EyeWorld Weekly, June 10, 2022

EyeWorld Weekly, June 10, 2022

EyeWorld Weekly

June 10, 2022 • Volume 28, Number 23

FDA approves brolucizumab injection for DME

Novartis announced FDA approval of BEOVU (brolucizumab-dbll) for DME. According to the company’s press release, this is the second indication approved for BEOVU, the first being for wet AMD in 2019. There is a loading phase of five doses of BEOVU injected 6 weeks apart. After this phase patients are injected every 8–12 weeks. The press release described two Phase 3 studies that led to the approval, showing that intraretinal fluid, subretinal fluid, or both at 52 weeks was 60.3% with BEOVU and 73.3% with aflibercept in one study and 54.2% with BEOVU vs. 72.9% with aflibercept in another. The company’s press release stated that patients who received BEOVU demonstrated a significant reduction in central subretinal thickness from baseline, beginning at week 4 and continuing to week 52.

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NDA filed for geographic atrophy drug

Apellis Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for intravitreal pegcetacoplan for geographic atrophy secondary to AMD. Pegcetacoplan is a targeted C3 therapy that, according to the company’s press release, is the “only treatment” to have shown potential to slow disease progression in three large studies with a real-world population of patients with geographic atrophy. Pegcetacoplan is designed to regulate excessive activation of the immune system’s compliment cascade. The company stated that the FDA’s decision on the NDA filing is expected in August 2022. Apellis also plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022. Pegcetacoplan has a Fast Track designation from the FDA for geographic atrophy.

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Study: Dietary supplements can slow AMD progression

News from the National Eye Institute on the Age-Related Eye Disease Studies (AREDS and AREDS2), specifically the 10-year results of the AREDS2 data, stated that a formulation of supplements that substituted lutein/zeaxanthin in place of beta carotene reduced risk of progression to late AMD. The study, published in JAMA Ophthalmology, sought to evaluate the effect of the supplements from AREDS2 in development of lung cancer and progression of late AMD. The cohort included 3,882 participants and 6,351 eyes, showing that lung cancer development was nearly double in participants who were assigned to the group receiving the formulation with beta carotene who were former smokers; this was not observed in those who received the lutein/zeaxanthin formulation. In the press release, one of the researchers stated that the goal was to create an effective supplement formula that could safely be used by anyone, whether or not they smoke(d). The 10-year data, the researcher stated, confirms that the formula with lutein/zeaxanthin instead of beta carotene is not only safer but better at slowing AMD progression.

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First global study evaluates AI for diabetic retinopathy and referral uptake

Orbis announced findings from what the press release described as the “first global study” that evaluated the utility of artificial intelligence (AI) for diabetic retinopathy screening and referral uptake. According to a press release, the study in Rwanda found that AI enhanced patient speed and uptake of referral services. The study, published in Ophthalmology Science, included 823 patients with diabetes who met inclusion criteria, 275 of whom had referrable diabetic retinopathy based on the AI screening. These participants were randomized into an intervention or control group. According to the study, referral adherence was significantly higher in the intervention group compared to control. The authors reported that the “immediate feedback on referral status based on AI-supported screening was associated with statistically significantly higher referral adherence compared to delayed communication of results from human graders.” With these results, the authors stated that there is a benefit to AI screening in promoting adherence to treatment for diabetic eyecare.

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Plans to begin two Phase 3 trials for investigational thyroid eye disease therapy

Immunovant announced that it achieved alignment with the FDA for its two Phase 3 clinical trials that will evaluate batoclimab for thyroid eye disease. According to the company’s press release, it plans to initiate these trials in the second half of this year. The placebo-controlled trials will be followed by an open label extension that will enroll subjects from the original studies. The trials will enroll about 100 patients each, with participants randomized to receive treatment or placebo (treatment will include 12 weeks of 680-mg batoclimab followed by 12 weeks of 340-mg batoclimab). Both treatment and placebo will be delivered via subcutaneous injection. According to the press release, the primary efficacy endpoint of the studies will be responder analysis (patients with a 2 mm or more reduction in proptosis from baseline) vs. placebo. Topline results from the trials are expected in the first half of 2025.

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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: Watch the latest ASCRS Grand Rounds, presented by the University of California San Diego, Shiley Eye Institute, online now as an ASCRS member benefit. 
  • Ophthalmology Quicksand Chronicles: Log in to watch the latest episode of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD. 
  • New issue online: Read the June issue of EyeWorld.

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Research highlights

  • A “real-world” observational study with a heterogenous patient population, which included patients with glaucoma and other ocular comorbidities, as well as diverse surgical procedures and concomitant medications, evaluated dexamethasone intraocular suspension for inflammation management after cataract surgery. The study included 527 patients (641 eyes), 66 (80 eyes) of whom had a history of glaucoma. Overall, the patients treated with the intraocular dexamethasone had “favorable inflammatory and visual outcomes, without unanticipated safety problems,” the authors wrote. The percentage of eyes with an anterior chamber cell grade of 0 increased from 40% at postop day 1 to 89.7% at postop day 30 (similar results were observed in eyes with glaucoma history). Anterior chamber flare grade 0 increased from 78.4% on postop day 1 to 97.1% on postop day 30. At day 30, 96.6% of eyes had achieved their target visual acuity, and mean IOP was 15.2 mm Hg or less. There were 22 adverse events (in 20 patients) with the most common being IOP increase; all adverse events were mild to moderate. The study was published in Clinical Ophthalmology. 
  • Investigators sought to evaluate the outcomes of bilateral cataract surgery in children 2–7 years old compared to outcomes in cataract surgery performed on infants and toddlers who were part of the Toddler Aphakia and Pseudophakia Study (TAPS). One hundred and fourteen eyes from 57 children were included in the study with a mean age of 4.4 years at the time of cataract surgery. According to the paper, at the follow-up visit closest to 10 years old, the median BCVA in the better-seeing eye was 20/22 and 20/30 in the worse-seeing eye. Strabismus surgery was performed in 1 patient. The authors reported adverse events in 4 of the first-operated eyes, which they noted is significantly less than that in the two TAPS cohorts (1–7 months and 7 months–2 years). None of the eyes in the study developed glaucoma or were considered glaucoma suspects. The authors concluded that compared to the TAPS cohorts, bilateral cataract surgery performed between 2–7 years old was associated with significantly fewer adverse events and resulted in excellent visual acuity. This research was published in the Journal of AAPOS.

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Product news

  • BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab, Genentech), for treatment of wet AMD, macular edema after retinal vein occlusion, and myopic choroidal neovascularization has launched in the U.S. and will be commercially available July 1.

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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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