EW Weekly, April 22, 2021

FDA approves next-generation phaco machine
Johnson & Johnson Vision announced FDA approval and the CE mark for its next-generation phacoemulsification system, VERITAS Vision System. According to the company’s press release, this technology is designed to reduce surge and provide surgeons with more stability and better ergonomics. Commercial launch of the product is expected later this year.

Study: Endogenous compound reduces glaucomatous vision loss independent of IOP
Researchers at NYU Grossman School of Medicine have shown that a compound, citicoline, restored optic nerve signaling in glaucomatous rats independent of IOP level. According to a press release from the university, this compound is a known source of choline, which lines nerve cells and enhances their communication. In a paper published in Neurotherapeutics, the investigators described altered structure and function of brain connectivity and visuomotor behavior upon increasing magnitude and duration of IOP elevation in the study animals. Three weeks of oral citicoline in animals with chronic IOP elevation, however, “significantly reduced visual brain integrity loss and visual acuity decline without altering IOP.” This, an investigator said in the press release, shows a different mechanism for glaucoma protection than the current standard of care, reducing and controlling IOP. According to the press release, more research is needed before citicoline is considered to treat glaucoma in human patients. Further research will also include an effort to better understand choline decline in glaucoma patients and how citicoline repairs glaucomatous damage.

Successful transplant of stem cell-derived retinal ganglion cells in lab
The Moscow Institute of Physics and Technology (MIPT) announced what it described as the world’s first successful growth and transplant of retinal ganglion cells derived from stem cells in a laboratory setting. Researchers from MIPT and Harvard Medical School, according to the MIPT press release, grew these mouse retinal cells and transplanted them inside mouse retinas, following viability for 12 months. The cells were able to receive signals, but the press release stated that their ability to transmit signals is yet to be assessed completely. The ultimate goal of this research would be to use a similar method to grow human retinal ganglion cells for transplant in patients whose cells were damaged due to conditions like glaucoma. This, the press release said, is at least 10 years away from being ready for clinical practice. The research findings are published in the journal Molecular Therapy – Methods & Clinical Development.

Phase 2 clinical trial for intravitreal dexamethasone implant
A Phase 2 clinical trial for an intravitreal dexamethasone implant, Ripple Therapeutics’ IBE-814 IVT, for inflammatory retinal diseases has begun, with dosing of its first patient. The multicenter (in New Zealand and Australia), single-masked, dose-ranging study will enroll up to 50 eyes of 50 patients with DME or RVO to evaluate the safety and efficacy of two dosages. Retreatment will be allowed in the study if there are recurrent symptoms, the company’s press release noted. Follow-up will occur for 18 months post-treatment. IBE-814 IVT is designed to deliver a low, sustained dose of dexamethasone over 6 months. According to the company, the implant has a lower dose of dexamethasone than other dexamethasone-releasing intravitreal therapies, with its intention to reduce dose-related adverse effects.

ASCRS events

Research highlights
  • Investigators for a study published in JAMA Ophthalmology sought to determine the incidence and severity of POAG at 20 years of follow-up in participants of the Ocular Hypertension Treatment Study. Twenty-two clinics enrolled patients and followed them from February 1994 through December 2008; data was collected after 20 years of follow-up, from January 2016–April 2019. From February 1994–June 2002 (phase 1), participants were randomized to receive topical ocular hypotensive medication or have close observation. Phase 2 (June 2002–December 2008) had both groups receiving medication. In 2009, according to the paper, “treatment was no longer determined by study protocol.” Participants received exams and visual function assessments between 2016 and 2019. Overall, 46% of study participants developed POAG in one or both eyes within the 20-year timeframe, and cumulative incidence of visual field loss was 25%. POAG in the observation group was 49.3% and 41.9% in the medication group. The authors concluded that this information with a prediction model could help inform treatment of patients with ocular hypertension.
  • A case series of newborns explored the ocular effects of gestational SARS-CoV-2 exposure. Moderate or high risk of ocular involvement was ruled out in this case series of 165 newborns whose mothers were determined to have SARS-CoV-2 infection. Gestational age when exposed to SARS-CoV-2 in utero ranged from 1 to 40 weeks, according to the study. One newborn in the series had retinal vascular tortuosity and venous engorgement, seven had intraretinal hemorrhages, and two had retinopathy of prematurity. None of the newborns in this case series with ocular abnormalities had active SARS-CoV-2 infection within 18 days of birth. Six newborns in the series did test positive for SARS-CoV-2 within 18 days but none of these had ocular abnormalities. The authors of this uncontrolled study, published in JAMA Ophthalmology, advocate for additional controlled studies to confirm findings.

Product news
  • ThermaMEDx launched EverTears, a self-heating, pre-moistened, disposable, sterile cleaning eye pad for treatment of dry eye and MGD symptoms.
  • NIDEK introduced a YAG-SLT combination laser, the YC-200 S plus, and an enhanced YAG laser, the YC-200.

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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