- FDA approves drops for vernal keratoconjunctivitis
- Data from investigational first-in-class dry eye therapy
- FDA accepts BLA for Port Delivery System of ranibizumab
- Companies enter collaboration to investigate treatments for dry AMD
- ASCRS news and events
July 2, 2021 • Volume 27, Number 26
FDA approves drops for vernal keratoconjunctivitis
Santen has received FDA approval for Verkazia (cyclosporine ophthalmic emulsion, 0.1%), eye drops for treatment of vernal keratoconjunctivitis in children and adults. According to the company’s press release, Verkazia is an oil-in-water cationic emulsion that improves the bioavailability of the cyclosporine treatment, which the company stated further inhibits T-cell activation and reduces immune cells and mediators causing allergic inflammation on the ocular surface. In two randomized, double-masked, vehicle-controlled clinical trials, Verkazia showed improvements in keratitis scores and ocular itching; adverse reactions included eye pain (12%) and eye pruritus (8%) upon instillation, according to Santen.
Data from investigational first-in-class dry eye therapy
BRIM Biotechnology released results from its Phase 2/3 clinical trial and announced that it held a Type C meeting with the FDA to prepare for a Phase 3 trial for its investigational dry eye therapy, BRM421. According to the company’s press release, BRM421 is a first-in-class peptide based on the company’s stem cell regenerative short peptide technology platform. The company stated that BRM421, in a Phase 2/3 trial with more than 200 patients, showed significant improvements in visual analogue scale dryness, burning and stinging, and photophobia by day 8. It also demonstrated corneal repair at day 15. There were no serious adverse events, and all study participants completed the trial, according to the company’s press release. BRIM Biotechnology is preparing for a Phase 3 trial in 2022.
FDA accepts BLA for Port Delivery System of ranibizumab
Genentech announced that the FDA accepted its Biologics License Application (BLA), giving it priority review, for its Port Delivery System of ranibizumab for wet AMD. According to the company’s press release, if approved by the FDA, this would be a first-of-its-kind therapeutic approach for wet AMD, an alternative to eye injections. The company stated that the FDA’s decision is expected by Oct. 23, 2021.
Companies enter collaboration to investigate treatments for dry AMD
Ocular Therapeutix and Mosaic Biosciences are entering into a discovery collaboration to identify new targets and therapeutic agents to treat dry AMD. According to a press release from Ocular Therapeutix, the companies plan to focus on novel complement inhibitors with extended duration of activity with the goal of blocking the pathway that initiates and drives the disease.
ASCRS news and events
- ASCRS continues to encourage its members to voice opposition against Aetna’s policy requiring prior authorization for cataract surgery procedures, which went into effect July 1. This mandate will negatively impact cataract patients who need surgery to restore their vision by leading to delayed surgery. ASCRS is encouraging physicians and administrators to contact Aetna directly to voice their opposition. Read more here.
- Episode #9 of the Ophthalmology Quicksand Chronicles podcast, featuring Brandon Ayres, MD, is online now. Watch/listen here.
- There’s still time to register for the ASCRS Annual Meeting, the first major ophthalmology society meeting to take place in person since the pandemic began. Join ASCRS in Las Vegas, Nevada, July 23–27. Learn more and register.
- Plan to join ASCRS’ interactive Journal Club on July 8, from 9:00–10:00 p.m. ET for another session in this monthly series in which a panel of experts will 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 July session will feature Jake McMillin, MD, and Hetal Ray, MD, as discussants, and M. Bowes Hamill, MD, Nathan Radcliffe, MD, and Karolinne Rocha, MD, PhD, as panelists.
Research highlights
- The effect of home education due to COVID-19 restrictions on myopia progression was evaluated in 115 children 8–17 years old. The study participants had myopia diagnosed prior to the pandemic with at least 3 years of follow-up beforehand. The researchers evaluated various factors for this study, including time spent in front of a screen/digital devices, time spent outside, refractive error prior to home education, and changes in myopia. According to the study published in the journal Eye, the increase in myopia progression in 2020 was statistically significant compared to the increase observed in 2019 and 2018. The myopia progression was less in children who engaged in outdoor (open air) activities for 2 hours a day and among those who lived in detached houses.
- A literature review published in the journal Ophthalmology evaluated the efficacy of botulinum toxin type A (BTXA) as a treatment for strabismus. Fourteen articles were included in the analysis; two were randomized clinical trials, three were non-randomized comparative studies, and nine were case series. According to the research, four of the five comparative studies showed successful motor outcomes after BTXA injection (60%). In these four studies, successful motor outcomes after surgical revision for strabismus was 66–77%. The authors stated that these outcomes were not significantly different from the outcomes of BTXA injection. With these and other findings, the study authors concluded that BTXA can achieve a high rate of motor alignment compared to surgical correction for strabismus. They stated that good alignment might require multiple BTXA injections and noted that it’s not clear what the sensory differences might be between the BTXA injections vs. surgery in younger children.
Product news
- CXL Ophthalmics received a patent for its UV-A device for transepithelial corneal crosslinking, part of its EpiSmart system.
- Johnson & Johnson Vision’s TECNIS Synergy and TECNIS Synergy Toric II IOLs are now commercially available in the U.S. and Canada.
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: 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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