EW Weekly, December 11, 2020

Two Phase 3 studies for dry eye therapies
This week, two companies—Aldeyra Therapeutics and Novaliq—announced the enrollment of patients for their separate Phase 3 studies evaluating their respective therapies for dry eye disease. Aldeyra Therapeutics enrolled the first patient for its Phase 3 TRANQUILITY study, which is evaluating reproxalap ophthalmic solution 0.25%, for treatment of dry eye disease and allergic conjunctivitis. This small molecule drug is specifically an immune-modulating covalent inhibitor of reactive aldehyde species (RASP), which the company’s press release explained is elevated in patients with ocular and systemic inflammatory disease. This multicenter, randomized, double-masked, parallel design, controlled trial will assess safety and efficacy, with endpoints including effect on tear RASP levels, Schirmer scores, and conjunctival redness. According to the company’s press release, the study will begin with a run-in cohort of 20 patients, the results from which will be used in a main cohort trial. Novaliq enrolled its first patient in its Phase 3 ESSENCE-2 trial, designed to replicate the efficacy of its Phase 2/3 ESSENCE-1 trial, for CyclASol, a topical anti-inflammatory and immunomodulating ophthalmic solution that contains 0.1% cyclosporine A in a water-free technology, according to the company’s press release. Novaliq’s study will enroll about 834 patients from 25 U.S. centers with primary endpoints being change in total corneal staining and eye dryness score, as well as an objective measure of visual function (reading speed).

Separate payment for OMIDRIA
Omeros Corporation announced that CMS confirmed a separate payment for OMIDRIA (phenylephrine and ketorolac intraocular solution). According to the company’s press release, this separate payment qualification comes under CMS’ policy for non-opioid pain management surgical drugs used in ASCs. Separate payment is effective retroactively as of Oct. 1, 2020. OMIDRIA is FDA approved to prevent pupil constriction during cataract or lens replacement surgery and to reduce postop pain.

New company formed to develop ophthalmic antibody therapies
Maze Therapeutics and Alloy Therapeutics have partnered to create Broadwing Bio, a company that will create targeted antibody therapies for ophthalmic diseases, according to a Maze Therapeutics press release. The press release stated that the company’s targets will be genetically validated using Maze Therapeutics’ human genetics and functional genomics platform, while Alloy Discovery Services will generate therapeutic candidates.

Collaboration to advance AI in ophthalmology
Novartis Pharma and RetinaAI Medical announced a multi-year collaboration to work on projects in ophthalmology and digital health, according to a press release. The first will involve neovascular AMD, evaluating use of OCT images and AI in assessment of disease activity. This study, according to the press release, is being conducted in Europe and Canada and includes more than 500 patients.

The latest ASCRS initiatives
  • Grand Rounds: ASCRS will continue its Grand Rounds, a virtual CME event for ASCRS members, on December 16 at 8 p.m. EST with the Cullen Eye Institute at Baylor College of Medicine. The moderators, Terry Kim, MD, and Sumitra Khandelwal, MD, along with Baylor faculty will cover case presentations, offer clinical pearls, and host a panel discussion. This CME offering is approved for 1.0 AMA PRA Category 1 Credit.
  • Podcast: ASCRS launched its new podcast—Ophthalmology Quicksand Chronicles with Nicole Fram, MD, and Elizabeth Yeu, MD—last month. Each episode of the podcast will include discussion of cases that did not go as planned—the “quicksand” moments—with the hosts and guests reflecting on lessons learned from their experience. Listen to previous and upcoming podcasts on YouTube or by subscribing to it on Spotify, Apple, Google, Stitcher, or TuneIn by searching “Ophthalmology Quicksand Chronicles.”
  • Journal Club: The first ASCRS Journal Club took place on Tuesday with a panel of experts discussing two pre-selected manuscripts from the Journal of Cataract & Refractive Surgery. Nick Mamalis, MD, and Leela Raju, MD, are the co-moderators of these free, CME sessions, open to all ASCRS members. For more information, go to ascrs.org/clinical-education/journal-club.

Research briefs
  • A small case series is suggesting that clinicians should be aware of the possibility of increased IOP from periorbital edema when patients being treated for COVID-19 are in a prolonged prone position, causing compression of their eye and orbit. Researchers described two cases of orbital compartment syndrome and optic disc edema and retinal hemorrhages in ICU patients with COVID-19 in JAMA Ophthalmology. The cases were observed in a review that included 16 patients in the ICU with the virus, four of whom required prolonged prone-position ventilation. In addition to the other ocular observations in two of these four patients, the study authors noted a two- to three-fold increase in IOP. They suggest use of protective cushioning around the eyes and keeping the patient’s head above heart level.
  • New research published in Advanced Science proposes a drug-free, non-surgical, relatively long-term approach to glaucoma management with a technique that expands the suprachoroidal space. According to the research, injection of an “in situ-forming hydrogel” into the suprachoroidal space can increase drainage of aqueous humor from the eye, lowering IOP. The researchers used a commercial hyaluronic acid hydrogel and optimized hyaluronic acid hydrogel injected into the suprachoroidal space of rabbits and observed an IOP reduction for 1 and 4 months, respectively. The researchers wrote that ultrasound biomicroscopy showed a correlation between IOP reduction with the expansion of the suprachoroidal space. There was minor hemorrhage and fibrosis near the injection site, according to the study. The researchers concluded that “[suprachoroidal space] expansion with an in situ‐forming hydrogel can enable extended IOP reduction for treating ocular hypertension and glaucoma without drugs or surgery.”

Product news
  • Tilak Healthcare partnered with Novartis Pharma for international promotion of its OdySight app, a validated mobile app for remote vision monitoring.

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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