly ranibizumab (0.3 and 0.5 mg) were compared with those receiving a sham injection (MARINA) or photodynamic therapy (ANCHOR).

The study researchers found that in MARINA, new CNV developed in fellow eyes in 20.3% of the 0.3-mg ranibizumab group by 12 months and in 30.4% by 24 months. The conversion rate in the 0.5-mg ranibizumab group was 21.1% and 38.0% by 12 and 24months, respectively. In the sham group, 26.4% converted by 12 months and 36.3% converted by 24 months. In ANCHOR, fellow eyes in 15.9% of the 0.3-mg ranibizumab group converted by 12 months and fellow eyes in 23.8% converted by 24 months. The researchers reported that the conversion rate in the 0.5-mg ranibizumab group was 24.3% and 35.1% by 12 and 24 months, respectively. In the photodynamic therapy group, 25.4% converted by 12 months and 38.8% converted by 24 months. Furthermore, they noted that differences in conversion rates at 12 and 24 months between the 0.3-mg or 0.5-mg ranibizumab groups and respective controls (sham or photodynamic therapy) were not statistically significant.

According to the researchers, results of this study do not support the hypothesis that monthly ranibizumab injections reduce the rate of CNV development in untreated fellow eyes.

Source: Barbazetto IA, Saroj N, Shapiro H, et al. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol 2010;149(6):939-946.


Two-Year Outcomes of Treating Myopic CNV with Intravitreal Bevacizumab

The aim of this prospective, non-randomized, interventional case series study is to report the changes in best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) in highly myopic subfoveal choroidal neovascularization (CNV) treated by intravitreal bevacizumab at 2 years.

A total of 19 highly myopic eyes from 18 patients with subfoveal and juxtafoveal CNV were treated by three monthly intravitreal injections of 1.25 mg bevacizumab. Patients were evaluated for BCVA and OCT at baseline and then monthly for 2 years.

It was reported that 11 eyes were naïve for treatment and 8 eyes had been previously treated by photodynamic therapy. LogMAR BCVA averaged 0.54 (SD 0.25, range 0.2–1.0; Snellen 20/69) at baseline; 0.40 (SD 0.35, range 0.0–1.0; Snellen 20/59) at 2 years (p=0.04 and p=0.20, respectively, Student's t test paired data). Re-treatment was performed in four eyes during the first year: three eyes at month six and one eye at month 12. Four eyes required one re-injection during the second year at months 14, 18, 20 and 24 and neither ocular nor systemic adverse reactions were detected.

It was determined that intravitreal bevacizumab seems to be effective for subfoveal and juxtafoveal CNV in highly myopic eyes. BCVA gain decreases and is no longer significant by the end of the second year.

Source: Ruiz-Moreno JM, Montero JA. Intravitreal bevacizumab to treat myopic choroidal neovascularization: 2-year outcome. Graefes Arch Clin Exp Ophthalmol 2010;248(7):937-941.


Link Between Percent Disruption of the Photoreceptor Inner Segment-Outer Segment Junction and Visual Acuity in DME

To evaluate the integrity of the photoreceptor inner segment/outer segment (IS/OS) junction using spectral-domain optical coherence tomography (SD OCT) in patients with diabetic macular edema and to correlate the relationship between the integrity of the IS/OS junction and visual acuity, investigators carried out this retrospective, comparative, consecutive case series.

A total of 62 eyes from 38 patients with diabetic macular edema underwent SD OCT imaging. According to the investigators, for each patient, two experienced observers masked to visual acuity measured several SD OCT variables, including central macular thickness, retinal volume, global disruption scale of outer retina, percentage disruption of the outer retina, and history of previous treatments. They used visual acuity recorded as number of Early Treatment Diabetic Retinopathy Study letters as the outcome variable in univariate and multivariate analysis testing the measured SD OCT variables as predictors.

The investigators found a statistically significant correlation between percentage disruption of the IS/OS junction and they also found visual acuity (p=.0312). They also noted a strong trend suggesting a relationship between macular volume and visual acuity, although they found borderline significance (p=.07).

Disruption of the photoreceptor IS/OS junction is an important predictor of visual acuity among diabetic macular edema patients.

Source: Maheshwary AS, Oster SF, Yuson RM, et al. The association between percent disruption of the photoreceptor inner segment-outer segment junction and visual acuity in diabetic macular edema. Am J Ophthalmol 2010;150(1):63-67.


Comparison of IVTA and IVB for Macular Edema Due to BRVO

In Korea, a retrospective comparative case series of 134 consecutive patients who were treated with either intravitreal triamcinolone acetonide (IVTA) injection or intravitreal bevacizumab (IVB) administration for macular edema caused by branch retinal vein occlusion (BRVO) was carried out.

The authors compared visual outcomes after IVTA and IVB administration. They noted visual acuity at baseline and 1, 3, 6, 9 and 12 months, and central macular thickness measured by OCT at baseline and 1, 3, 6 and 12 months. They also analyzed the time to recurrence of macular edema after treatment.

Visual acuity (Snellen equivalent) improved significantly from 0.87 logMAR (0.14) to 0.49 logMAR (0.33) in the IVTA group, and from 0.91 logMAR (0.13) to 0.45 logMAR (0.36) in the IVB group 12 months after injection (p<0.001), the authors observed. They also reported that central macular thickness decreased significantly from 491.0 µm to 255.8 µm in the IVTA group, and from 477.4 µm to 218.9 µm in the IVB group 12 months after injection (p<0.001). In between-group comparisons, neither visual acuity (p=0.892) nor macular thickness (p=0.612) improvements were statistically significantly different and in the IVTA-all group, recurrence of macular edema occurred in 7.6% of patients at a mean of 12.6 months postoperatively, and the average number of injections was 1.08. The study authors also noted that in the IVB-all group, 26.0% of patients suffered recurrences at a mean of 5.3 months after treatment, and received a mean of 1.89 injections and that recurrence was more frequent in the IVB group compared to the IVTA group (Kaplan-Meier survival analysis log-rank test, p<0.0001).

In conclusion, IVTA and IVB injections were similarly effective for improving visual acuity in patients with macular edema secondary to BRVO. However, the IVTA group showed longer mean improvement duration and less disease recurrence, and required fewer injections than the IVB group.

Source: Byun YJ, Roh MI, Lee SC, Koh HJ. Intravitreal triamcinolone acetonide versus bevacizumab therapy for macular edema associated with branch retinal vein occlusion. Graefes Arch Clin Exp Ophthalmol 2010;248(7):963-971.


Experimental Study of Intravitreous Bevacizumab Injection

A group of researchers used this prospective, raondomized, interventional study to determine the effects of intraocular pressure (IOP) and needle diameter on the amount of reflux after intravitreous bevacizumab injection. They found that decreasing the IOP before intravitreous injection and using a smaller-gauge needle reduce the risk of drug reflux after intravitreous bevacizumab injection.

They randomized 12 New Zealand white rabbits weighing approximately 2.5 to 3.5 kg each 1:1 to group 1 or group 2 and used bevacizumab stained with trypan blue for intravitreous injection. To lower the IOP, eyes in group 2 underwent anterior chamber paracentesis before intravitreous injection. The researchers injected two eyes in each group using 27-, 30- or 32-gauge needles and if a subconjunctival bleb formed after intravitreous injection, they measured its diameter using a caliper.

The study researchers reported that the median IOP in group 1 was 17.5 mmHg and that eyes injected using 27-gauge and 30-gauge needles showed stained subconjunctival blebs with median sizes of 3 mm and 1.7 mm, respectively; eyes injected using 32-gauge needles showed no subconjunctival bleb formation. They also noted that the median IOP in group 2 was 10.3 mmHg and that eyes injected using 27-gauge needles showed stained subconjunctival blebs with a median size of 0.7 mm, and eyes injected using 30-gauge and 32-gauge needles showed no subconjunctival bleb formation.

Source: Cortez RT, Ramirez G, Collet L, et al. Intravitreous bevacizumab injection: an experimental study in New Zealand white rabbits. Arch Ophthalmol 2010;128(7):884-887.


Effect of Intravitreal Bevacizumab and PDT for Polypoidal Choroidal Vasculopathy

This Japanese retrospective, comparative, interventional case series compared the efficacy of photodynamic therapy (PDT) with or without intravitreal bevacizumab injection for polypoidal choroidal vasculopathy and found that PDT combined with bevacizumab injection offers significantly better early visual outcomes than PDT alone.

A total of 146 eyes of 146 patients with treatment-naïve polypoidal choroidal vasculopathy including the subfoveal region treated with PDT monotherapy or combined with intravitreal bevacizumab injection were included in this series. Treatments were chosen according to the time period, and for eyes that received combination therapy, bevacizumab (1.25 mg) was administered 1 day before PDT. It was noted that all eyes were followed up for at least 12 months and that ophthalmic evaluations, including measurement of the best-corrected visual acuity (BCVA) and optical coherence tomography, were performed at every visit. Additionally, indocyanine green angiography and fluorescein angiography were performed every 3 months.

It was reported that 61 eyes were treated with PDT combined with bevacizumab and 85 eyes were treated with PDT monotherapy. The mean BCVA was significantly better in the combined treatment group than in the monotherapy group at 3 months (p=.0016), 6 months (p=.028), 9 months (p=.038) and 12 months (p=.048). However, lesions resolved in 78.7% of eyes in the combined group and in 75.3% in the monotherapy group; the recurrence rates were 43.8% and 40.6%, respectively, and did not differ significantly. Moreover, the rate of development of subretinal hemorrhage within 1 month from the initial treatment was significantly lower in the combined group than in the PDT monotherapy group (4.5% vs. 17.7%; p=.023).

In conclusion, combined treatment did not affect the resolution and recurrence of lesions; however, it decreased the rate of development of PDT-related hemorrhages.

Source: Gomi F, Sawa M, Wakabayashi T, et al. Efficacy of intravitreal bevacizumab combined with photodynamic therapy for polypoidal choroidal vasculopathy. Am J Ophthalmol 2010;150(1):48-54.


Influence of Intraocular Vital Dyes on RPE Cells

The authors of this Spanish study evaluated and compared the effects of the following dyes on human pigmented epithelial cells: indocyanine green (ICG), infracyanine green (IfCG), trypan blue (TB), bromophenol blue (BrB), patent blue (PB) and brilliant blue G (BBG).

They exposed in vitro culture of ARPE-19 cells to these dyes and then performed an evaluation of acute and chronic toxicity. They also measured cell viability by colorimetry (MTT assay) and observed cell morphology by phase-contrast microscopy. Additionally, the authors evaluated cell membrane permeability (CMP) by flow cytometry with propidium iodide (PI) and measured mitochondrial membrane potential with 3,3'-dihexyloxacarbocyanine (DiOC6[3]).

According to the authors, each of the studied dyes exhibited toxicity after acute exposure at surgical doses and the presence of light often reduced cell viability, especially when measured 3 h after incubation in the case of ICG, TB, BrB and BBG. They noted that morphological changes were induced by ICG, IfCG and BBG and that both CMP and mitochondrial membrane potential were altered following exposure to surgical doses of ICG, TB, PB and to a four-fold surgical dose of BrB. Moreover, they associated chronic exposure to residual amounts of some dyes with reduced proliferation and even death.

The authors of the study concluded that in order to minimize the risk of toxic effects of each dye, it would appear to be prudent to use the lowest possible dose. This may be particularly important in the case of BrB, which should not be used in excess of 0.5%. They also reported that abundant irrigation of the intravitreal cavity after surgery to completely remove traces of dye may be of crucial importance, particularly in the case of ICG, in minimizing chronic toxicity.

Source: Morales MC, Freire V, Asumendi A, et al. Comparative effects of six intraocular vital dyes on retinal pigment epithelial cells. Invest Ophthalmol Vis Sci 2010;June 16 [Epub ahead of print]. DOI: 10.1167/iovs.09-4916.


Multifocal Electroretinograms and OCT Retinal Thickness in RP Patients

Scientists in the United Kingdom investigated the relationships between retinal morphology and retinal function in patients with retinitis pigmentosa (RP) using optical coherence tomography (OCT) and multifocal electroretinography (mfERG). They found that the relationship between mfERG timing and retinal thickness in RP is dependent on the retinal eccentricity.

In all, 14 patients with RP who had visual acuities of 0.2 logMAR or better and Humphrey central fields of 10° or larger participated in the study, along with 16 normal control subjects. The scientists compared the amplitudes and timings of the mfERG responses with spatially corresponding measures of retinal layer thickness from OCT within the macula region (central 12°).

Eyes with RP showed thinning of the photoreceptor retinal (PR) layer and thickening of mid-inner retinal (MIR) layers beyond the fovea. The scientists noted that mfERG amplitude was reduced in all regions, whereas mfERG timing was only significantly delayed at a retinal eccentricity of 6–12° and was otherwise preserved within the foveal and parafoveal retina (0–6°). Furthermore, they correlated PR layer thickness with mfERG amplitude across the macula region and mfERG timing with the total change in retinal thickness (combined PR thinning and MIR thickening) at an eccentricity of 6–12°.

Preserved timing in the central retina (0–6°), despite significant disruption to retinal laminar structure, could be suggestive of inner retinal remodeling or functional redundancy. The study scientists concluded that cone system activity derived from mfERG amplitude appears to be related to the thickness of the photoreceptor layer in the macula region.

Source: Wolsley CJ, Silvestri G, O'Neill, et al. The association between multifocal electroretinograms and OCT retinal thickness in retinitis pigmentosa patients with good visual acuity. Eye 2010; 23(7):1524-1531.


A 2-Year Look at the Clinical Epidemiology and Socio-Economic Associations of Primary Retinal Detachment in Scotland

Investigators in the United Kingdom established this two-year, prospective, population-based observational study to examine the incidence of primary rhegmatogenous retinal detachment (RRD) in the United Kingdom.

They recruited all cases of primary RRd in Scotland and calculated the annual incidence, then analyzed it in relation to age, gender, refractive error and lens status. They used a national population-based tool, the Scottish Index of Multiple Deprivation (SIMD) to examine the socio-economic distribution of all incident cases.

The investigators identified a total of 1,244 cases during the study period from a population of 5,168,500 yielding an annual incidence of 12.05 per 100,000 population (95% CI=11.35–12.70). They found that the age-specific incidence increased to a peak in both genders in the 60–69 year age group and that RRD was significantly more frequent in males than in females (14.70 vs 8.75 per 100,000; p<0.001). They also noted that 53.2% of cases without previous intraocular surgery were myopic with spherical equivalent refractive error >–1D and that 23.4% of cases had previous cataract surgery and 10.4% were traumatic. The study investigators found a strong association between RRD incidence and affluence, with a highly significant rising trend across quintiles of deprivation.

They determined that the estimated annual incidence of primary RRD in Scotland is 12.05 per 100,000. Based on this estimate, there are approximately 7,300 new cases annual in the United Kingdom. The investigators also determined that RRD incidence increases with age, is more common in men and right eyes and is strongly associated with affluence.

Source: Mitry D, Charteris D, Yorston D, et al. The clinical epidemiology and socio-economic associations of primary retinal detachment in Scotland: a two-year prospective population based study. Invest Ophthalmol Vis Sci 2010;June 16 [Epub ahead of print]. DOI: 10.1167/iovs.10-5400.


A Combination of Phacoemulsification and Sutureless 23-Gauge Vitrectomy for Complex Vitreoretinal Diseases

This retrospective, consecutive interventional case series was conducted to evaluate the safety and visual outcomes of combined phacoemulsification and sutureless 23-gauge vitrectomy for concomitant cataract and vitreoretinal diseases.

A total of 114 eyes of 111 patients underwent combined sutureless 23-gauge vitrectomy and phacoemulsification surgery between January 1, 2006 and March 1, 2009. Visual acuity and perioperative complications were the main outcome measures.

All patients had at least 3 months follow up (mean 263 days) and the main vitreoretinal surgical indications were intractable cystoid macular edema, epiretinal membrane, and retinal detachment. It was noted that mean logMAR visual acuity improved from baseline 20/192 to 20/129 at 3 months (p=0.005). Mean IOP increased from baseline 15.8 mmHg to 17.7 mmHg (p=0.033) on postoperative day 1 and then decreased by postoperative month 3 to 14.8 mmHg (p=0.019). It was reported that 110 (96.5%) eyes had significant pre-existing macular disease, and 93 (81.6%) received preoperative treatments. Additionally, 82 (71.9%) patients required supplemental treatment(s) at a mean of 91.5 days, most commonly intravitreal injections to reduce vascular leakage or YAG capsulotomy. Furthermore, hypotony, defined as IOP <5, was observed in four (3.5%) patients, and no patient developed endophthalmitis. Capsular tears were more frequent in eyes with a history of previous radiation or vitrectomy.

It was concluded that combined phacoemulsification and sutureless 23-gauge vitrectomy surgery was safely and effectively used for cataracts and a variety of complex vitreoretinal diseases.

Source: Sisk RA, Murray TG. Combined phacoemulsification and sutureless 23-gauge pars plana vitrectomy for complex vitreoretinal diseases. Br J Ophthalmol 2010; June 2 [Epub ahead of print]. DOI: 10.1136/bjo.2009.175984.






Lucentis Receives FDA Approval for the Treatment of Macular Edema Following RVO

After a six-month Priority Review, the FDA recently approved Genentech, Inc.'s Lucentis (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO). The BRAVO study assessed the safety and efficacy profile of Lucentis in a total of 397 patients with macular edema following branch RVO and revealed that the percentage of patients in the Lucentis 0.5 mg study arm who gained 15 or more letters in best-corrected visual acuity (BCVA) from baseline at month six was 61% (compared with 29% in the sham injection arm). The CRUISE study assessed the safety and efficacy profile of Lucentis in a total of 392 patients with macular edema following central RVO and found that the percentage of patients in the Lucentis 0.5 mg study arm who gained 15 or more letters in BCVA from baseline at month six was 48% (compared with 17% in the sham injection arm). During the first six-month period, participants in both trials received monthly injections of either 0.3 mg or 0.5 mg of Lucentis (n=527) or monthly sham injections (n=262). The primary endpoint of both studies was mean change from baseline in BCVA at six months compared with patients receiving sham injections. The studies were not designed to compare the two doses of Lucentis. Click here to learn more.

Source: Gententech, Inc. June 2010.




Study Finds Iridex Micropulse Laser Effectively Treats DME

Iridex Corporation recently announced the recent publication of a clinical study comparing results obtained in the treatment of diabetic macular edema (DME) using an Iridex laser and MicroPulse treatment protocol to those obtained using the recognized standar of care Early Treatment of Diabetic Retinopathy Study (ETDRS) laser protocol. At one year, the prospective, randomized study, performed at the University of Padova in Padua, Italy, demonstrated that a MicroPulse protocol was as effective as the ETDRS protocol in the treatment of DME. Iridex also reports that retinal sensitivity improved in eyes in the MicroPulse-treated group and decreased in the ETDRS-treated group, with no detectable signs of laser damage to retinal tissues in eyes in the MicroPulse group while all eyes in the ETDRS group developed localized laser scars.

Source: Iridex Corporation, June 2010.




NDA Submitted to FDA for Iluvien for Treatment of DME

pSivida Corp.'s licensee, Alimera Sciences, has submitted a New Drug Application (NDA) to the FDA for Iluvien, which was developed by pSivida and licensed to Alimera in 2005 for the treatment of diabetic macular edema (DME). (Iluvien is a sustained release drug delivery system releasing the steroid flucocinolone acetonide.) Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of this year. The NDA submission includes the 24-month low dose data from two pivotal phase three clinical trials (collectively known as the FAME Study), which involve 956 patients in sites across the United States, Canada, Europe and India. Alimera has indicated that it plans to follow this NDA submission with registration filings in certain European countries and Canada in the near future. pSivida has joint ownership and reference rights to this NDA.

Source: pSivida Corp., June 2010.


Novel Protein for AMD Discovered

InNexus Biotechnology Inc. has revealed that it has developed IXS312 (Vascular Endothelial Growth Factor [VEGF]), an antibody fragment with activity against the growth factor VEGF for planned use in ocular treatments. According to company executives, IXS312 is a small protein fragment intended for use as a topical therapy for AMD and diabetic retinal dysplasia. InNexus's protein research team developed IXS312 to treat ocular diseases without the need for invasive application steps such as direct injection into the eye.

Source: InNexus Biotechnology Inc., June 2010.


 

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