From the editors of Review of Ophthalmology:
Monday, November 18, 2019
November is Diabetic Eye Disease Awareness Month
In this issue: (click heading to view article)
Outcomes in DME Patients Requiring Cataract Surgery in VISTA & VIVID
Researchers evaluated the impact of cataract surgery on visual and anatomic outcomes in patients with diabetic macular edema treated with intravitreal aflibercept injection (IAI) or laser (used as a control) who didn’t require rescue therapy, as part of a post hoc analysis of two Phase III trials: VISTA and VIVID.
Participants included 54 (laser, n=11; IAI, n=43) patients who underwent cataract surgery during the study period.
In VISTA and VIVID, patients received IAI 2 mg for q4 weeks, IAI 2 mg for q8 weeks following five monthly doses or laser control through week 100. Starting at week 24, if rescue treatment criteria were met, IAI patients received laser, and laser patients received IAI 2q8 (following five monthly doses). Patients who received rescue treatment before cataract surgery were excluded.
Main outcome measures were best-corrected visual acuity and central retinal thickness in the laser and pooled IAI groups before and after cataract surgery. Here were some of the findings:
• The cumulative incidence of cataract surgery didn’t depend on treatment group assignment (rate ratio [CI]=1.517 [0.782, 2.944]; p=
• At the last study visit before surgery: in the laser control group, BCVA was 62.2 and CRT was 342 μm; in the IAI group, BCVA was 56.9 letters and CRT was 301 μm.
• At the first study visit post-cataract surgery, BCVA was significantly improved in the laser control group to 73.5 letters (p=
0.010 compared with last visit before surgery) and in the IAI group to 67.2 letters (p<
0.001 compared with last visit before surgery).
• The corresponding change in CRT was a modest increase in the laser control group to 364 μm (p>
0.05 compared with last visit before surgery) and in the IAI group to 359 μm (p=
0.013 compared with last visit before surgery).
Researchers found that the incidence of cataract surgery was similar in both treatment groups. They wrote that, despite a modest worsening in CRT after cataract surgery, BCVA was improved in both treatment groups.
Source: Moshfeghi AA, Thompson D, Berliner AJ, MD, et al. Outcomes in patients with diabetic macular edema requiring cataract surgery in VISTA and VIVID studies. Ophthalmology 2019; Nov. 4. [Epub ahead of print].
Differences in ECL Between Endothelium-in vs. Endothelium-out Loading in DMEK
Investigators compared endothelial cell loss between donor grafts loaded in the Geuder Glass Cannula and the Coronet EndoGlide made for Descemet’s membrane endothelial keratoplasty.
They obtained prestripped tissues using the submerged cornea using the backgrounds away (SCUBA) technique from an eye bank. And they loaded donor grafts with the Geuder or Coronet. Investigators then ejected grafts directly onto a glass slide, stained and imaged with confocal fluorescent microscopy, and used trainable Fiji (ImageJ) segmentation software to quantify endothelial cell loss.
A total of 23 total tissue samples were tested. Eleven grafts were loaded using the Geuder, and 12 were loaded with the Coronet. Here were some of the findings:
• Preloading graft endothelial cell density was comparable between Geuder (2,436 ±581 cells/mm2) and Coronet (2,577 ±483 cells/mm2) groups, p=0.56.
• Other baseline characteristics including donor age (p=0.73) and time from death to loading (p=0.66) were comparable.
• Average ECL—11.3 ±3 percent in the Geuder group vs. 7.2 ±7 percent in the Coronet group—wasn’t significantly different (p=0.07).
• When observing patterns of cell loss, grafts loaded in the Coronet DMEK EndoGlide resulted in more focal forceps grabs and trifold patterns.
• Grafts loaded with the Geuder Glass Cannula yielded more diffuse stippled stress lines.
The results suggested comparable ECL between Geuder (endothelium-out) and Coronet (endothelium-in) DMEK EndoGlide tissue injection techniques. Investigators concluded that patterns of endothelial cell loss in the Coronet group correlated with forceps grabs, but suggested that additional manipulation of tissue didn’t result in higher endothelial cell loss.
SOURCE: Ho J, Jung H, Banitt M. Quantitative and qualitative differences in endothelial cell loss between endothelium-in versus endothelium-out loading in Descemet Membrane Endothelial Keratoplasty. Cornea 2019; Oct 30. [Epub ahead of print].
Using SS-OCT to Assess Changes Following Panretinal Photocoagulation
Scientists assessed the effect of panretinal photocoagulation on choroidal vascular parameters in eyes with advanced diabetic retinopathy.
Forty patients (65 eyes) with severe nonproliferative DR or proliferative DR who underwent PRP were included. They evaluated changes in choroidal vascular parameters at three, six and 12 months after PRP by using swept-source optical coherence tomography, and compared OCT angiography with baseline values.
Here were some of the findings:
• The choroidal vascularity index significantly decreased from 66.27 ±1.55 percent at baseline to 65.85 ±1.61 percent at three months, 65.77 ±1.29 percent at six months and 65.74 ±1.60 percent at 12 months after PRP.
• The ratio of luminal to stromal area (L/S ratio) also significantly decreased from 1.98 ±0.15 at baseline to 1.94 ±0.14 at three months, 1.95 ±0.13 at six months and 1.93 ±0.14 at 12 months after PRP.
• The subfoveal choroidal thickness similarly showed a significant decrease from 319.50 ±56.64 μm at baseline to 299.07 ±51.14 μm at three months, 294.70 ±58.96 μm at six months and 280.93 ±53.57 μm at 12 months after PRP.
• The choriocapillaris vessel density in both the fovea and parafovea showed no significant differences following PRP.
Scientists concluded that eyes with advanced DR showed a significant reduction in CVI, L/S ratio and SFCT over 12 months after PRP treatment.
SOURCE: Kim JT, Park N. Changes in choroidal vascular parameters following pan-retinal photocoagulation using swept-source optical coherence tomography. Graefes Arch Clin Exp Ophthalmol 2019; Nov 3. [Epub ahead of print].
Phacoemulsification vs. Phacotrabeculectomy in POAG With Cataract
Researchers aimed to compare long-term clinical outcomes of phacoemulsification vs. phacotrabeculectomy in primary angle-closure glaucoma eyes with cataract.
Two initial prospective, randomized controlled trials recruited PACG eyes with cataract using the same criteria and randomized these eyes to undergo either phacoemulsification or phacotrabeculectomy. The researchers pooled up to five years’ worth of clinical follow-up data for retrospective analysis.
The clinical data of 35 patients in the phacoemulsification group and 44 patients in the phacotrabeculectomy group were analyzed. Here were some of the findings:
• At five years after surgery, the mean IOP was decreased by 20.7 percent after phacoemulsification, and by 29.5 percent after phacotrabeculectomy, (p<
0.001 for both groups).
• Phacotrabeculectomy was significantly more effective than phacoemulsification in reducing IOP up to five years after surgery (p<
• At five years, the mean number of glaucoma drugs required was 1.6 ±1.2 in the phacoemulsification group and 0.7 ±1 in the phacotrabeculectomy group (p=
• Phacotrabeculectomy was associated with more postoperative complications than phacoemulsification up to five years postop (25 complications in the phacotrabeculectomy group vs. six in the phacoemulsification group; p<
Researchers determined that phacoemulsification alone reduced IOP and the need for glaucoma drugs in PACG eyes with cataracts for up to five years postop. They found that phacotrabeculectomy was more effective in reducing IOP and glaucoma drugs than phacoemulsification alone but was associated with more postoperative complications up to five years after surgery.
SOURCE: Hansapinyo L, Choy B, Lai J, et al. Phacoemulsification versus phacotrabeculectomy in primary angle-closure glaucoma with cataract. J Glaucoma 2019; Nov. 6. [Epub ahead of print].
Biogen to Expand Biosimilars Portfolio Through Samsung Bioepis Transaction
Biogen announced a new proposed transaction with Samsung Bioepis to secure the exclusive rights to commercialize two new ophthalmology biosimilars, SB11 referencing Lucentis and SB15 referencing Eylea, in major markets worldwide, including the United States. In addition, Biogen will acquire exclusive commercialization rights for its anti-TNF portfolio. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s approved biological product, with the purported advantage that they offer cost savings and promote “sustainable access to therapies,” Biogen says. Read more.
Grant Awarded to Eversight
Eversight, a non-profit organization that recovers and provides human eye tissue for transplantation, supports vision research, promotes donation awareness, and provides humanitarian aid to patients in need of corneal transplantation, recently received a a $50,000 grant from the Eye Bank Association of America. The grant is earmarked for Eversight and its research partners to investigate cell expansion aiming to mitigate the global shortage of surgical-quality donor corneas available for transplantation. To that end, the Eversight Center for Vision and Eye Banking Research in Cleveland has partnered with the University of Melbourne and the Centre for Eye Research Australia to investigate viability of engineering corneal grafts for use as an alternative to human donor corneal tissue. Read more.
Katena Announces Acquisition of Micro Medical Instruments
Katena has acquired Micro Medical Instruments. Founded in 1990, MMI offers an FDA-registered contract manufacturing service to the medical device industry, and its product focus is ophthalmic microsurgical instruments, the company says. Katena says the acquisition will give it “greater control over our manufacturing while continuing to provide exceptional quality instruments in the ophthalmic space.”
Ocular Therapeutix Announces Operational Restructuring
Ocular Therapeutix announced an operational restructuring plan which, upon completion, is expected to result in an estimated $11 million in annualized savings through personnel reductions and approximately $14 million in one-time program deferrals. Ocular Therapeutix says that the restructuring represents a strategic realignment and commitment to allocate capital and resources to maximize the commercial opportunity of Dextenza and focus resources on progressing the company’s Dextenza Phase III trial in allergic conjunctivitis, Phase I trials of OTX-TIC for the treatment of glaucoma and ocular hypertension, and OTX-TKI for the treatment of wet age-related macular degeneration. Read more.
Novaliq & Jiangsu Hengrui Medicine Collaborate
Novaliq and Jiangsu Hengrui Medicine closed an exclusive license agreement to develop, manufacture and commercialize the innovative, water-free drugs NOV03 and CyclASol for the treatment of dry-eye disease in the People’s Republic of China (including Hong Kong, Macau and Taiwan). The company says both investigational drugs have shown in their recent late-stage clinical trials superior efficacy, with an early onset of action and an “excellent” tolerability profile. Read more.
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