EW Weekly, October 16, 2020

Rare pediatric disease and orphan drug designations granted for retinoblastoma treatment
Oxular Limited announced that it has received rare pediatric disease and orphan drug designations from the FDA for its investigational treatment for retinoblastoma. OXU-003, according to the company’s press release, contains an anti-tumor drug that is delivered adjacent to the primary ocular tumor for local or targeted chemotherapy. In preclinical models, the drug has proved effective as a standalone or complementary therapy, the company’s news release stated. The hope is for OXU-003 to be effective while having fewer risks and side effects that are associated with current retinoblastoma treatments.

Bausch Health licenses microdose formulation of atropine
Bausch Health has licensed an investigational therapy from Eyenovia that could be used to prevent pediatric myopia progression. The treatment is a microdose formulation of atropine ophthalmic solution that is delivered via Eyenovia’s Optejet dispenser to administer the correct dose and developed with the company’s microdose array print (MAP) technology. With this agreement, Bausch Health is taking on oversight and costs of the current Phase 3 CHAPERONE clinical trial of the atropine formulation, which is being investigated in children 3–12 years old.

Phase 2 trial for acute exacerbations of blepharitis
Nicox SA is initiating a Phase 2 trial of NCX 4251 0.1%, focusing its trial (named Mississippi) on acute exacerbations of blepharitis. If primary endpoints are met, the company stated in a press release that it could be the first of two pivotal trials needed to support a New Drug Application. NCX 4251 is an ophthalmic suspension of fluticasone propionate nanocrystals. The company stated that it thinks this is the first time this corticosteroid (fluticasone propionate) is being developed for an ophthalmic indication. It also stated that NCX 4251 is the first product candidate being developed as a targeted topical therapy of the eyelid margin for patients with acute exacerbations of blepharitis. The previous Danube Phase 2 trial was completed in 2019, yielding a statistically significant reduction in the composite score of eyelid redness, eyelid debris, and eyelid discomfort at day 14, based on pooled analysis of once-daily and twice-daily dosing. The Mississippi trial will evaluate once-daily dosing of the drug against a placebo with topline results expected in the fourth quarter of 2021, according to Nicox.

First patient dosed in a Phase 1 study for DME therapy
The first patient has been dosed in a Phase 1 study of UNITY Biotechnology’s UBX1325 for advanced DME. According to the company’s press release, evidence supports an association between disease progression and accumulation of senescent cells. UBX1325 is a selective small molecule inhibitor of Bcl-xL (an anti-apoptotic regulatory protein), which preclinically was able to eliminate senescent cells and, according to the press release, have a positive effect on inflammation, vascular leakage, and visual function. The Phase 1 trial is a first-in-human, open-label, single-ascending dose study to evaluate safety, tolerability, and pharmacokinetics. It will enroll about 15 total patients with safety and tolerability data expected in the first half of 2021 and initiation of a proof-of-concept study within that timeframe as well.

Open-label safety study for bevacizumab-vikg for wet AMD
A supplemental open-label safety study for ONS-5010/Lytenava (bevacizumab-vikg) for wet AMD was initiated by Outlook Therapeutics, according to a company press release. According to Outlook Therapeutics, the study will include about 180 patients with a range of retinal diseases that can be treated with anti-VEGFs, including wet AMD, DME, and branch retinal vein occlusion. Patients in the study will receive three doses of ONS-5010 over a 3-month period. Data from this study, from the already completed clinical experience trial, the proof-of-concept, and the ongoing pivotal Phase 3 trial will support the potential for a new biologics license application.

Research highlights
  • A retrospective, matched, case-control study took a look at the outcomes of PRK in eyes with posterior corneal steepening (n=89) compared to those without posterior corneal steepening (n=954). Before and after PRK, there was significantly reduced CDVA and lower central corneal thickness in the eyes with posterior corneal steepening compared to controls. The study authors also reported significantly higher preop and postop Baiocci Calossi Versaci (BCV) index for the back of the cornea, as well as symmetry index of the front and back of the cornea, in the group with posterior corneal steepening. The BCV for the front of the cornea was lower after surgery. There was one case of ectasia. The investigators concluded that “PRK on corneas with posterior steepening results in similar refractive outcomes compared to normal eyes, 1 year following surgery.” The research is published in the journal Eye.
  • A decrease in clinical workload during the early months of the COVID-19 pandemic likely freed up clinicians to work on research and academic pursuits, a study published in the journal Eye stated, as it found an increase in ophthalmology-related publications. The researchers compared the number of ophthalmology publications from January–August 2020 to 2019 numbers, and there was a 22.1% increase. The authors noted a more prominent increase (28.8%) between March–August 2020. They found that during this timeframe, 3.9% of papers were related to COVID-19 and after adjusting for COVID-19-related publications, found a 5.3% average annual growth rate since 2016. The study authors wrote that a 9.4% increase of publications from March–August 2020 could “not be attributed to a specific factor.” They later speculated the uptick was “attributable to a decrease in clinical workload and more time available for research as well as academic activities.”

Product news
  • HOYA launched a new app, CLEARlog (Cataract & Lens Exchange Analysis & Register log), designed to help surgeons record and analyze their practice patterns and outcomes for these procedures.
  • New World Medical registered KDB Glide as a Class 1 device, with new features for the Kahook Dual Blade (KDB) technology to increase precision. According to the company, KDB Glide will soon be available in the U.S.

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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