EyeWorld Weekly, June 18, 2021

EyeWorld Weekly, June 18, 2021

EyeWorld Weekly

June 18, 2021 • Volume 27, Number 24

Investigational gene therapy for choroideremia does not meet study endpoints

Biogen announced topline results from its Phase 3 STAR study of an investigational gene therapy (timrepigene emparvovec) for choroideremia. Neither primary nor key secondary endpoints were met. According to the company’s press release, the study included 169 adult males with the genetic diagnosis of choroideremia, an inherited retinal disease. Timrepigene emparvovec was injected in the subretinal space and the primary endpoint was proportion of patients with improvement of at least 15 letters in BCVA from baseline. Investigators will finish evaluating the data set before confirming next steps for the development program of this investigational gene therapy, the company stated.

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Positive safety results in Phase 1/2a clinical trial of investigational drug for wet AMD

Clearside Biomedical announced safety results from its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) for patients with wet AMD. According to the company’s press release, the patients in cohort 1 (n=6) received the lowest planned dose (0.03 mg of CLS-AX), which was well tolerated with no serious adverse events and no drug-related treatment adverse events (no signs of inflammation, vasculitis, IOP issues, drug dispersion into the vitreous, etc.). With these safety results, the company stated that its research will advance to cohort 2, which will receive a higher dose of 0.1 mg CLS-AX. A third cohort will receive a 0.3 mg dose at a later date. The company’s press release described CLS-AX as a tyrosine kinase inhibitor, which is currently approved to treat renal cell cancer, that inhibits VEGF receptors-1, -2, and -3. The investigational compound is being delivered in the dose escalation study as a suprachoroidal injection.

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Patient enrollment complete for Phase 3 clinical trial of sustained-release travoprost implant

Glaukos announced completion of patient enrollment (1,150 participants across 89 clinical sites) in its FDA NDA Phase 3 clinical trial of iDose TR, a sustained-release travoprost implant. The study, according to the company’s press release, consists of two prospective, randomized, double-masked clinical trials that will compare safety and efficacy of one of two iDose TR models. Each model has a different travoprost release rate, which in the studies will be compared to topical timolol ophthalmic solution, 0.5%, dosed twice daily. The primary efficacy endpoint is non-inferiority to topical timolol over 3 months; safety will be evaluated up to 12 months. According to the company’s press release, the study is intended to support its targeted NDA submission, expected in 2022 with the hope of FDA approval in 2023.

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Two companies enter collaboration to develop, commercialize ocular surface disease therapies

Oyster Point Pharma announced its research collaboration with Adaptive Phage Therapeutics to develop and commercialize treatments for ocular surface disease. According to the company’s press release, Adaptive Phage Therapeutics has PhageBank technology, which includes bacteriophages that can be useful among emerging antimicrobial resistance. Leadership described this as having the potential to become the “first evergreen antimicrobials” to be used in ophthalmology against bacterial infections.

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ASCRS events

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Research highlights

  • A case report published in the journal Cornea described how a Gundersen flap removal followed by amniotic membrane transplantation was able to restore the ocular surface of a 57-year-old male patient who had a non-healing corneal ulcer. According to the paper, the ocular surface recovered postop and there was no evidence of limbal stem cell deficiency. His CDVA of 20/60 and improved ocular surface condition remained stable out to the last follow-up at 12 months postop. The authors reported that this case highlights the potential to restore a normal ocular surface after Gundersen flap surgery if the limbal epithelium is not removed during the procedure. 
  • Refractive prediction accuracy of the Haigis-L formula in eyes with extremely long axial lengths after LASIK (more than 29.0 mm) was compared to four other IOL power calculation formulas (Barrett True K No History, Shammas-PL, SRK-Tcorrected K, and the Holladay 2corrected K) in a retrospective case series published in the journal Eye. Twenty-nine eyes of 19 patients were included in the analysis. The Haigis-L was found to be accurate in refractive prediction in post-myopic LASIK eyes with extremely long axial lengths, but it was less accurate in corneas that were dubbed extremely flat (more than 35 D). The authors reported that SRK-Tcorrected K and Shammas-PL were more accurate than the other formulas in this group of eyes.

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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: 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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