EW Weekly, May 8, 2020

Interim data for wet AMD gene-therapy trial

Adverum Biotechnologies announced interim data from cohorts 1–3 of its OPTIC Phase 1 clinical trial for a gene-therapy injection for patients who required frequent anti-VEGF injections for wet AMD. ADVM-022 is an intravitreal injection, and in the dose-ranging trial it showed continued tolerance and efficacy as well as long-term durability past 1 year after a single injection in cohort 1, according to a company press release. Cohort 1 (six patients with a median follow-up of 60 weeks) received a higher dose of the gene-therapy injection (6 x 10^11 vg/eye) and did not require any rescue injections in more than a year. This group took a 13-day course of oral prophylactic steroids. Cohort 2 (six patients with a median follow-up of 36 weeks) received a lower dose of ADVM-022 (2 x 10^11 vg/eye) and received a 13-day oral prophylactic steroid regimen. This group saw eight total rescue anti-VEGF injections (two patients). Cohort 3 (nine patients with a median follow-up of 20 weeks) also received the lower dose (2 x 10^11 vg/eye) and took prophylactic steroid eye drops for 6 weeks. This group had two anti-VEGF rescue injections (one for the first five patients). This early evidence suggests the prophylactic steroid eye drop regimen reduced adverse events and led to less inflammation. Early observations also show those in cohort 3 had a mean CTR4 reduction of –137.3 mm and mean BCVA gain of +6.8 letters from baseline.

Using gold nanoparticles to target specific cells for gene therapy

While most gene therapies currently use viral vectors to deliver the therapeutic genes, researchers at Nanoscope Technologies published a study that showed how gold nanoparticles could target specific retinal cells for specific gene delivery. This, according to a press release from the National Eye Institute, could help address challenges of using viral vectors for ocular gene therapy, such as targeting specific areas of the retina, controlling how long genes are expressed, and avoiding immune system activation. According to the press release, the gold nanoparticles with proteins to bind to targeted retinal cells were injected into the vitreous of mice. This was followed by injection of the therapeutic genetic material. Then, a low-intensity infrared light triggered targeted cells to take up the genetic material. According to the press release, the researchers are testing this technology in other clinical models and hope to have it ready for early clinical trials in 2 years. The current study is published in Molecular Therapy: Methods & Clinical Development.

ICare USA launches two diagnostic devices

ICare USA launched a new confocal fundus imaging system and next-generation handheld tonometer this week. The company announced the release of its Centervue DRSplus confocal fundus imaging system, which uses white LED light to produce “TrueColor and detail-rich images,” according to a press release from the company. The company explained that this technology produces higher resolution retinal images. The iC200 handheld tonometer is based on a rebound measuring principle and doesn’t require anesthetic drops, an air puff, or any specialized skills, according to ICare.

NDA resubmitted for new dry eye drug

Kala resubmitted a New Drug Application to the FDA for EYSUVIS (loteprednol etabonate ophthalmic suspension, 0.25%) for dry eye disease. According to the company, the resubmitted NDA is in response to the complete response letter received from the FDA where it requested positive data from an additional clinical trial to demonstrate efficacy. Kala’s positive results from its STRIDE 3 study with other data from previous EYSUVIS clinical trials serve as the basis for this resubmission.

Bausch + Lomb licenses right to create a biosimilar candidate to Lucentis

Bausch + Lomb entered into a licensing agreement with STADA Arzneimittel and Xbrane Biopharma to create a biosimilar candidate to Lucentis (ranibizumab, Genentech). U.S. patents for Lucentis expire this year. According to a press release from Bausch + Lomb, the companies hope to obtain currently approved indications for Lucentis in the U.S. and Canada. STADA and Xbrane will be responsible for finalizing development of the biosimilar, Xbrane will provide the commercial supply, and Bausch + Lomb will be responsible for sales, marketing, and other commercialization efforts following regulatory approval, the press release reported.

ASCRS Virtual Annual Meeting and COVID-19: News You Can Use

The 2020 ASCRS Virtual Annual Meeting is set for May 16–17, tailored to the new digital space with a variety of live and on-demand educational sessions, including the two-part “Turning the Lights Back On” symposium offering a comprehensive overview of what ophthalmologists and administrators need to know to safely reopen their practices. A keynote address from former FDA Commissioner Scott Gottlieb, MD, discussing the COVID-19 pandemic and the path forward is scheduled for May 17 at 8:00 a.m. ET. There will also be opportunities for interaction with industry through corporate-sponsored educational sessions and a full digital exhibit hall. For those already registered for the 2020 ASCRS Annual Meeting, registration will automatically be transferred to the 2020 ASCRS Virtual Annual Meeting. Visit annualmeeting.ascrs.org for updates and information. ASCRS also continues its COVID-19: News You Can Use series, a repository of information including links, tips, and resources to help navigate the fluid COVID-19 landscape, including more recently considerations for reopening practices.

ASOA webinar series

Starting today, ASOA is beginning an eight-part webinar series with supplemental live Q&A. The series—Resuming Your Practice … A Digital Journey of Discovery to Help Restore Normalcy—will have sessions on May 8, May 11, May 18, May 27–28, and June 2–3. Recorded sessions will also be available on-demand. The series provides 12 COE Category A credits. Find more details here.

Research news
  • Secondary analysis of patients from the Laser in Glaucoma and Ocular Hypertension (LiGHT) randomized controlled trial comparing visual outcomes of patients treated with medicine first or SLT first showed that slightly more patients treated with medicine first had more rapid visual field progression compared to SLT first. According to the research published in Ophthalmology by David Wright, PhD, and coresearchers, 26.2% of eyes in the medicine-first group had moderate or fast total deviation progression compared to 16.9% in the SLT group. The researchers reported no statistical difference in the proportion of eyes in the medicine-first vs. SLT-first groups that underwent moderate or fast pattern deviation (9.9% vs. 7.1%, respectively).
  • A literature search that included 12 studies in its analysis found intense pulsed light therapy can help improve signs and symptoms as treatment for MGD and other meibomian gland-related ocular surface disease. Edward Wladis, MD, and coresearchers found that all studies evaluated showed improvement in tear breakup time, corneal staining, meibum quality, gland expressibility, and OSDI and SPEED scores. The paper’s authors noted that there were some methodological limitations and potential conflicts of interest in the published studies. The literature review is published in Ophthalmology.
  • Six toric IOL formulas (Abulafia-Koch, Barrett, EVO 2.0, Holladay 2 with total SIA, Kane, and Næser-Savini) were evaluated in a retrospective case series study by Jack Kane, MBBS, and Benjamin Connell, MBBS. One surgeon inserted Alcon SN6AT(2-9) IOLs in 823 eyes (823 patients), and patients had preop and postop biometry. Vector calculation predicted postop refractive astigmatism with each of the formulas, which was then compared to the actual postop refractive astigmatism. The authors found the Kane formula achieved highest proportion of eyes (65.6%) within ±0.50 D of target, followed by Barrett (59.9%), Abulafia-Koch (59.5%), EVO 2.0 (58.9%), Næser-Savini (56.7%), and Holladay 2 (53.9%). The research can be found in Ophthalmology.

Product news
  • Santen is beginning to transition to using environmentally friendly biomass plastic materials in its eye drop bottles, starting with Timoptol (timolol).

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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