EW Weekly, March 5, 2021

FDA accepts NDA for fixed-combination mydriatic agent
Eyenovia announced FDA acceptance of its NDA for MydCombi, a fixed-combination mydriatic agent to be used in comprehensive eye exams. According to the company’s press release, this agent is designed with Eyenovia’s microdose array print technology, which, if approved, would make MydCombi the first microdosed ocular therapeutic. It is administered using the company’s touchless Optejet smart delivery system. The company’s press release stated that the NDA submission is based on two Phase 3 trials of a fixed-combination, microdose of tropicamide 1% and phenylephrine 2.5% ophthalmic solution. About 94% of treated eyes in these studies achieved 6 mm or greater dilation 35 minutes after dosing. Adverse events occurred in less than 1% of patients and included blurred vision, reduced acuity, photophobia, and pain at the instillation site, the press release stated.

NDA accepted by FDA for dry eye nasal spray
The FDA accepted Oyster Point Pharma’s NDA for OC-01 (varenicline), a nasal spray for dry eye signs and symptoms. A Phase 3 and two Phase 2 clinical trials supported the NDA submission, according to the company’s press release. These trials demonstrated statistically significant improvements in signs with OC-01, compared to controls, and a statistically significant or nominally statistically significant improvement in symptoms by at least day 28. There were no serious drug-related adverse events in the trials.

NDA submitted for drop to treat presbyopia
Allergan submitted an NDA to the FDA for AGN-190584 (pilocarpine 1.25%) ophthalmic solution to treat symptoms of presbyopia. Two Phase 3 clinical studies with AGN-190584 showed a statistically significant improvement in near vision in low light conditions without loss of distance vision, compared to control. There were no serious adverse events related to treatment; non-serious adverse events, which occurred in 5% of patients or less, were headache and conjunctival hyperemia. The company’s press release reported that it expects action from the FDA on the NDA by the end of 2021.

Study to assess outcomes of ab interno canaloplasty
Nova Eye Medical announced that eight U.S. surgery centers are participating in a prospective, multicenter, randomized trial to assess safety and efficacy of ab interno canaloplasty performed as a standalone procedure. The study will evaluate the factors that impact clinical outcomes of the procedure and will compare outcomes with the iTrack Canaloplasty Microcatheter (Nova Eye Medical) and the OMNI Surgical System (Sight Sciences). The impact of type of OVD used in the procedure and the volume delivered will also be assessed, according to the company’s press release. The trial will enroll up to 160 patients with mild to moderate uncontrolled POAG who are on 1–4 mediations. It will take place over a 12-month period. Results from the study are expected in the second half of 2022.

Largest study of glaucoma genetics published
In an effort that could lead to new treatment targets, more than 34,000 people with glaucoma were involved in the largest study of glaucoma genetics to date, which compared genes of people with the disease to more than 349,000 controls. A press release from Massachusetts Eye and Ear, which led the research recently published in Nature Communications, stated that 44 new genetic variants were identified and 83 previously identified gene loci were confirmed. In addition to the number of patients involved in the study being notable, the institution’s press release reported that this study presents the first time a genome-wide association study was conducted with a cross-ancestry comparison. Genetic data in this study included people of European, African, and Asian descent; according to the press release, previous studies had mostly looked at data from people of European descent. The researchers found that most loci contributing to glaucoma were consistent across the three groups. With this information, the press release stated that future research will focus on these genetic loci for improved screening, diagnosis, and treatment options. Other research could focus on genes that cause glaucoma and mechanisms for the disease, according to the press release.

Iridex and Topcon enter into strategic agreement
Iridex and Topcon have entered into a strategic collaboration. According to an Iridex press release, the collaboration includes: funding for strategic growth initiatives; Topcon obtaining exclusive distribution rights of Iridex glaucoma and retina products in certain markets, in addition to a 10.4% common equity stake in Iridex; and Iridex acquiring Topcon’s PASCAL product line, allowing it to combine the Iridex Micropulse technology with the PASCAL laser platform.

COVID-19 vaccine update
The FDA issued emergency use authorization to a third COVID-19 vaccine. The COVID-19 vaccine from Janssen (a pharmaceutical company of Johnson & Johnson) joined the Pfizer-BioNTech and Moderna vaccines as options available in the U.S. The Janssen vaccine is indicated for individuals 18 and older. According to the FDA’s press release, the Janssen vaccine is manufactured with adenovirus type 26 (Ad26), which delivers a piece of DNA that is used to make the SARS-CoV-2 “spike” protein to trigger the body’s immune system to learn and prepare for an immune response should the patient be exposed to SARS-CoV-2 in the future. For more vaccine updates, read this article in the latest issue of EyeWorld.

ASCRS Journal Club on March 11
Plan to join ASCRS’ interactive Journal Club on Thursday, March 11, from 9:00–10:00 P.M. ET for another session of this monthly series in which a panel of experts discuss two pre-selected manuscripts from the Journal of Cataract & Refractive Surgery. Nick Mamalis, MD, and Leela Raju, MD, co-moderate these free CME sessions, open to all ASCRS members. The March session will feature Divya Srikumaran, MD, and Matthew Santos, MD, as discussants, and David Chang, MD, Eric Donnenfeld, MD, and Alice Epitropoulos, MD, as panelists.

Research highlights
  • A study published in the journal Eye evaluated the effect of polyvinylpyrrolidone-iodine (PVP-I) 0.6% eye drops on adenoviral keratoconjunctivitis (AKC). Fifty-nine patients confirmed positive for AKC completed the study; 34 patients (group A) received PVP-I four times daily for 20 days, while 25 patients received artificial tears (group B, control) for the same frequency and duration. Group A was found to have a significantly shorter time for resolution of AKC and lower incidence of subepithelial corneal infiltrates (SEIs). Only 8.82% of patients in group A had SEIs at the last visit compared to 44% in group B, the authors reported. They also noted no side effects in either group. The investigators concluded that while PVP-I can have a positive effect on AKC resolution and lower risk of SEIs, further evaluation is needed.
  • A rural ophthalmology practice in the U.S. Midwest conducted economic analysis to evaluate, based on real-world, retrospective data over a 12-month period, how many FLACS procedures would be required per month to break even within 5 years on the investment of the femtosecond laser technology. The clinic brought FLACS into its ASC in 2017 and within the first year performed 2,717 cataract surgeries, 1,304 (48%) of which were FLACS, according to the study published in the journal Clinical Ophthalmology. Of the FLACS procedures, 47% of patients selected an advanced technology IOL (toric or presbyopia-correcting). Comparing advanced technology IOL use to that in the prior year, there was a 23% increase in use of these IOLs when offered with FLACS. The study reported that 13 FLACS cases per month would allow the facility to break even on the investment within 5 years.

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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