EyeWorld Weekly, July 15, 2022

Study: Specific form of AMD linked to high risk of heart disease

A paper published in Retina from researchers at the Icahn School of Medicine at Mount Sinai provides data that a specific form of AMD is linked to a higher risk of developing cardiovascular disease and stroke. A press release from Mount Sinai stated that while there has been an association between AMD and heart disease before, this is the first to demonstrate the link. Specifically, the study included 126 patients with AMD who were analyzed with OCT and answered a questionnaire about their health history, which included heart disease and stroke. Sixty-two patients in the study were identified as having subretinal drusenoid deposits, and 64 had drusen. Of these 126, 51 had cardiovascular disease or experienced a stroke, and the majority of these patients (66%) had the presence of subretinal drusenoid deposits. According to the press release, AMD patients with cardiovascular disease were 3 times more likely to have the presence of these deposits. The researchers suggested that heart and vascular disease compromises circulation in the eye, which leads to the deposits, the press release stated.

Primary endpoints achieved in study of dry eye therapy

Aldeyra Therapeutics announced that it achieved the primary endpoints of its sequence-randomized, double-masked, vehicle-controlled crossover clinical trial of 0.25% reproxalap ophthalmic solution for treatment of dry eye. According to the company’s press release, the reproxalap group, after a single day of dosing, was statistically superior to vehicle in terms of ocular redness in a dry eye chamber and Schirmer test scores. The effect of reproxalap on ocular redness was observed as quickly as 10 minutes and was maintained, in most cases, for up to 90 minutes (the length of time inside the dry eye chamber), the press release noted. According to the company, there were no safety signals, and reproxalap was well tolerated.

First patient enrolled in study for new pharmacologic presbyopia therapy

Eyenovia announced enrollment of the first patient in its Phase 3 clinical trial of ARVN003 (MicroLine) for pharmacologic treatment of presbyopia. The study, taking place in partnership with Artic Vision in China, is the first approved to evaluate a topical presbyopia therapy in China. Artic Vision, in addition to having an exclusive license from Eyenovia for the development and commercialization of ARVN003 (MicroLine) in Greater China and South Korea, also has an exclusive license for its MicroPine for treatment of pediatric myopia and MydCombi for pharmacological mydriasis.

Company submits IND for advanced AMD treatment candidate

OliX Pharmaceuticals announced that it submitted an investigational new drug (IND) application to the FDA to evaluate safety and tolerability in a Phase 1 study of its OLX10212 candidate for treatment of advanced AMD.

Acquisition of topical dosing technology

Novartis announced that it acquired Kedalion Therapeutics and its AcuStream technology, which is a device targeting precise and accurate topical ophthalmic drug delivery. According to the company’s press release, AcuStream allows for preservative-free drug delivery via an electromechanical delivery method. Novartis, the company continued, plans to develop the technology to potentially use with its topical medications like Xiidra (lifitegrast) and other front-of-the-eye therapies.

Patent granted for oral drug candidate targeting retinal diseases

Ocuphire Pharma received an extended patent for its oral product candidate APX3330. The patent will expire in 2038 and expands coverage for APX3330. APX3330, according to the company’s press release, is an oral, first-in-class inhibitor of the transcription factor regulator Ref-1. The company stated that the drug has a novel mechanism of action that blocks downstream pathways involved in angiogenesis and inflammation that are implicated in several ocular diseases, including diabetic retinopathy, DME, and AMD. APX3330 is in a Phase 2 clinical trial for diabetic retinopathy; it has demonstrated a favorable safety profile thus far.

Complimentary access to video journal

The latest issue of the 2022 Video Journal of Cataract, Refractive, & Glaucoma Surgery, founded and edited by Robert Osher, MD, is online now.

ASCRS news and events

  • ASCRS Summer Meeting: Register for the ASCRS Summer Meeting to get a “Taste of ASCRS”—its focused, anterior segment CME and in-person experience—August 19–21, in Nashville, Tennessee.
  • Ophthalmology Quicksand Chronicles: Episode 3 of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, is now online.

Research highlights

  • A prospective, randomized trial published in the American Journal of Ophthalmology sought to evaluate whether the orientation of the optic-haptic junction of an IOL could decrease the incidence and/or severity of dysphotopsias. The study included 163 patients (326 eyes) from a private practice that all received a TECNIS monofocal IOL (Johnson & Johnson Vision). The patients were randomly assigned to have the optic-haptic junction positioned vertically, horizontally, superonasally, or inferonasally. Patients with known visual field defects or BCVA less than 20/80 were excluded. Patients were asked about dysphotopsias at week 1 and weeks 4–6. The investigators found that the orientation of the optic-haptic junction was significantly associated with incidence of negative dysphotopsia with horizontal orientation performing the best. Patients with the superonasal positioning had the worst outcomes in terms of dysphotopsia experience. There were no differences among the positioning groups for positive dysphotopsia incidence or severity.
  • Risk factors for needing a repeat keratoplasty after an endothelial keratoplasty were assessed in a retrospective cohort study that used data from 2013–2018 from the Intelligent Research in Sight (IRIS) Registry. The registry identified 59,344 procedures, 30,600 of which met the inclusion criteria. There was a 17.4% need for repeat keratoplasty at 5 years with risk factors for repeat including postop rebubbling, prior failed graft or bullous keratopathy vs. Fuchs as the surgical indication, cataract surgery, glaucoma surgery or history of glaucoma, Medicare fee-for-service or Medicare managed insurance vs. private insurance, black vs. white race, and history of smoking. The research is published in the American Journal of Ophthalmology.

Product news

  • Bausch + Lomb began a series of efficiency-enhancing upgrades for its Stellaris Elite vision system, including an increase to the maximum vacuum setting and removable valve caps in the trocar/cannula system.
  • IVERIC bio and DelSiTech entered into an exclusive global license agreement to create a sustained-release version of Zimura (avacincaptad pegol). The companies stated that the technology could be used to treat geographic atrophy and intermediate AMD.
  • Alimera Sciences received approval for ILUVIEN (fluocinolone acetonide intravitreal implant) for the prevention of recurrent non-infectious uveitis affecting the posterior segment from the Italian Medicines Agency.

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: Sumit “Sam” Garg, 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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