From the editors of Review of Ophthalmology:
JANUARY IS GLAUCOMA AWARENESS MONTH
In this issue: (click heading to view article)
Real-world Outcomes Following 12 Months of Intravitreal Aflibercept Monotherapy in DME: APOLLON Study
Researchers reported the effectiveness of intravitreal aflibercept (IVT-AFL) treatment for diabetic macular edema in French clinical practice, as part of APOLLON, a prospective, observational cohort study of individuals with DME.
Effectiveness was evaluated by change from baseline in best-corrected visual acuity at 12 months in treatment-naïve patients (i.e., hadn’t received any anti-vascular endothelial growth factor agent, laser or steroid at IVT-AFL treatment start) and previously-treated patients (i.e., previously treated with anti-VEGF agents other than IVT-AFL, laser or steroids at IVT-AFL treatment start). Secondary endpoints included change in central retinal thickness over 12 months, frequency of injections and proportion of patients with safety events. Here were some of the findings:
• Of the 147 individuals followed for at least 12 months and included in the effectiveness analysis, 52.4 percent (n=77) were treatment-naïve and 47.6 percent (n=70) were previously treated.
• Mean (standard deviation) BCVA score at baseline was 62.7 (14.3) Early Treatment Diabetic Retinopathy Study letters in treatment-naïve individuals and 60 (13.7) ETDRS letters in previously-treated patients.
• At month 12, mean (SD) change in BCVA was + 7.8 (12.3) letters in treatment-naïve individuals and +5 (11.3) letters in previously-treated patients.
• Mean CRT decreased in both cohorts.
• The mean (SD) number of IVT-AFL injections at month 12 was 7.6 (2.5) for treatment-naïve individuals and 7.6 (2.3) for previously-treated individuals. Of 388 people included in the safety analysis, ocular treatment-emergent adverse events occurred in 54.1 percent (n=210) of individuals.
Researchers determined that IVT-AFL treatment was associated with improvements in functional and anatomic outcomes in treatment-naïve and previously-treated patients with DME in France.
Source: Korobelnik JF, Daien V, Faure C, et al. Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: Results from the APOLLON study. Ophthalmology 202; Jan 2. [Epub ahead of print].
Novel Surgical Technique for Ahmed Glaucoma Valve Implantation Without Plate Sutures
Investigators assessed the safety and efficacy of a modified Ahmed glaucoma valve implantation technique without plate sutures, as part of a retrospective, case-control study including individuals seen in the glaucoma service of an academic institution.
Individuals who underwent a modified AGV implantation without plate sutures were included as cases, and individuals who underwent standard AGV implantation were controls. Success was defined as an intraocular pressure reduction greater than 20 percent, an IOP >5 and <21 mmHg without need for additional surgical intervention and maintenance of light perception.
A total of 170 eyes were included. Mean follow-up was 11.2 ±7.39 months (range: three to 24). Here were some of the findings:
• No statistically significant difference was found in visual acuity and IOP between the groups during the postoperative period.
• In a univariate analysis, a larger decrease was found in IOP for the no-plate-suture group at the six-month (-15.6 ±11.6 vs. -11.5 ±10.5 mmHg, p=0.04) and one-year (-16.4 ±10.4 vs. -11.1 ±10.4 mmHg, p=0.02) visits.
• A larger decrease was found in the number of medications in the no-plate-suture group in the three-month (-1.65 ±1.5 medications vs. -1.13 ±1.22, p=0.02), six-month (-1.55 ±1.44 vs. -0.98 ±1.3, p=0.01) and one-year (-1.70 ±1.5 vs. -1.04 ±1.2, p=0.04) visits. However, the differences weren’t confirmed by a multivariable model after adjusting for glaucoma type and number of previous glaucoma surgeries.
• No differences in the trajectory of survival curves were noted between groups (p=0.36).
Investigators reported that the short- and mid-term outcomes of patients undergoing AGV implantation using both techniques showed similar outcomes and success rates.
SOURCE: Sanvicente CT, Moster MR, Lee D, et al. A novel surgical technique for Ahmed glaucoma valve implantation without plate sutures. J Glaucoma 2019; Dec 24. [Epub ahead of print].
Patching Retinal Breaks with Healaflow in 27-Gauge Vitrectomy for RRD
Scientists reported the surgical outcomes of primary rhegmatogenous retinal detachment repaired by 27-gauge pars plana vitrectomy combined with Healaflow patch and air tamponade. According to its maker, Simovision, Healaflow is a slowly resorbable viscoelastic implant indicated for penetrating and non-penetrating glaucoma surgery.
In an initial in vitro
experiment, they observed and compared the dissolution and displacement of the dispersion spots of 0.05-mL Healaflow and sodium hyaluronate. They then performed a prospective, interventional cohort study on 38 eyes in 37 consecutive individuals with primary RRD. All eyes underwent PPV combined with Healaflow patch and air tamponade; the postoperative period didn’t involve prone positioning. Scientists evaluated primary and final anatomical attachment rate, best-corrected visual acuity, and intraoperative and postoperative complications. Here were some of the findings:
• In the in vitro
experiment, the viscoelastic Healaflow remained adherent, with no change in the size of the area; however, the control dissolved completely in the balanced salt solution.
• The study included 16 women (43.2 percent) and 21 men (56.8 percent) (mean age, 59.5 ±9.5 years; mean follow-up period, 8.9 ±3.8 months).
• A single break was present in 21 (55.3 percent) cases, and two to five breaks were present in 17 cases (44.8 percent).
• The macula was involved in 25 (65.8 percent) cases and attached in 13 cases (34.2 percent) intraoperatively.
• Initial reattachment was achieved in 37 (97.4 percent) cases and final reattachment was achieved in 38 cases (100 percent).
• In one case (2.6 percent), the macula re-detached because of failure of the chorioretinal scar to develop around the treated break.
• Mean preoperative BCVAs were 1.02 ±0.82 logMAR (median Snellen acuity: 20/125, range: 20/20,000 to 20/20), and mean postoperative BCVAs were 0.23 ±0.17 logMAR (median Snellen acuity: 20/32, range: 20/100 to 20/20)(p
• Intraocular pressure was elevated transiently in 28 eyes (73.7 percent).
• No other intraoperative complications or postoperative scleral incision leakage were found.
Scientists wrote that a 27-gauge pars plana vitrectomy combined with Healaflow patch and air tamponade resulted in a high reattachment rate in the treatment of RRD. As such, they added, this strategy potentially may offer patients early visual recovery and less complications.
SOURCE: Ren XJ, Bu SC, Wu D, et al. Patching retinal breaks with Healaflow in 27-gauge vitrectomy for the treatment of rhegmatogenous retinal detachment. Retina 2019; Dec 18. [Epub ahead of print].
Low-concentration Atropine for Myopia Progression (LAMP) Study
Researchers assessed the efficacy and safety of 0.05%, 0.025% and 0.01% atropine eye drops over two years to determine the optimal concentration for longer-term myopia control.
The randomized, double-masked trial, extended from the Low-Concentration Atropine for Myopia Progression (LAMP) study, included 383 (87 percent) of 438 children, ages four to 12 years, with myopia of at least -1 D originally randomized to receive atropine 0.05%, 0.025%, 0.01% or placebo once daily in both eyes.
Children from the placebo group in Phase I were switched to receive 0.05% atropine from the beginning of the second year follow-up, while those in the 0.05%, 0.025% and 0.01% atropine groups continued with the same regimen. Cycloplegic refraction, axial length (AL), accommodative amplitude, photopic and mesopic pupil diameter, and best-corrected visual acuity were measured at four-month intervals.
Main outcome measures were changes in spherical equivalent (SE) and AL, and their differences between groups. Here were some of the findings:
• Over the two-year period, the mean SE progression was 0.55 ±0.86 D in the 0.05% atropine group (p
=0.015); 0.85 ±0.73 D in the 0.025% atropine group (p
<0.001); and 1.12 ±0.85 D in the 0.01% atropine group (p
=0.02); with mean AL changes over two years of 0.39 ±0.35 mm (p
=0.04), 0.50 ±0.33 mm (p
<0.001) and 0.59 ±0.38 mm (p
• Compared with the first year, the second year efficacy of 0.05% and 0.025% remained similar (p
=0.45 and p
=0.31), but mildly improved in the 0.01% atropine group (p
• For the Phase I placebo group, myopia progression was significantly reduced after switching to 0.05% atropine (SE change, 0.18 D in the second year vs. 0.82 D in the first year, p
<0.001; AL elongated 0.15 mm in the second year vs. 0.43 mm in the first year, p
• Accommodation loss and change in pupil size in all concentrations remained similar to the first-year results, and were well-tolerated.
• Visual acuity and vision-related quality of life remained unaffected.
Researchers found that, over two years, the observed efficacy of 0.05% atropine was double that achieved with 0.01% atropine, and it remained the optimal concentration among the studied atropine concentrations in slowing myopia progression.
SOURCE: Yam J, Li FF, Zhang X, et al. Two-year clinical trial of the low-concentration atropine for myopia progression (LAMP) study: Phase 2 report. Ophthalmology 2019; Dec 20. [Epub ahead of print].
B+L Expands Parameters for Biotrue OneDay for Astigmatism CLs
Bausch + Lomb recently announced the U.S. launch of expanded parameters for Biotrue OneDay for Astigmatism daily disposable contact lenses. The expansion will increase the toric parameter range by more than 60 percent, the company says. Similar to the other products in the Biotrue OneDay brand family, Biotrue OneDay for Astigmatism lenses are formulated with a patented dehydration barrier, which B+L says helps the lens maintain nearly 100 percent of its moisture for a full 16 hours. An evolved peri-ballast design features a tapered edge to limit lid interaction, and spherical aberration control to help reduce halos and glare, particularly in low-light conditions. View the expanded parameters.
DORC Announces FDA Approval of TissueBlue Orphan NDA
The Dutch Ophthalmic Research Center received FDA approval of its New Drug Application for TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025%. TissueBlue is the first FDA-approved dye for use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane. The stain is injected onto the inner retinal surface for clear staining of the ILM as a way to distinguish it from unstained retina during its removal. Additional highlights include:
• its use with more than 350,000 surgical procedures since launch;
• a unique U.S. formulation featuring pharmaceutical-grade dye material to ensure a higher level of purity than lower-grade (compounded) dyes;
• the inclusion of polyethylene glycol to provide the density required by surgeons to ensure targeted application to the retina; and
• availability in a terminally sterilized, prefilled syringe.
DORC says it expects to start shipping TissueBlue to customers in early April.
Lineage Reports Additional Positive Findings in OpRegen Study
Lineage Cell Therapeutics says that additional data from its ongoing Phase I/IIa clinical study of OpRegen has been positive. OpRegen is the company’s retinal pigment epithelium transplant therapy for the treatment of dry age-related macular degeneration. The first cohort of four patients treated using a new subretinal delivery system and the company’s new thaw-and-inject formulation has continued to demonstrate notable improvements in vision Lineage says, with gains of 25 readable letters (or five lines) after six months, as assessed by the Early Treatment Diabetic Retinopathy Scale. Read more.
AsclepiX Appoints Theresa Heah, MD, as CMO
AsclepiX Therapeutics appointed Theresa G. H. Heah, MD, MBA, as its chief medical officer. Dr. Heah previously served as chief medical officer at Applied Genetic Technologies Corp., where she worked on developing ophthalmic gene therapies. Before that, she was vice president, global head of clinical research, medical and professional affairs at Aerie Pharmaceuticals. Read more.
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