EW Weekly, May 22, 2020

Phase 2 results from SKYGGN study for inflammation and pain after cataract surgery
Oculis reported positive results from its Phase 2 SKYGGN study of OCS-01 (topical dexamethasone ophthalmic suspension, 1.5%). The drop, according to the company, uses a proprietary nanoparticle technology to increase solubility and time that the drug is active on the ocular surface. The study was multicenter, randomized, double masked, and vehicle controlled. The drop was found to be well tolerated and safe compared to the control, and Oculis reported a significantly higher percentage of eyes with no inflammation in the OCS-01 once-a-day group compared to the vehicle (51% compared to 19.6%, respectively). The company also reported a higher percentage of eyes with a pain score of zero in the OCS-01 group (72.5% compared to 54.9% vehicle).

Phase 3 results for ranibizumab biosimilar candidate
The ranibizumab biosimilar candidate, SB11 by Samsung Bioepis, met primary endpoints in its randomized, double-masked, Phase 3 trial for wet AMD. According to the company, the least squares mean change in BCVA at week 8 in the SB11 group was 6.2 letters, compared to 7.0 letters in the reference ranibizumab group. Least squares mean change in central subfield thickness at week 4 in the SB11 group was –108.4 μm for SB11 vs. –100.1 μm in the reference group. Incidence of adverse events was similar between the two groups (66.0% SB11 vs. 66.9% reference ranibizumab).

TECNIS Multifocal Toric II launched
Johnson & Johnson Vision announced the launch of the first multifocal IOL with astigmatism correction on its Toric II platform. The TECNIS Multifocal Toric II IOL has frosted haptics intended to increase friction between the haptic and capsular bag, increasing stability of the IOL. In the initial launch, available cylinder powers for the lens include 1.50, 2.25, 3.00 and 3.75 on the 3.25 D and 2.75 D multifocal add power designs. According to the news release from the company, two post-market clinical trials are underway to confirm rotational stability and visual outcomes of the TECNIS Toric II platform.

BVI acquires new OVD portfolio
Beaver-Visitec International (BVI) announced the acquisition of a new ophthalmic viscoelastic device portfolio from Croma-Pharma and, in doing so, announced its launch of the new cohesive hyaluronic acid OVD NuVisc Pro in Europe. According to the company, this new OVD has demonstrated safety and efficacy in a clinical study completed in December 2019. It can be used in all stages of cataract surgery, the press release stated. BVI stated that it will continue to collaborate with Croma on research and development for additional products going forward.

ASCRS and IJCAHPO Technicians & Nurses Program virtual broadcast
Technicians and nurses are encouraged to join a virtual broadcast series of topics from the 2020 Technicians & Nurses Program sponsored by IJCAHPO and ASCRS. The program will have the latest information on cataract and refractive surgical topics with the potential to earn up to 21 IJCAHPO credits over 3 days. Part 1 and 2, which are purchased together with the potential for up to 14 IJCAHPO credits, will take place June 6 from 8:00 a.m.–5:00 p.m. CDT and June 13 from 8:00 a.m.–5:00 p.m. CDT. Part 3, purchased separately, will take place June 27 from 8:00 a.m.–5:00 p.m. CDT for the potential of up to 7 IJCAHPO credits.

ASOA webinar series continues
ASOA continues its eight-part webinar series with supplemental live Q&A. The series—Resuming Your Practice … A Digital Journey of Discovery to Help Restore Normalcy—will have sessions on May 27–28, and June 2–3. The recorded sessions will be available on demand. The series provides 12 COE Category A credits. Find more details here.

COVID-19: News You Can Use
Stay up to date with information about COVID-19 specifically curated for ophthalmologists and their practices with ASCRS’ COVID-19: News You Can Use series. This series is a repository of information including links, tips, and resources to help navigate the fluid COVID-19 landscape, including considerations for reopening practices.

Research highlight
  • Retinal texture could be an early biomarker for Alzheimer’s disease, according to research published in the journal Scientific Reports. Ge Song, a PhD student, and coresearchers obtained depth-resolved light scattering measurements in triple transgenic Alzheimer’s disease mice compared to wild type, age-matched control mice using angle-resolved low-coherence interferometry and OCT. Angle-resolved light-scattering measurements were taken of the nerve fiber layer, outer plexiform layer, and retinal pigmented epithelium. While it had previously been shown that there is retinal thinning associated with Alzheimer’s disease, this paper also shows there is a change in structural texture of the nerve fiber layer of the inner retina in the Alzheimer’s disease mouse model.
  • Findings from a new study could shorten the length of clinical trials for wet and dry AMD by years. The research by Susan Vitale, PhD, and coinvestigators evaluated whether 2-year progression along the Age-Related Eye Disease Study (AREDS) age-related macular degeneration scale could be used to estimate risk of progressing to late-stage disease or loss of visual acuity. The research found a significant association in 2-year progression of AMD score to late AMD and ≥2-line or ≥3-line loss. “… this finding demonstrates the viability of the AREDS AMD scale in describing AMD progression,” Vitale et al. concluded. The research was published in JAMA Ophthalmology.
  • A recent study demonstrated the value of video education for patients as part of the cataract consultation. The study was a prospective survey of patients who were randomly assigned to watch an educational video or not; 101 patients were surveyed, 58 of whom watched the video. According to the study with first author C. Ellis Wisely, MD, patients who viewed the video scored higher on cataract surgery educational assessments (83% compared to 76% who didn’t view the video). Ninety-three percent of patients who watched the video were likely to think their surgeon provided quality explanations compared to 74% of those who didn’t watch. Those who watched the video also trended toward having a greater perception of the surgeon spending enough time with them during the consult, though video education did not affect the face-to-face time between the surgeon and the patients, according to the research. Video education also did not impact choices for multifocal IOLs, toric IOLs, or FLACS. The research is published in the journal Clinical Ophthalmology.

Product news
  • Ocutrx Vision Technologies unveiled its Ocutrx OR-Bot Surgery Visualization Theatre at the ASCRS Virtual Annual Meeting, with its ORLenz augmented reality surgery headset featuring three visualization options for surgeons.
  • Avellino Lab announced its A.C.T.S. (Active Coronavirus Testing & Safety) Program for ophthalmology and other practices performing elective surgery, specifically noting its AvellinoCoV2 FDA-approved SARS-Cov-2/COVID-19 test. Tests are processed in 1–3 hours with most results available within 24 hours.
  • CooperVision’s Biofinity toric multifocal contact lens is now available in the U.S.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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