- Twelve-month results for Phase 2 trial evaluating heat-therapy system for MGD
- Topline results from targeted photobiomodulation for treatment of progressive myopia
- Enrollment complete in Phase 3 trials to evaluate new wet AMD therapy
- ‘Low tech’ way to prioritize cataract surgery
- ASCRS news and events
May 31, 2024 • Volume 30, Number 22
Twelve-month results for Phase 2 trial evaluating heat-therapy system for MGD
Sight Sciences announced 12-month results from its Phase 2 randomized controlled trial evaluating efficacy of its TearCare System for signs and symptoms of dry eye in patients who were also treated with cyclosporine ophthalmic emulsion, 0.05%, for the first 6 months, then discontinued this prescription drop for the latter half of the study. According to the study, the improvement in signs and symptoms observed with TearCare persisted for 6–12 months without cyclosporine use. The company’s press release noted that this data shows the value of prioritization of interventional eyelid treatment. The research is published in the journal Clinical Ophthalmology.
Topline results from targeted photobiomodulation for treatment of progressive myopia
Dopavision announced topline results from its randomized clinical trial of 125 children with myopia who received treatment with MyopiaX, a targeted photobiomodulation system, or control (randomization was 2:1). After 6 months, the MyopiaX treatment, according to the company’s press release, showed a positive clinical effect on reducing the rate of myopia progression and was found to be safe and tolerable. The trial will conclude in September 2024, after which time the company plans to have discussions with regulatory authorities for a developmental and approval pipeline for what it describes as a “first-in-class, targeted intervention that non-invasively stimulates specific cells in the eye to regulate innate signaling pathways and slow the rate of myopia progression.”
Enrollment complete in Phase 3 trials to evaluate new wet AMD therapy
Ophthea announced that it has completed enrollment for its two Phase 2 pivotal trials designed to evaluate safety and efficacy of sozinibercept in combination with standard anti-VEGF-A therapy compared to standard-of-care alone in the treatment of wet AMD. According to the company’s press release, 1,984 patients were enrolled for the two trials; one trial will assess efficacy of sozinibercept in combination with aflibercept and the other in combination with ranibizumab. The primary endpoint is mean change in BCVA from baseline to week 52. According to the company, sozinibercept is a soluble form of vascular endothelial growth factor receptor 3; it binds and neutralizes activity of VEGF-C and VEGF-D. Previous research has associated sozinibercept with prevention of blood vessel growth and vascular leakage.
‘Low tech’ way to prioritize cataract surgery
A paper published in the journal Eye is proposing a “low tech” way to prioritize cataract surgery for those who need it most in areas where there might be a waitlist. The authors describe the feasibility of a mail delivered contrast sensitivity test (SpotChecks) that prospective patients take at home, without the supervision of medical professionals, to determine eyes that most required surgery. The test was sent to 233 people waiting for a cataract assessment and was returned by 46% (216 eyes). The contrast sensitivity scores sent in on the pen-and-paper test were used to predict the eyes that were listed for surgery. The authors noted that “predictive performance was further improved when machine learning was used to combine CS scores with letter acuity” from patient medical records. Thirty-nine patients had clinic follow-up testing, and the authors found that the home CS scores correlated with biometry signal-to-noise, logMAR acuity, Pelli-Robson CS testing, and SpotChecks CS testing. The authors concluded that this direct mail method with pen-and-paper CS tests “may be a feasible, ‘low-tech’ way of prioritizing patients on cataract waiting lists.”
ASCRS news and events
- ASCRS Live!: This dinner series, making its way to nine cities, is continuing to bring ASCRS education around the U.S. Next up: Houston, Texas, on June 13. Register now.
- ASCRS 50th Anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.
- ASCRS Annual Meeting: Hotel blocks are open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025.
Research highlights
- A prospective, randomized, comparative study sought to compare safety, efficacy, and changes in endothelial cell density after standard phacoemulsification in the setting of dense cataracts (grade 3.0 or above) vs. femtosecond laser-assisted cataract surgery (FLACS) in the same setting. The study randomized 100 eyes of 100 patients to conventional phaco or FLACS. The conventional group had a significantly higher mean total phaco time compared to FLACS (11.17±6.5 seconds vs. 8.03±3.77 seconds, respectively) as well as a longer effective phacoemulsification time and total surgical time. The volume of irrigation fluid was comparable, according to the authors. Mean corneal edema score and central corneal thickness values were significantly higher postop day 1 in the conventional group and, at 6 months, endothelial cell density loss was significantly higher in the conventional group as well (16.08% in conventional compared to 12.8% in FLACS). The authors of the paper, which was published in the Journal of Cataract & Refractive Surgery, concluded that “FLACS with customized nuclear fragmentation patterns resulted in significantly less intraoperative phacoemulsification time, surgical time, and endothelial cell loss compared with conventional phacoemulsification when treating dense cataracts.”
- Experience with immediate sequential bilateral cataract surgery (ISBCS) for patients with visually significant cataracts and reduced preop CDVA was reported in the journal Clinical Ophthalmology. The research included 1,335 patients (2,670 eyes). After ISBCS, the authors reported that 50.2% and 89.1% of eyes achieved UCVA of 20/20 or better and 20/32 or better, respectively. Most (83.8%) were within ±0.50 D of emmetropia; 96.4% were within ±1.0 D of emmetropia. The authors reported intraoperative adverse events occurring in 14 eyes of 13 patients and 86 postop adverse events occurring in 80 eyes of 52 patients for a 2.996% per eye incidence. CME was the most common postop adverse event. There were no patients with bilateral CDVA loss. The authors concluded that ISBCS “resulted in good refractive predictability and a low incidence of serious adverse events.”
Product news
- Health Canada has approved the enVista Envy (Bausch + Lomb) IOL full visual range IOL.
- The European Commission granted Marketing Authorization to Outlook Therapeutics for LYTENAVA (bevacizumab gamma) for treatment of wet AMD.
This issue of EyeWorld Weekly was edited by Stacy Jablonski, Liz Hillman, and Ellen Stodola.
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: Sumit “Sam” Garg, MD, Chief Medical Editor, Mitchell Weikert, MD, Cataract Editor, Karolinne Rocha, MD, PhD, Refractive Editor, Julie Schallhorn, MD, Cornea Editor, Manjool Shah, MD, Glaucoma Editor
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