- Topline results from Phase 3 pivotal trial evaluating mydriasis drug
- First person dosed in Phase 3 trial for first-in-class dry eye candidate
- Phase 2 study of a novel glaucoma drop targeting non-traditional outflow
- Digital vision screening platform with machine learning
- Alcon to acquire dry eye drop and inflammation/pain drop
- New issue online
- ASCRS news and events
May 27, 2022 • Volume 28, Number 21
Topline results from Phase 3 pivotal trial evaluating mydriasis drug
Ocuphire Pharma announced topline results from its Phase 3 trial evaluating Nyxol (phentolamine ophthalmic solution) as a mydriasis-inducing drug for treatment of night vision disturbances. The primary endpoint agreed upon by the FDA was met, with Nyxol-treated participants gaining 15 letters or more of mesopic low-contrast distance visual acuity at day 8 compared to placebo (13% vs. 3%). By day 15, 21% of subjects had gained 15 letters or more, while placebo-treated remained at 3%. Forty-one percent and 44% gained 10 lines or more at day 8 and day 15, respectively. There were no serious adverse events, and when there were adverse events, they were mild, according to the company.
First person dosed in Phase 3 trial for first-in-class dry eye candidate
The first participant has been dosed in Aerie Pharmaceutical’s Phase 3 registrational study evaluating AR-15512. AR-15512 is a first-in-class TRPM8 agonist intended to treat the signs and symptoms of dry eye. According to the company’s press release it acts as a cold thermoreceptor modular, stimulating cold-sensing receptors within nerves, leading to natural tear production and a cooling sensation that could reduce dry eye symptoms. This Phase 3 study is the first of three trials; the other two are expected to begin in the second half of 2022 to support a potential New Drug Application in 2024.
Phase 2 study of a novel glaucoma drop targeting non-traditional outflow
Qlaris Bio announced results from its first-in-human Phase 2 clinical trial of QLS-101, an investigational IOP-lowering drop that targets distal outflow resistance and episcleral venous pressure. According to the company, QLS-101 is intended to lower IOP by widening the outflow channels and vessels distal to the trabecular meshwork. The Phase 2 trial showed favorable safety and tolerability with no hyperemia. The company stated that the trial showed a positive efficacy signal in patients with POAG and ocular hypertension.
Digital vision screening platform with machine learning
Retina Technologies (RetTech), a team founded by medical students at the Icahn School of Medicine, is developing OcuVue, a digital vision screening platform with integrated machine learning for general practitioners to use in order to facilitate early detection of vision-threatening conditions. According to the company’s press release, more than 180,000 new cases of vision loss and blindness are identified each year, 80% of which could have been avoided with early detection and subsequent treatment. The press release stated that the modular nature of OcuVue allows for it to be used “virtually anywhere,” conducting comprehensive vision screening and taking retinal imagines in 15 minutes. It also provides interpretations and referrals.
Alcon to acquire dry eye drop and inflammation/pain drop
Alcon announced that it has agreed to acquire Kala Pharmaceuticals’ EYSUVIS (loteprednol etabonate suspension) and INVELTYS (loteprednol etabonate suspension). According to Alcon’s press release, EYSUVIS compliments the company’s Systane family of drops for dry eye management; EYSUVIS is indicated for short-term treatment of dry eye disease. INVELTYS is indicated for twice daily treatment of inflammation and pain after ocular surgery.
New issue online
The June issue of EyeWorld, featuring articles on “Growing your practice with new techniques and technologies,” is online now.
ASCRS news and events
- ASCRS Summer Meeting: Register for the ASCRS Summer Meeting and get a “Taste of ASCRS” over a long weekend, August 19–21, 2022, in Nashville, Tennessee.
- Meet the ASCRS app: Experience ASCRS content in a whole new way with the ASCRS app. Learn more here.
- ASCRS Grand Rounds: ASCRS Grand Rounds, presented by NYU Langone Department of Ophthalmology, is available on demand.
- Ophthalmology Quicksand Chronicles: Watch the latest episode of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD.
Research highlights
- Research published in JAMA Ophthalmology aimed to validate at-home visual acuity tests compared to in-office visual acuity testing. According to the paper, three currently available at-home tests were included in the study (one a printed chart, one a mobile app, and one on a website). Participants with a visual acuity of 20/200 or better (n=121) were recruited from four university ophthalmology clinics and randomized to self-administer two of the three at-home tests 3 days before their in-office visit. Participants were surveyed about usability of the at-home tests, in addition to measurement accuracy being compared between the at-home and in-office test. According to the authors, the mean in-office visual acuity was 0.11 logMAR (20/25). The mean difference between the at-home tests and in-office visual acuity measurements was –0.07, –0.12, and –0.13 for the printed chart, mobile app, and website test, respectively. The authors concluded that these at-home tests were comparable within 1 line to the in-office measurements. They noted that older participants were more likely to have limited access to digital tools. They suggested the need for more development and validation of at-home visual acuity testing to advance teleophthalmology opportunities.
- A new technique to diagnose corneal erosion, called the corneal sweep test, was described in the journal Cornea. According to the paper, a retrospective chart review was conducted on 58 eyes (51 patients) with recurrent corneal erosion from July 2018 to June 2020. The new corneal sweep test was performed as a confirmatory test and on patients who didn’t have visible evidence of corneal pathology. According to the paper, the corneal sweep test was necessary on 49 out of 58 eyes to confirm the diagnosis of corneal erosion; 34 of these had occult corneal erosion. The authors described this test as “a new and effective technique to help diagnose corneal erosions in the absence of visible corneal findings.” Read more about this new test in the latest issue of EyeWorld.
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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