EyeWorld Weekly, February 18, 2022

EyeWorld Weekly, February 18, 2022

February 18, 2022 • Volume 28, Number 7

Nerve growth factor being studied as a possible treatment for Sjogren’s-related dry eye

Dompe announced that it began two Phase 3 multicenter trials to evaluate the safety and efficacy of cenergermin for severe dry eye related to Sjogren’s disease. Currently Oxervate (cenergermin-bkbj) is approved for neurotrophic keratitis with a recombinant form of human nerve growth factor to support corneal innervation, the company stated. One of the randomized, placebo-controlled studies looking into the utility of this topical product for severe dry eye related to Sjogren’s will enroll 100 patients and assess signs and symptom improvement over time. The second study will enroll 48 patients who are currently being treated with cyclosporine for severe dry eye related to Sjogren’s. According to Dompe, there is no FDA-approved treatment for severe Sjogren’s-related dry eye disease; current management is focused on replacing moisture and suppressing the autoimmune response.

Back to top

Investigational RNA therapy doesn’t meet primary endpoint

ProQR Therapeutics announced that its Phase 2/3 trial of sepofarsen for treatment of Leber congenital amaurosis 10 did not meet its primary endpoint of BCVA at month 12. Sepofarsen (QR-110) is an investigational RNA therapy that was designed to restore vision caused by a mutation in the CEP290 gene. The study had enrolled 36 patients 8 years or older with a specific mutation on this gene and randomized them to receive sham or one of two doses of sepofarsen administered via intravitreal injection. In general, the treatment was well tolerated but at month 12, mean change from baseline BCVA was –0.11 logMAR (p=0.96) in one treatment group, –0.13 logMAR (p=0.97) in another treatment group, and –0.12 logMAR in the sham group. Full-field stimulus tests and mobility did not show a difference between the treatment and sham groups in topline analysis, according to the company.

Back to top

Phase 1 clinical trial for bioerodible, sustained anti-VEGF delivery

EyePoint Pharmaceuticals released interim data from its Durasert and Vorolanib in Ophthalmology (DAVIO) Phase 1 clinical trial of EYP-1901, a bioerodible, sustained-delivery of anti-VEGF treatment for wet AMD. No serious adverse events or drug-related systemic adverse events were reported, nor were there reports of vitreous floaters, endophthalmitis, retinal detachment, implant migration into the anterior chamber, retinal vasculitis, or posterior segment inflammation. The press release stated that 41% of treated eyes did not need supplemental anti-VEGF injections out to 9 months following one dose of EYP-1901. BCVA at 8-months’ follow-up was stable, as was central subfield thickness. The company also reported a 75% reduction in treatment burden. EyePoint Pharmaceuticals reaffirmed plans to initiate a Phase 2 trial of EYP-1901 later this year.

Back to top

Positive interim data for diabetic retinopathy treatment

REGENXBIO announced additional positive interim data from its ongoing Phase 2 ALTITUDE trial of RGX-314, an investigational one-time gene therapy, for treatment of diabetic retinopathy without center-involved DME. The treatment is injected into the suprachoroidal space in the office. The company reported that the treatment has thus far been well tolerated with two serious, though not drug-related, adverse events. Of the 15 patients within Cohort 1, seven at 6 months showed a two-step or greater improvement from baseline on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale, according to the company’s press release; zero patients in the observational group showed an improvement. One patient dosed with RGX-314 demonstrated a four-step improvement.

Back to top

Positive results in trial for high-dose aflibercept

Regeneron Pharmaceuticals announced positive results from its Phase 2 proof-of-concept trial evaluating a high dose (8 mg) of aflibercept compared to the currently approved 2-mg dose (EYLEA) for wet AMD. New results showed continued numeric improvements in anatomical and vision outcomes, compared to EYLEA, through 44 weeks.

Back to top

Additional Phase 3 trial data for Beovu in DME

Novartis announced additional positive results from its three Phase 3 trials evaluating Beovu (brolucizumab) for DME. The company has already applied for FDA and EMA approval for this indication. Among the many new findings were that visual acuity gains achieved in year 1 were maintained in year 2 and were comparable to aflibercept, though Beovu had fewer injections. A 1-year study comparing Beovu and aflibercept at a 4-week dosing interval showed that Beovu was non-inferior in visual gains and superior in fluid-related secondary endpoints.

Back to top

ASCRS news and events

Back to top

Research highlights

  • A prospective cohort study used data from the Pediatric Eye Disease Investigator Group clinical research registry to evaluate the 5-year outcomes of patients younger than 13 who had cataract surgery. The data from June 2012–July 2015 identified 994 children (1,268 eyes) from practices within the U.S., Canada, and U.K. who had lensectomy for any reason. The authors reported a modest myopic shift during the 5 years postop, which they wrote should be considered when selecting a lens power. They also saw that development of glaucoma or glaucoma suspect was common (46% in bilateral aphakic patients and 25% in unilateral aphakic patients). As such, the authors stated that the results support the necessity of frequent monitoring of a pediatric population post-cataract surgery. They also wrote that surgery to clear the visual axis was performed in 1 out of every 3 pseudophakic eyes. The study is published in the journal Ophthalmology. 
  • As the multisystem pathology of COVID-19 infection continues to be understood and researched, a study published in the journal Cornea described some of the effects that are being reported after vaccination as well. The paper reported on a few cases of herpes zoster ophthalmicus (HZO) after patients received a live COVID-19 vaccine. One case was a 35-year-old patient who developed HZO 3 days post-vaccine. The second case was a 40-year-old who developed HZO 28 days post-vaccine. The authors reported that this is among the first literature describing HZO occurring after live COVID-19 vaccination.

Back to top

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

For sponsorship opportunities or membership information, contact: ASCRS • 12587 Fair Lakes Circle • Suite 348 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ascrs@ascrs.org

Mention of products or services in EyeWorld Weekly does not constitute an endorsement by ASCRS.

Click here to view our Legal Notice.

Copyright 2022, EyeWorld News Service, a division of ASCRSMedia. All rights reserved.

Tags: , , , ,