- FDA approves suprachoroidal injection for macular edema associated with uveitis
- FDA approves first-of-its-kind approach to treat wet AMD
- Digital therapeutic for pediatric amblyopia receives FDA premarket approval
- Ocular insert for dry eye does not meet Phase 2 primary endpoint
- Study: Prozac as a possible treatment for AMD
- ASCRS news and events
October 29, 2021 • Volume 27, Number 43
FDA approves suprachoroidal injection for macular edema associated with uveitis
Bausch + Lomb and Clearside Biomedical announced FDA approval of XIPERE (triamcinolone acetonide injectable suspension) for macular edema associated with uveitis. According to the company’s press release, this approval, along with the proprietary SCS Microinjector developed to deliver XIPERE, pioneers a novel treatment approach, with it being the first product approved for suprachoroidal injection and the first therapy approved for macular edema associated with uveitis. The FDA approval is based on a clinical trial of 160 patients with macular edema associated with uveitis; a greater proportion of patients treated with XIPERE (47%) achieved at least a 15-letter improvement in BCVA than patients who were treated with placebo (16%) at 24 weeks, according to the companies. The most common adverse events included elevated IOP and eye pain.
FDA approves first-of-its-kind approach to treat wet AMD
The FDA approved Genentech’s Susvimo, a port delivery system with ranibizumab, for treatment of wet AMD. According to the press release, this is the first new treatment in 15 years to provide an alternative to standard eye injections. The Susvimo system consists of a refillable implant that delivers ranibizumab continuously after one-time surgical insertion. It can be refilled every 6 months, and according to the company, additional wet AMD treatments can still be delivered to the eye with the implant in place, if needed.
Digital therapeutic for pediatric amblyopia receives FDA premarket approval
Luminopia received FDA de novo premarket approval for its Luminopia One prescription, digital therapy for treatment of amblyopia in children ages 4–7. The Luminopia One technology has patients watch therapeutically modified TV shows and movies with a virtual reality headset. The company explained in a press release that proprietary algorithms modify the content selected by the viewer to promote use of the weaker eye. According to the company, this is the first FDA-approved digital therapeutic for children with amblyopia and the first for a neuro-visual disorder.
Ocular insert for dry eye does not meet Phase 2 primary endpoint
Ocular Therapeutix announced topline results from its Phase 2 clinical trial for OTX-CSI (cyclosporine intracanalicular insert) for treatment of dry eye disease, which ultimately found that its primary endpoint of increased tear production at 12 weeks was not met. According to the company, the study groups evaluated against control did not show a statistically significant difference in Schirmer’s test improvements from baseline, but there was an improvement (not statistically significant) compared to baseline in signs of dry eye measured by fluorescein staining and symptoms measured by the visual analogue scale. The insert was safe and well tolerated, according to Ocular Therapeutix.
Study: Prozac as a possible treatment for AMD
Researchers from the University of Virginia School of Medicine published a study in the Proceedings of the National Academy of Sciences that suggested fluoxetine (Prozac, Eli Lilly and Co.) could potentially treat AMD. According to a press release from the university, the researchers have found early evidence that the drug could be effective against dry AMD, showing positive results in lab test and animal models. The researchers also evaluated data from insurance databases of more than 100 million Americans, finding that patients in the database who were taking Prozac were less likely to develop AMD. These findings have the investigators advocating for clinical trials to test the drug with AMD.
ASCRS news and events
- 20/Happy in 2021: The popular ASCRS Master Class in Refractive Cataract Surgery is back with a new CME module—20/Happy in 2021—to be hosted in person during the AAO Annual Meeting in New Orleans, Louisiana. If you’re attending the AAO Annual Meeting, join the complimentary program Saturday, November 13, 5:00–9:00 p.m. CT at Hilton Riverside, St. Charles Ballroom. Learn more.
- ASCRS Winter Symposium: Registration is open for the February 10–12, 2022, Winter Symposium in Park City, Utah. This meeting focuses on the innovative techniques and controversies in anterior segment ophthalmology and will honor Alan Crandall, MD (1947–2020), former co-chair of this meeting, former ASCRS president, and a tireless teacher and humanitarian. Learn more.
- CME opportunity: “ASCRS Satellite CME: Supplemental Education to the ASCRS Annual Meeting” includes four, 1-hour programs captured from the 2021 Annual Meeting that are now available online and on-demand for viewing/claiming credit. Learn more.
Research highlights
- IOL characteristics and their potential association with IOL dislocation after cataract surgery were assessed in a study published in the British Journal of Ophthalmology. The study evaluated medical records from 1996–2017 from the Department of Ophthalmology Graz, Austria, identifying 68,199 eyes from 46,632 patients for inclusion. From this set, 111 eyes had in-the-bag dislocation (0.16%) and 35 had out-of-the-bag dislocation (0.05%). After adjusting for risk factors that were otherwise associated with a higher risk for IOL dislocation, the authors found hydrophilic IOLs, quadripode IOLs, and haptic angulation were significantly associated with a higher risk for in-the-bag IOL dislocation. Silicone IOLs and hydrophilic IOLs were associated with a higher risk for out-of-the-bag dislocation. The authors reported a lower risk of dislocation with use of 3-piece IOLs and those with a larger IOL diameter.
- Different concentrations of atropine for pediatric myopia control were compared in this literature search published in the journal Ophthalmology. Studies included in the analysis were those that used atropine treatment for at least a year. Eight atropine concentrations were identified (1%, 0.5%, 0.25%, 0.1%, 0.05%, 0.025%, 0.02%, and 0.01%) and ranked with corresponding outcomes by P-score. According to researchers, 30 pairwise comparisons from 16 randomized clinical trials were obtained, with 1%, 0.5%, and 0.05% ranking as the most beneficial based on P-scores. For myopia control assessed by relative risk for myopia progression, 0.05% was identified as the most beneficial concentration followed by 1%, according to the authors. With these findings, the authors concluded that ranking probability for efficacy was not proportional to dose.
Product news
- Eyenovia announced that the FDA has reclassified MydCombi, the company’s microdose of tropicamide and phenylephrine for pupil dilation, as a drug-device combination product.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
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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