EW Weekly, June 12, 2020

Objective sign for treatment of dry eye disease
Aldeyra Therapeutics said that it reached an agreement with the FDA for using reactive aldehyde species (RASP) as an objective sign for assessing treatment of dry eye disease (DED). According to the company’s news release, RASP are pre-cytokine, pro-inflammatory mediators that are elevated in tears of patients with DED. RASP also correlate with DED signs and symptoms, the company reported. Aldeyra is developing a first-in-class RASP inhibitor (reproxalap) and is using RASP levels to demonstrate the effect of the drug in clinical trials.

FDA approves updated Beovu label
Novartis updated the prescribing information and label for Beovu (brolucizumab) with collaboration and approval from the FDA. The update includes a subsection on retinal vasculitis, retinal vascular occlusion, and information on the spectrum of intraocular inflammation rates in Phase 3 HAWK and HARRIER trials, the company reported. This news comes after Novartis announced the unmasked, independent analysis of brolucizumab by a Safety Review Committee, which was established after the company began receiving reports of vasculitis following FDA approval of the injection to treat neovascular AMD. In a member update, the American Society of Retina Specialists (ASRS) reported findings from this committee, which included intraocular inflammation of any kind occurring in 4.6% of patients in the HAWK and HARRIER studies. Thirty-six patients had retinal vasculitis out of 1,088 total patients. Of these patients, 23 had vascular occlusion, giving it an overall rate of 2.1%. According to the committee, the risk of developing any sort of intraocular inflammation and losing 15 or more letters was 0.7%. Losing three or more lines of vision or six or more lines of vision in a 2-year period in patients who had retinal vasculitis was 22% and 14%, respectively. According to the committee, most inflammation took place within 6 months post-injection. The ASRS Research and Safety in Therapeutics Committee stated at this time that the risk-benefit profile, including this analysis, should be assessed when considering how to treat individual patients.

Noninvasive retinal imager receives FDA approval
XyCAM RI (Vasoptic Medical) received FDA approval as a noninvasive retinal imager that can measure blood flow in the retina as well as provide images of retinal vessels. According to the company, the device has multiple display modes, including a reconstructed fundus image mode, dye-free angiogram, and colored flow visualization. The company reported that clinical evidence is being gathered by research institutions to support use of XyCAM RI for specific diseases.

ASCRS and IJCAHPO Technicians & Nurses Program virtual broadcast
Technicians and nurses are encouraged to join a virtual broadcast series of topics from the 2020 Technicians & Nurses Program sponsored by IJCAHPO and ASCRS. The program will have the latest information on cataract and refractive surgical topics with the potential to earn up to 21 IJCAHPO credits over 3 days. Part 1, which was purchased together with Part 2 with the potential for up to 14 IJCAHPO credits, took place June 6. Part 2 will take place June 13 from 8:00 a.m.–5:00 p.m. CDT. Part 3, purchased separately, will take place June 27 from 8:00 a.m.–5:00 p.m. CDT for the potential of up to 7 IJCAHPO credits.

Research highlights
  • Post-hoc secondary analysis of two randomized clinical trials (the Ocular Hypertension Treatment Study and the European Glaucoma Prevention Study) sought to evaluate whether long-term intraocular pressure variability could improve prediction of patients progressing from untreated ocular hypertension to primary open-angle glaucoma (POAG). The research included 709 patients and ultimately found that “adding intraocular pressure SD, maximum, range, or coefficient of variation to a model that included mean follow-up intraocular pressure and baseline factors did not significantly increase predictive accuracy.” This, according to Mae Gordon, PhD, and coresearchers, suggests that including long-term IOP variability is not likely to improve prediction models from ocular hypertension to POAG. The research is published in JAMA Ophthalmology.
  • A study assessing the value of intraoperative OCT in DMEK surgery found the technology to be useful in graft orientation, appositioning, and helping to reduce surgical time. According to the study published in Cornea by Marc Muijzer, BSc, and coinvestigators, of the 38 cases analyzed, some included prolonged over pressurization of the globe while others did not. The researchers found intraoperative OCT provided valuable information for surgical decision-making in 43% of cases.
  • A study that looked at the effect of low-dose atropine on ocular biometrics found that there was no clinical effect on corneal power or lens power at the doses (0.05%, 0.025%, and 0.01%) evaluated. The research, led by Li Fen-Fen, MD, and colleagues, showed that the effect on myopia mainly reduced axial length elongation. The study published in Ophthalmology was double-blinded, randomized, placebo-controlled, and included 383 children 4–12 years old.
  • A literature review assessed the outcomes and safety of IOL implantation without zonular support. Forty-five studies (out of 734) were included in the analysis, three with level II evidence and 42 with level III evidence. The studies included eight types of IOL fixation techniques: anterior chamber IOL, iris-claw IOL, retropupillary iris-claw IOL, 10-0 polypropylene iris-sutured posterior chamber IOL (PCIOL), 10-0 polypropylene scleral-sutured PCIOL, 8-0 polypropylene scleral-sutured PCIOL, CV-8 polytetrafluoroethylene, and intrascleral haptic fixation. Joanne Shen, MD, and coresearchers concluded that no one technique showed superiority, with various techniques having similar visual acuity and safety outcomes. The authors acknowledged that each technique has its own risk of complications and wrote that surgeons need to educate patients on the importance of follow-up to monitor the results of these techniques. They also stated that large, prospective studies are needed to assess long-term complications.

Product news
  • BVI launched CryoTreq, a single-use cryo-surgery device for treating retinal tears and detachments, in Europe.
  • The FDA approved Bausch + Lomb’s INFUSE daily disposable contact lenses that include a new material (kalifilcon A) and other technologies designed to address contact lens dryness.
  • M&S Technologies launched web-based, at-home vision testing/screening. The test includes e-ETDRS, ATS/HOTV, and screening protocols.
  • Implandata launched its web-based, remote IOP monitoring EYEMATE IOP-Tracking Service in Europe, allowing patients to collect IOP measurements at home. EYEMATE is CE marked and is in the approval process as a Breakthrough Device with the FDA.

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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