EW Weekly, January 22, 2021

Enrollment complete for Phase 3 studies of investigational dry eye drug
Enrollment of 599 participants in two Phase 3 studies for a first-in-class investigational dry eye drug is complete, according to a press release from Bausch + Lomb. The company is studying NOV03 (perfluorohexyloctane), which is a water-free, preservative-free ophthalmic solution, for the signs and symptoms of dry eye disease associated with meibomian gland dysfunction. NOV03 includes EyeSol technology, which is patented by Novaliq and exclusively licensed by Bausch + Lomb for the development and commercialization of NOV03 in the U.S. and Canada. A previous Phase 2 study evaluating safety, efficacy, and tolerability of NOV03 saw significant improvement in fluorescein staining compared to control over 8 weeks and improvement in symptoms of dry eye severity, frequency of dryness, and burning/stinging during the study course, the company’s press release stated.

Update from two Glaukos trials
Glaukos announced results from trials for two of its devices. One was a Phase 2b clinical trial for its intracameral iDose TR sustained-release travoprost implant. Interim analysis (24-month data) from this ongoing 36-month, multicenter, randomized, double-blind trial evaluating different release rates of the travoprost implant compared to topical timolol BID revealed a 7.9 mm Hg and 7.4 mm Hg average IOP reduction from baseline in the fast- and slow-release iDose groups, compared to 7.8 mm Hg in the control group. Another finding was that 23% and 20% of participants in the fast- and slow-release groups, respectively, had IOP reductions of at least 40% from baseline, compared to 13% in the control group. The safety profile of iDose TR was favorable, according to the company. Separately, Glaukos released data from its 12-month U.S. Investigational Device Exemption pivotal trial for the iStent infinite Trabecular Micro-Bypass System. This prospective, unmasked, single-arm trial included two types of patients: 1) those who previously had unsuccessful incisional or cilioablative glaucoma surgery and who were uncontrolled on IOP-lowering medications or 2) patients who had not undergone such procedures and were uncontrolled on maximally tolerated medications. At 12 months, 76% of participants achieved a 20% or greater reduction in mean diurnal IOP from baseline (baseline mean 23.4 mm Hg) with the same or lower medication load; 50% of participants saw a 30% or greater IOP reduction. The average reduction in medication load at 12 months was 13%. Glaukos reported a favorable safety profile.

Study: Remote monitoring with implantable IOP sensor affects clinical decision making
Implandata announced data that showed telemedicine can be effective for glaucoma patients in situations where they might not want to visit the clinic, such as during the COVID-19 pandemic. Published in the journal Ophthalmology Glaucoma, the study showed how Implandata’s EYEMATE system resulted in physicians changing their therapy for 29% of patients without them having to enter the office. According to the company, this data shows that remote technology like this system can help prevent vision loss while allowing patients to avoid possible virus exposure during an office visit. The study, which included 37 eyes of 37 patients with either a suprachoroidal sensor or sulcus-based sensor, showed “patient acquired measurement of IOP in conjunction with remote IOP monitoring by physicians as feasible with an implantable sensor,” the study authors wrote.

ASCRS events
  • Upcoming webinar: Register for “The Holy Grail of Presbyopia Correction: IOL Technologies Today and Tomorrow to Meet Our Patients’ Needs,” occurring on January 27, 8–9 p.m. EST.
  • January’s ASCRS Journal Club is available to view and claim CME credit.
  • January’s Grand Rounds presented by the John A. Moran Eye Center, University of Utah, is available to view and claim CME credit.

Research highlights
  • Research published in the British Journal of Ophthalmology sought to quantify lens nuclear opacity with swept source anterior segment OCT (SS-ASOCT), ultimately finding that SS-ASOCT nuclear density measurements closely correlated with the current classification protocol, the Lens Opacities Classification System III (LOCS-III). The study authors secondarily found that the use of SS-ASOCT could accurately diagnose a hard nuclear cataract, which could be useful for operative planning. The researchers think that this technology “has the potential to be extensively applied in eye health examinations and effective screening of patients with cataract” with objective results that are not dependent on slit lamp settings, patient involvement as in a visual acuity testing, and/or experience with LOCS-III grading.
  • A medical record review of 80 consecutive patients from a single center sought to evaluate the efficacy of punctal cauterization in the management of dry eye disease. The average follow-up was 27 months post-cauterization. The indications for punctal cauterization were plug loss (n=51), plug fitting issues (n=11), plug complications (n=6), recanalization (n=7), and severe OSD (n=4). The study authors reported the percentage of eyes classified with severe and moderate dry eye decreased significantly (21% and 25%, respectively). More than half (54%) of patients reported improved symptoms. There was a recanalization rate of 21% with topical corticosteroids being associated with a higher recanalization rate. The study authors concluded in part that punctal cauterization is “an effective modality in treating severe ocular surface diseases in patients who repeatedly lose punctal plugs.” The research is published in the journal Cornea.
  • According to a paper published in the journal Cornea, crosslinking has been used in mice as an experiment to reduce corneal neovascularization, a risk factor for graft rejection after high-risk penetrating keratoplasty. This research evaluated the safety and efficacy of crosslinking in this application in five human subjects. According to the research, one case had peripheral crosslinking performed followed by peripheral crosslinking combined with PK. The other four cases only had peripheral crosslinking combined with PK. There were no intraoperative or postop complications. The crosslinking reduced corneal neovascularization by a mean of 70.5%±22.7%. There was no revascularization and all transplants were clear during the mean follow-up of 16.4±14.9 weeks. With these findings, the authors concluded that crosslinking could be used to “improve graft survival after high-risk PK.”

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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