EW Weekly, April 10, 2020
- FDA issues guidance on remote ophthalmic assessment, monitoring devices
- Preliminary safety, efficacy results in model for dry eye disease
- NCX 4251 moves into Phase 2b trial
- Study: Laser cataract surgery
- ASCRS announces 2020 Virtual Meeting
- COVID-19: News You Can Use
April 10, 2020
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Volume 26 ,
Number 14
FDA issues guidance on remote ophthalmic assessment, monitoring devices
The FDA issued guidance this week to expand the capability of remote ophthalmic assessment and monitoring devices, allowing physicians to care for patients while reducing exposure and spread of COVID-19. According to a press release from the administration, the policy—Process for Making Available Guidance Documents Related to Coronavirus Disease 2019—remains in effect for the duration of the COVID-19 pandemic.
Preliminary safety, efficacy results in model for dry eye disease
ProtoKinetix announced preliminary safety and efficacy results for PKX-001 in an animal model for dry eye disease. According to a press release from the company, PKX-001 (5%) delivered QID topically in the murine model of acute desiccating stress showed protective, reduced corneal permeability compared to control (CsA-MiDROPS, cyclosporine A microemulsion, EyeCRO). The molecule, according to ProtoKinetix, demonstrated anti-inflammatory and cytoprotective properties and it is moving to the next stage of clinical development.
NCX 4251 moves into Phase 2b trial
Nicox, after meeting with the FDA, is moving its NCX 4251 compound for blepharitis and dry eye disease into a Phase 2b trial. Results from its Phase 2 study, announced earlier this year, showed a reduction in signs and symptoms for these conditions, leading Nicox to meet with the FDA to agree upon trial designs for a larger Phase 2b study with NCX 4251 0.1% QD. According to Nicox, NCX 4251 is a fluticasone propionate nanocrystal ophthalmic suspension.
Study: Laser cataract surgery
Scientists from ITMO University and the S.N. Fyodorov Eye Microsurgery Complex published research that describes a new technique in “energetic cataract surgery.” In Optical and Quantum Electronics the researchers describe using two simultaneous laser wavelengths to destroy the cataractous lens and prevent postop inflammatory processes. According to the research, a high-intensity, Nd:YAG laser (endodissector) uses a wavelength of λ = 1.44 µm, while a low-intensity helium-neon laser (endobiostimulator) uses a wavelength of λ = 0.632 μm. The researchers wrote that the laser tip does not heat up and laser energy does not extend beyond the lens capsule. The study authors wrote that the combination of high- and low-intensity simultaneous lasers via one tip can prevent the progression of the posttraumatic inflammatory process.
ASCRS announces 2020 Virtual Meeting
ASCRS announced that the 2020 Annual Meeting will be held virtually on May 16–17. The 2020 ASCRS Virtual Meeting will be tailored to the new digital space and will include a variety of live and on-demand educational sessions. The virtual meeting will include a selection of symposia and instructional courses in a live stream format. Paper sessions, posters, films, and a selection of pre-recorded instructional courses will be available on-demand with full slides, video, and audio. There will also be opportunities for interaction with industry through corporate-sponsored educational sessions and a full digital exhibit hall. For those already registered for the 2020 ASCRS Annual Meeting, registration will automatically be transferred to the 2020 ASCRS Virtual Meeting. Visit annualmeeting.ascrs.org for updates and information.
COVID-19: News You Can Use
ASCRS continues its COVID-19: News You Can Use series, a repository of information including links, tips, and resources to help navigate the fluid COVID-19 landscape. The e-newsletter is published as new information relevant to its members emerges.
Research briefs
- A case report of a 30-year-old patient with COVID-19 described bilateral acute conjunctivitis occurring 13 days after the beginning of the illness, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Reverse transcription PCR detected SARS-CoV-2 in the patient’s conjunctival swabs. Conjunctival swabs remained positive for the virus at day 14 and 17 after illness onset, but on day 19, RT-PCR was negative for the virus. The study authors note that this case shows the potential for viral conjunctivitis at the middle of the COVID-19 illness, necessitating exam precautions throughout the clinical course. The paper was published in the British Journal of Ophthalmology.
- Nicotinamide, a form of vitamin B3, can inhibit and partially reverse the process leading to fibrotic eye diseases, Nathan Boles, PhD, and coresearchers found. The study found that nicotinamide downregulates transcriptional changes that cause an epithelial to mesenchymal transition in retinal pigment epithelium, which can lead to fibrosis, retinal scar tissue, and retinal detachment. The research signals a potential therapeutic pathway for patients with fibrous epiretinal membrane, macular puckers, and proliferative vitreoretinopathy, Boles et al. wrote. The study is published in Stem Cell Reports.
- A prospective cohort study of 11 male and female astronauts found long-duration spaceflight of 6 months was associated with optic disc edema and peripapillary choroidal thickening bilaterally during flight. Anterior chamber depth and axial length were reduced after spaceflight, and according to the study by Brandon Macias, PhD, and co-researchers, a hyperopic shift can be observed 1 year post-flight. The research published in JAMA Ophthalmology expands upon previous retrospective analysis of ocular changes in astronauts.
- A randomized clinical trial of 52 patients with neovascular AMD receiving anti-VEGF treatment showed topical dorzolamide-timolol did not result in better vision compared to placebo from baseline to 3 months. It did, however, lead to reduced macular edema in those with persistent exudation. The mean change in central subfield thickness from baseline to 3 months in the dorzolamide-timolol group was −36.6 μm (1.7 μm in the placebo group). Change in visual acuity from baseline to 3 months was −2.3 letters in the dorzolamide-timolol group and 0.3 letters in the placebo group (a difference of 2.6 letters; 95% CI, −1.9 to 7.1 letters; P=.78). The study authors suggest the need for a larger sample size to fully determine the role of dorzolamide-timolol for patients with neovascular AMD. The research is published in JAMA Ophthalmology.
- Regular eyeliner use leads to greater tear film instability and meibomian gland dysfunction, according to a cross-sectional study of 42 volunteers without dry eye symptoms. The research by Pinnita Prabhasawat, MD, and coinvestigators evaluated female volunteers 18–40 years old who either used eyeliner regularly (more than 3 days per week for more than 6 months) or didn’t use it regularly. Participants took a questionnaire about ocular symptoms and were examined for conjunctival inflammation, tear breakup time, ocular surface staining, Schirmer I testing, meibomian gland function, Demodex, and other eyelid margin abnormalities. Demodex, Schirmer’s scores, staining, and ocular surface symptoms were not different between the two groups, but tear breakup time was significantly lower in the eyeliner group compared to controls (3.0 ± 1.9 vs. 5.8 ± 2.1 s, P<0.001), and meibomian gland grading was higher with a grade of 2–3 found in 85.7% of eyeliner wearers compared to 47.6% of controls. Telangiectasia was seen in 28.6% of those who wore eyeliner compared to 4.8% of controls. The research is published in Cornea.
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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