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Volume 16, Number 20
Monday, May 16, 2016
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MAY IS WOMEN’S EYE HEALTH AND SAFETY AWARENESS MONTH



In this issue: (click heading to view article)
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######### Choroidal Thickness Shifts After Intravitreal Bevacizumab for nAMD & DME
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######### SF6 vs. Perfluoropropane Tamponade for Macular Hole Repair
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######### BAK-free Latanoprost Ophthalmic Solution on Ocular Surface in Glaucoma
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######### Six-Month IOP Reduction with a Topical Bimatoprost Ocular Insert
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  Briefly

 



Choroidal Thickness Shifts After Intravitreal Bevacizumab for nAMD & DME

Researchers analyzed changes in subfoveal choroidal thickness (SFCT) after intravitreal injection of bevacizumab for neovascular age-related macular degeneration and diabetic macular edema, as part of a retrospective, consecutive, interventional case series study.

The study included 43 eyes (21 affected eyes with neovascular AMD [AMD group] and 22 affected eyes with DME [DME group]) treated with 1.25 mg/0.5 ml IVB and 43 untreated fellow eyes of 43 individuals.

SFCT was measured in all 86 eyes at baseline before IVB injection and at day one, week one and month one after injection by use of enhanced-depth imaging optical coherence tomography. Central foveal thickness and best-corrected visual acuity were analyzed at baseline and during follow-up visits. The main outcome measure was change in SFCT in one month after treatment.

All 43 eyes treated with IVB showed a significant reduction in SFCT. Mean SFCT in treated eyes decreased from 237.1 ±75.3 µm at baseline to 214.0 ±65.7 µm at day one; 205.4 ±59.7 at week one; and 222.7 ±73.3 at month one, whereas SFCT in fellow eyes changed from 228.4 ±63.6 at baseline to 224.5 ±68.5 at day one; 220.4 ±72.1 at week one; and 226.9 ±74.0 at month one. SFCT demonstrated a trend toward decrease in both groups. CFT decreased significantly and visual acuity improved significantly.

Researchers found that SFCT decreased significantly in AMD and DME eyes following injection. The decreasing effect of bevacizumab on choroidal thickness was highest at first week and continued to the end of first month after injection.

SOURCE: Ünlü C, Erdogan G, Gunay BO, et al. Subfoveal choroidal thickness changes after intravitreal bevacizumab injection for neovascular age-related macular degeneration and diabetic macular edema. Int Ophthalmol. 2016 May 6. [Epub ahead of print].



SF6 vs. Perfluoropropane Tamponade for Macular Hole Repair

Investigators compared early visual and anatomical outcomes after sulfur hexafluoride (SF6) or perfluoropropane (C3F8) tamponade for macular hole repair.

A total of 147 eyes affected by primary full-thickness macular hole underwent pars plana vitrectomy with dye-assisted removal of the internal limiting membrane and gas tamponade. Prone position was prescribed for 48 hours after surgery. All individuals were divided into three groups depending on the size of the hole: small (<250 µm), medium (>250–<400 µm) or large (>400 µm). Eyes within the same group randomly received either SF6 (70 eyes) or C3F8 (77 eyes). A complete ophthalmic evaluation, including best-corrected visual acuity and anatomic status of the macular holes, was conducted preoperatively, at one week and one month after surgery. Macular hole volume was calculated using optical coherence tomography scans. The Wilcoxon Signed Ranks Test, the Mann-Whitney Test, the Spearman’s rank-order correlation coefficient and the study of variance for repeated measures were used for statistical analysis.

Mean best-corrected visual acuity improved from 0.92 logMAR to 0.28 logMAR (p<0.001). A reduction of the dimensions of macular holes was observed in all cases, with a total repair of 90 percent (63/70 eyes) in the SF6 group and 91 percent in the C3F8 group (70/77 eyes). There was a negative correlation between the initial minor diameter, the volume of the hole and the rate of anatomic success.

Investigators determined that short-term anatomical and visual outcomes were similar in eyes treated with either SF6 or C3F8, independent of the stage of the macular hole. They offered that initial volume and the minor diameter of the hole may be considered as valid tools for predicting surgical success, adding that age and gender did not appear to influence the prognosis.

SOURCE: Casini G, Loiudice P, De Cillà S, et al. Sulfur hexafluoride (SF6) versus perfluoropropane (C3F8) tamponade and short term face-down position for macular hole repair: a randomized prospective study. nternational Journal of Retina and Vitreous. 2016; Apr 1. [Epub ahead of print].


BAK-free Latanoprost Ophthalmic Solution on Ocular Surface in Glaucoma

Scientists evaluated the efficacy and safety of BAK-free latanoprost, as part of a prospective, open-label, single-arm, multicenter, eight-week study in individuals with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months.

Individuals were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs.

At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67 ±1.60 seconds) to 5.03 ±2.64 and 6.06 ±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (p<0.0001). Ocular Surface Disease Index score also decreased significantly to 12.06 ±13.40 at 28 days and 7.06 ±10.75 at 56 days vs. baseline (18.09 ±18.61, p<0.0001). In addition, inferior corneal staining score decreased significantly to 0.53 from baseline (0.85, p=0.0033). A reduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08 percent) treatment-emergent AEs occurred in seven people, with eye pain and irritation being the most frequent. No clinically significant changes in vital signs or slit-lamp examinations were observed.

Results indicated that switching from BAK-containing latanoprost to BAK-free latanoprost resulted in significant improvements in TBUT; OSDI score; inferior corneal staining score; and measurable reductions in conjunctival hyperemia score. Furthermore, BAK-free latanoprost was well-tolerated, with only mild-to-moderate and self-limiting AEs.

Scientists concluded that BAK-free latanoprost appeared to be effective in protecting ocular surface integrity in individuals with glaucoma, but suggested that further studies are needed to confirm this beneficial effect.


SOURCE: Walimbe T, Chelerkar V, Bhagat P, et al. Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma. Clin Ophthalmol. 2016;10: 821-7.

 

Six-Month IOP Reduction with a Topical Bimatoprost Ocular Insert

Researchers compared a topical bimatoprost ocular insert with twice-daily timolol eye drops in individuals with open-angle glaucoma or ocular hypertension treated for six months, as part of a parallel-arm, multicenter, double-masked, randomized, controlled trial.

A total of 130 adults with OAG or OHT participated. Eligible participants were randomized 1:1 to receive a bimatoprost insert plus artificial tears twice daily, or a placebo insert plus timolol (0.5% solution) twice daily for six months after a screening washout period. Diurnal IOP measurements (at zero, two and eight hours) were obtained at baseline; and weeks two, six and 12; and months four, five and six. Key eligibility included washout IOP of 23 mmHg or more at time zero; IOP of 20 mmHg or more at two and eight hours; IOP of 34 mmHg or less at all time points; no prior incisional surgery for OAG or OHT; and no known nonresponders to prostaglandins.

The primary efficacy end point examined the difference in mean change from baseline in diurnal IOPs (point estimate, 95 percent confidence interval) across nine coprimary end points at weeks two, six and 12, comparing the bimatoprost arm with the timolol arm, using a noninferiority margin of 1.5 mmHg. Secondary end points were diurnal IOP measurements at months four, five and six, and adverse events (AEs).

A mean reduction from baseline IOP of −3.2 mmHg to −6.4 mmHg was observed for the bimatoprost group compared with −4.2 mmHg to −6.4 mmHg for the timolol group over six months. The study met the noninferiority definition at two of nine time points but was underpowered for the observed treatment effect. Adverse events were consistent with bimatoprost or timolol exposure; no unexpected ocular AEs were observed. Primary retention rate of the insert was 88.5 percent of individuals at six months.

Researchers observed a clinically relevant reduction in mean IOP over six months with a bimatoprost ocular insert, suggesting the insert seemed to be safe and well-tolerated. They found that the topically applied device may provide an alternative to daily eye drops to improve adherence, consistency of delivery and reduction of elevated IOP.

SOURCE: Brandt JD, Sall K, DuBiner H, et al. Six-Month Intraocular Pressure Reduction with a Topical Bimatoprost Ocular Insert. Ophthalmology. 2016 May 5. [Epub ahead of print].

 

 




  • Encore Releases Positive Phase I/II Study Results of Topical EV06
    Encore Vision presented positive results during the Ophthalmic Innovation Summit from its Phase I/II study evaluating the safety and efficacy of EV06 ophthalmic solution 1.5%. EV06 is a novel topical therapy that targets presbyopia by restoring crystalline lens flexibility, thereby allowing the lens to focus on nearby objects. After three months of twice-daily treatment with one drop of EV06 (n=50) or placebo (n=25), subjects in the EV06 group demonstrated improvement in all distance-corrected, near-vision acuity (DCNVA) efficacy measures. By day 91, 82 percent had 20/40 DCNVA or better in the EV06 group compared to 48 percent in placebo, with baseline values of 30 percent and 28 percent, respectively. Similarly, 60 percent of EV06‐treated subjects had 20/32 DCNVA or better at day 91 compared to only 24 percent in placebo; the baseline value for this measure in both groups was 8 percent. Read more.


  • Abbott Announces Positive Results from Tecnis Symfony IOL Study
    Abbott announced that its clinical trial of the company’s Tecnis Symfony 1-Piece Acrylic intraocular lens met its primary endpoint of improved intermediate vision. Data from this study showed that people who received the Tecnis Symfony lens achieved significantly improved intermediate, as well as near, vision compared to those who received a monofocal IOL. Unlike monofocal IOLs that provide a fixed focus point at one particular distance, the lens has proprietary optical features designed to elongate the range of focus of the eye and provide a continuous range of vision at near, intermediate and distance. The Symfony IOL has been widely studied, with data from more than seven studies in more than 2,000 eyes being collected. It is approved in more than 50 countries around the world. In the United States, it is an investigational lens and is not available for commercial use. Read more.


  • Tri-Moxi-Vanc Dropless Therapy Shows Statistically Significant Drop in CME
    Imprimis Pharmaceuticals announced the positive results of an investigator-initiated clinical study presented at the American Society of Cataract and Refractive Surgery Congress in New Orleans, relating to the company’s triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (Tri-Moxi-Vanc) dropless therapy formulation. The purpose of the study was to prospectively compare rates of postoperative CME using traditional steroid and NSAID drops with dropless therapy (intravitreal Tri-Moxi-Vanc) combined with an NSAID drop. A total of 1,200 consecutive cataract surgeries were monitored for CME prospectively for 90 days postop, excluding cases with preoperative CME. The results of the study revealed the CME rate was 1.5 percent in the historical group (n= 600) using NSAID and steroid drops postoperatively. The CME rate was 0.5 percent in the group (n=600) receiving dropless therapy (intravitreal Tri-Moxi-Vanc) with postoperative NSAID drops only, thereby achieving statistical significance (p=0.003) in CME prevention vs. traditional steroid and NSAID drops. Read more.


  • Acucela Initiates Phase II Clinical Trial Addressing PDR
    Acucela announced the company initiated a Phase II clinical trial with the successful enrollment of the first patient, to assess the benefits of emixustat hydrochloride for the treatment of proliferative diabetic retinopathy. Acucela has submitted a clinical study protocol to the U.S. Food and Drug Administration and has received Institutional Review Board approval to initiate a randomized, placebo-controlled, Phase II clinical trial evaluating emixustat in patients with PDR. In this three-month study, 20 individuals will be dosed once daily with oral emixustat. Pre-specified study endpoints include changes in cytokine expression levels associated with PDR severity and changes in ocular neovascularization. With the enrollment of the first patient, the Phase II clinical trial is under way. Read more.




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