EyeWorld Weekly, September 23, 2022

EyeWorld Weekly, September 23, 2022

EyeWorld Weekly

September 23, 2022 • Volume 28, Number 37

Positive topline data for travoprost implant

Glaukos announced positive topline data from two Phase 3 pivotal trials for its iDose TR travoprost implant. According to the company’s press release, primary efficacy endpoints were met with favorable tolerability and safety profiles. The company said that 93% of participants in the slow-release iDose TR trial remained well controlled on the same or fewer IOP-lowering drops at 12 months after a single iDose TR implant; 81% were drop free. The company reported that iDose TR is implanted in a micro-invasive procedure and contains a “novel formulation of travoprost” that is released over time. iDose TR is designed to be removed once spent with the possibility for replacement. Glaukos stated that with the results from these Phase 3 trials, it plans to submit an NDA to the FDA for the slow-release iDose TR.

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Enrollment complete for dry AMD interventional trial

Pixium Vision announced that it completed enrollment in an interventional, pivotal trial for patients with atrophic dry AMD. The trial enrolled 38 patients (beginning in December 2020) with the aim of confirming safety and clinical benefits of the Prima System, which is a subretinal photovoltaic wireless implant for patients who have lost sight due to outer retinal degeneration. There is a wait list, according to the company, for additional patients to potentially enter the trial. A readout from the trial is expected by the end of 2023, the company’s press release noted.

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European Commission approves new treatment for wet AMD and DME

Roche announced that Vabysmo (faricimab), for treatment of wet AMD and visual impairment due to DME, was approved by the European Commission. Phase 3 data, the company’s press release reported, showed that patients achieved similar outcomes with Vabysmo every 4 months compared to aflibercept every 2 months. Patients treated with Vabysmo received up to 33% fewer median number of injections compared to aflibercept. According to the company’s press release, Vabysmo is the only injectable eye therapy approved in Europe with Phase 3 data supporting a treatment interval of up to 4 months.

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Interim results for first-in-human trial with new glaucoma implant

Ciliatech provided interim results from a 12-month follow-up study that evaluated its glaucoma implant CID (cilio-scleral inter-positioning device). According to the company’s press release, the study included 42 patients with POAG who received the device, designed to lower IOP, without entering the anterior chamber or creating subconjunctival filtration. More specifically, the company stated that the device is embedded between the ciliary body and the sclera, “unlocking the natural uveoscleral pathway.” The company noted that it expects publication of full results in peer review in the first quarter of 2023. The company hopes to obtain the CE mark and FDA approval by 2024 or 2025, according to the press release.

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Three non-antibiotic drugs identified to treat ocular infection

Researchers at Wayne State University School of Medicine have identified three non-antibiotic drugs that could be used to treat bacterial infections in the eye, a news report from the university stated. The researchers specifically looked at treatment options for Staph. aureus endophthalmitis, which has become increasingly antibiotic resistant, and current antibiotic treatments don’t address associated inflammation, according to the report. In the paper investigators published in iScience, they used a drug repurposing approach to help predict three non-antibiotics—Dequalinium chloride (DC), Clofilium tosylate (CT), and Glybenclamide (Glb)—that they said “reversed the [Staph. aureus] infection signatures.” In human retinal cells infected with sensitive and resistant strains of Staph. aureus, these drugs showed anti-inflammatory properties, and intravitreal injection of the drugs into mouse eyes infected with the bacteria also showed reduced inflammation and reduced bacterial load with DC and CT. The study reported that the drugs worked well with adjunct vancomycin use. The university’s news article reported that the team is investigating the antimicrobial and anti-inflammatory mechanisms of these drugs and is testing against other bacterial pathogens.

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ASCRS news and events

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Research highlights

  • Intraoperative OCT to detect high vault of an implantable collamer lens (ICL), providing guidance on adjustment during implantation, was assessed in a prospective, single-arm observational study published in the Journal of Cataract & Refractive Surgery. The study included 25 eyes of 25 consecutive patients that showed high intraoperative vault. The central ICL vault was measured intraoperatively and with a standard surgical microscope, as well as postop with an SS-OCT device at 4 hours, 1 day, and 1 month. According to the paper, the mean vault value intraoperatively was 1147.88±188.36 μm; this changed to 739.76±194.97 μm after lens rotation to a vertical or oblique position. The authors concluded that “intraoperative adjustment of ICL vault by lens rotation using intraoperative OCT was an effective procedure to obtain optimal vault.” 
  • While the LiGHT trial showed SLT was a clinical and cost-effective first-line therapy for patients with open-angle glaucoma (OAG) and ocular hypertension (OHT) at 3 years, a more recent paper published in the journal Ophthalmology reported on the health-related quality of life and clinical effectiveness of initial SLT treatment compared to drops after 6 years. This prospective, multicenter, randomized controlled trial, after the initial 3 years, allowed patients in the SLT arm to receive a third SLT, if needed, and patients in the drops arm were allowed to receive SLT either as a switch or an escalation of their treatment. For the 6-year trial, 524 participants completed follow-up (82.8% of those who entered the extension phase and 73% of those in the initial randomization). The research found that the SLT arm had 69.8% of eyes remaining at or below target IOP without additional medical or surgical intervention. More eyes in the drops arm exhibited progression. As for trabeculectomy, it was required in 32 eyes in the drops arm compared to 13 in the SLT arm. There were also more cataract surgeries in the drops arm. The authors concluded that “SLT is a safe treatment for OAG and OHT, providing better long-term disease control than initial drop therapy, with reduced need for incisional glaucoma and cataract surgery over 6 years.”

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Product news

  • Coherus BioSciences announced that October 3 would be the commercial launch of CIMERLI (ranibizumab-eqrn), a biosimilar to Lucentis (ranibizumab, Genentech). 
  • Centricity Vision is introducing a new handpiece for the Zepto IOL Positioning System at the American Academy of Ophthalmology Annual Meeting. 
  • BVI received certification for its IOL portfolio under the European Medical Device Regulation.

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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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