- FDA grants IND for Stargardt gene therapy
- Phase 2 clinical trial evaluates oral nicotinamide and pyruvate effect on visual function
- First ophthalmic formulation of bevacizumab moves toward FDA BLA submission
- Positive results for faricimab as an investigational treatment for wet AMD, DME
- Eye scans and AI predict risk of heart attack
- ASCRS news and events
January 28, 2022 • Volume 28, Number 4
FDA grants IND for Stargardt gene therapy
Nanoscope Therapeutics announced that it received IND clearance from the FDA for a Phase 2 trial of multi-characteristic opsin (MCO-010), described by the company as an ambient light activatable optogenetic monotherapy that could restore vision for patients with Stargardt disease. The Phase 2 trial is expected to begin this year. The company is already conducting a Phase 2b study with this therapy in patients with retinitis pigmentosa.
Phase 2 clinical trial evaluates oral nicotinamide and pyruvate effect on visual function
A Phase 2 clinical trial published in JAMA Ophthalmology sought to determine the effect of oral nicotinamide and pyruvate on retinal ganglion cell function for patients with progressing glaucoma. The authors wrote in the paper that preclinical research suggests that this drug combination enhances retinal ganglion cell survival in an animal model of glaucoma. There wasn’t, prior to this study, enough information about its effect in a clinical setting. Thirty-two participants (of 42 enrolled) completed the study, 22 of whom received the intervention and 12 of whom received placebo. The authors noted a significantly higher number of improved visual field test locations in the group treated with oral nicotinamide and pyruvate (15 vs. 7, respectively). There were no serious adverse events in the study, which had a mean follow-up time of 2.2 months. The authors concluded that this combination could result in a short-term improvement in visual function and suggested further study of the drugs’ utility in slowing glaucoma progression.
First ophthalmic formulation of bevacizumab moves toward FDA BLA submission
Outlook Therapeutics announced that within the first quarter of this year it plans to submit a Biologic License Application (BLA) to the FDA for ONS-5010/LYTENAVA, which would be the first ophthalmic formulation of bevacizumab for the treatment of wet AMD. If approved the company also stated that it would file a supplementary application to provide the product in a pre-filled, silicone oil-free syringe. The company is currently conducting a study comparing the safety of ONS-5010 in vials vs. pre-filled syringes.
Positive results for faricimab as an investigational treatment for wet AMD, DME
Genentech announced the publication of two papers in The Lancet with 1-year results from its four pivotal Phase 3 studies of faricimab, a bispecific antibody being investigated as a treatment for wet AMD and DME. According to the company, all four studies met their primary endpoints with patients in faricimab treatment groups going up to 4 months between treatments. Up to half of patients treated with faricimab were able to go 4 months between treatments and about 75% could go at least 3 months. Faricimab also achieved non-inferiority in terms of visual gains compared to aflibercept, which was dosed every 2 months. The company stated that, if approved, faricimab would be the first bispecific antibody for the eye. It targets and inhibits angiopoietin-2 and VEGF-A, which the company stated has complementary effects of stabilizing vessels, thus reducing vessel leakage and inflammation rather than just inhibiting the VEGF-A pathway alone. The FDA and European Medicines Agency are evaluating faricimab for treatment of wet AMD and DME.
Eye scans and AI predict risk of heart attack
The University of Leeds led the development of an artificial intelligence (AI) system that could read retinal scans and predict heart attack risk within the following year. According to a news article from the university, the AI system, which analyzed retinal and cardiac scans of more than 5,000 people, was 70–80% accurate in its predictions. The team thinks such a system could be used to identify and refer at-risk patients for a more thorough cardiovascular exam. The research was published in the journal Nature Machine Intelligence.
ASCRS news and events
- 2022 ASCRS Annual Meeting: Browse the recently released Preview Program for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022. There is also an open call for complicated case video submissions.
- ASCRS Winter Symposium: Registration is open for the Winter Symposium in Park City, Utah, February 10–12. The meeting focuses on innovative techniques and controversies in anterior segment ophthalmology.
- Beyond 20/20: Beyond 20/20: An ASCRS Series in Modern Refractive Surgery and Presbyopia Therapy is a new, four-part educational series sponsored by the Refractive Clinical Committee that features CME and non-CME components. Learn more about the series and register here.
- Eyecelerator@ASCRS: Eyecelerator@ASCRS is welcoming the Winning Pitch Challenge to its program, taking place April 21 ahead of the ASCRS Annual Meeting in Washington, D.C. The Winning Pitch Challenge supports physician entrepreneurs and is accepting submissions now. Learn more about the challenge, the submission process, and deadlines here.
Research highlights
- A study published in the British Journal of Ophthalmology sought to investigate the difference in adhesion and rebubbling rates that could be associated with eye bank-prepared DMEK tissue and surgeon-prepared tissue. This laboratory and clinical retrospective comparative interventional case series evaluated adhesion force and elastic modulus measured in an ex vivo laboratory setting with atomic force microscopy. Rebubbling rates were recorded for clinical study. The two preparations showed no difference in endothelial cell viability, but the surgeon-prepared DMEK grafts showed significantly higher elastic modulus and adhesion force compared to the eye bank-prepared, prestripped, and preloaded tissues. Rebubbling rates were 48%, 40%, and 15% in preloaded, prestripped, and surgeon-stripped preparations, respectively. The authors wrote that rebubbling rates were significantly associated with combined cataract surgery and time from harvesting graft until surgery.
- A single-site, prospective, single-arm study evaluated the visual outcomes and quality of vision in patients receiving the AcrySof IQ Vivity non-diffractive IOL (Alcon) with surgery targeting slight myopia (–0.75 D) in the non-dominant eye. At 3 months postop, 29 of 33 patients (88%) had binocular uncorrected near visual acuity of 0.2 logMAR or better. The authors reported 25 of 33 eyes (76%) having binocular distance corrected visual acuity of 0.2 logMAR or better at all three tested distances. Patient satisfaction with vision at all distances was high with a high level of spectacle independence reported compared to those who had also received Vivity without the mild myopia in the non-dominant eye. The authors reported a higher level of visual disturbances than previously reported with this lens but stated that these were not correlated with the monovision. This paper is published in the journal Clinical Ophthalmology.
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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