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Quick Notes: February 10, 2023

Phase 3 studies show Genentech’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion; CDC recommends patients and health-care providers immediately discontinue using EzriCare artificial tears; and more.

Ophthalmology Management February 10, 2023
  • Genentech announced positive new data from two global Phase 3 studies, BALATON and COMINO, evaluating Vabysmo (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion at 24 weeks. The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains. Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness. The safety profile of Vabysmo was consistent with previous trials. 

  • The CDC recommends patients and health-care providers immediately discontinue using EzriCare artificial tears pending additional guidance from CDC and the FDA. The CDC issued a Health Alert Network Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states. Patients reported more than 10 different brands of artificial tears, and some patients used multiple brands. The majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles. CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states. Read the full statement here.

  • Regeneron Pharmaceuticals announced the FDA approved EYLEA (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP). Following this first pediatric approval, EYLEA is now indicated to treat five retinal conditions caused by ocular angiogenesis. The FDA approval is supported by data from two randomized global Phase 3 trials — FIREFLEYE (N=113) and BUTTERFLEYE (N=120) — investigating EYLEA 0.4 mg vs laser photocoagulation (laser) in infants with ROP. In both trials, approximately 80% of EYLEA-treated infants achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age.

 

  • The FDA accepted the new drug application (NDA) from Aldeyra Therapeutics for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee Act date of Nov. 23, 2023. The NDA is supported by previously announced safety and efficacy results from five clinical trials encompassing data for ocular dryness symptom score, ocular redness, Schirmer test and Schirmer test ≥10 mm responder analysis. 

 

  • Endogena Therapeutics announced the FDA designated the investigation of EA-2353 for the treatment of retinitis pigmentosa (RP) as a Fast Track development program. EA-2353 takes a novel, small-molecule approach and selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and can potentially preserve or restore visual function. A Phase 1/2a dose-escalation study is currently being conducted to examine the safety, tolerability and preliminary efficacy of EA-2353 administered by intravitreal injection in patients with RP.

 

  • Orbis International announced a renewed partnership with HOYA Vision Care, which will commit its support over the next 3 years to improve health through vision for all. The support will focus on helping school children get access to eye care in low- to middle-income countries and on training physicians around the world through Cybersight, Orbis's telemedicine and e-learning platform. Over the next 3 years, HOYA's contribution will enable Orbis to screen more than 500,000 children and provide more than 15,000 eyeglasses as part of the REACH (Refractive Error Among Children) program in India. HOYA will also work with Orbis to support Vision Centers in India, which make eye care accessible in rural communities. 

 

  • Atsena Therapeutics announced positive interim data from the ongoing Phase 1/2 clinical trial of ATSN-101 will be presented at the 46th Annual Macula Society Meeting, Feb. 15-18, in Miami. This is an encore presentation of data that was presented as a late-breaker at the AAO 2022 annual meeting. ATSN-101, Atsena’s lead investigational gene therapy product, is being evaluated in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). LCA1 is a monogenic eye disease that disrupts the function of the retina and results in early and severe vision impairment or blindness.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.