- New visual prosthesis heads to clinical trial
- FDA grants Fast Track designation to investigational wet AMD therapy
- Patient enrollment complete in Phase 3 trial for investigational, first-in-class eye drop for DED
- FDA agrees to pivotal trial design for investigational treatment of geographic atrophy secondary to AMD
- ASCRS news and events
July 16, 2021 • Volume 27, Number 28
New visual prosthesis heads to clinical trial
Researchers at Illinois Tech announced that a new type of visual prosthesis will head to clinical trial as part of the NIH’s Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative. According to Illinois Tech’s press release, the prosthesis is a brain implant for patients who are totally blind due to retina or optic nerve damage but who have an intact visual cortex. Its intracortical implant design uses wireless simulators. The research will evaluate whether people who are totally blind can visualize rendered images in real time through visual perception, the press release explained.
FDA grants Fast Track designation to investigational wet AMD therapy
The FDA granted Ophthea’s OPT-302, a VEGF-C/-D “trap” inhibitor, in combination with anti-VEGF-A therapy Fast Track designation. OPT-302 is under investigation for treatment of wet AMD and is currently beginning two Phase 3 clinical trials. The first will evaluate OPT-302 in combination with ranibizumab and the second will evaluate OPT-302 in combination with aflibercept. The studies will compare the combination treatments with ranibizumab or aflibercept monotherapy, respectively.
Patient enrollment complete in Phase 3 trial for investigational, first-in-class eye drop for DED
Bausch + Lomb and Novaliq announced completion of patient enrollment for the second of two Phase 3 clinical trials investigating NOV03 (perfluorohexyloctane), a first-in-class eye drop designed to treat signs and symptoms of DED associated with MGD. A total of 622 participants were enrolled. According to the companies’ press release, NOV03 is a water-free, preservative-free solution that uses Novaliq’s EyeSol technology.
FDA agrees to pivotal trial design for investigational treatment of geographic atrophy secondary to AMD
IVERIC bio announced that the FDA agreed to its pivotal clinical trial of Zimura (avacincaptad pegol) for treatment of geographic atrophy secondary to AMD under a special protocol assessment. GATHER2, a Phase 3 clinical trial, plans to complete patient enrollment later this month, according to the company’s press release, and is designed to support a New Drug Application, if results are positive. The FDA recommended, and IVERIC accepted, that the primary efficacy endpoint in the GATHER2 trial should be the mean rate of change in geographic atrophy area over 12 months measured by fundus autofluorescence at three timepoints (baseline, month 6, and month 12) compared to the mean rate of growth (slope) estimated based on geographic area measured by fundus autofluorescence in at least these three timepoints.
ASCRS news and events
- 2021 ASCRS Annual Meeting: The Annual Meeting in Las Vegas, Nevada, begins next week. Last-minute registration is available.
- Government Relations effort: CMS released the 2022 Medicare Physician Fee Schedule (MPFS) Proposed Rule this week with a conversion factor that is a decrease of about 3.89% ($1.31) from the CY 2021 MPFS conversion factor. This is largely a result of the expiration of a 3.75% increase to the conversion factor at the end of CY 2021, as averted for 2021 by congressional action when the Consolidated Appropriations Act was signed into law and a reflection of the budget neutrality adjustment of –0.14% and the 0.00% update adjustment factor as established in MACRA. ASCRS will be submitting comments. Read ASCRS’ news alert on the topic.
Research highlights
- A study published in the journal Cornea compared corneal biomechanical properties and corneal tomography in eyes with keratoconus that had either transepithelial customized crosslinking (C-CXL) or epithelium-off accelerated crosslinking (A-CXL). Twenty eyes for each group were included in the retrospective comparative study. The researchers found significant improvements in biomechanical parameters in the C-CXL group. There was also a significant decrease in Kmax, higher-order irregularities, and asymmetry components in this group. According to the researchers, biomechanical properties and AS-OCT parameters were not significantly different in the A-CXL group postop. The researchers reported a greater effect of C-CXL on improving maximum inverse radius, deformation amplitude ratio max, integrated radius, Kmax, asymmetry component, and higher-order irregularity component compared to A-CXL. This led them to conclude that C-CXL might provide better biomechanical properties and improve irregular shape in the early postop period compared to A-CXL.
- A retrospective cohort study published in the journal Ophthalmology compared the rate of postoperative endophthalmitis following immediately sequential bilateral cataract surgery (ISBCS) with delayed sequential bilateral cataract surgery (DSBCS). The study used data from 2013–2018 from the IRIS Registry. Of the more than 5.5 million patients in the registry who had cataract surgery during this timeframe, 165,609 had ISBCS (leaving 5,408,030 who had DSBCS or unilateral cataract surgery). According to the paper, 3,102 met study criteria. The rate of endophthalmitis between the two groups was similar; 0.059% in the ISBCS group vs. 0.056% in the DSBCS/unilateral group. The odds ratio between the two groups was not statistically significant.
Product news
- Carl Zeiss Meditec announced its new ZEISS Medical Ecosystem, which integrates devices, data management, applications, and services to improve patient outcomes
- CATS announced FDA approval of its CATS-D Disposable Prism, a disposable tip replacement for the Goldmann tonometer. The CATS-D will be available for purchase this fall.
- Bausch + Lomb launched Biotrue Hydration Boost Lubricant Eye Drops and Biotrue Micellar Eyelid Cleansing Wipes, both preservative free.
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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