- Results from Phase 1 clinical trial of intranasal glaucoma drug
- Phase 3 clinical trial of new ophthalmic corticosteroid nanoemulsion
- Pharmaceutical company expands gene therapy pipeline
- Companies enter agreement to develop next-generation decision support software
- Study: Association between caffeine intake and glaucoma
June 11, 2021 • Volume 27, Number 23
Results from Phase 1 clinical trial of intranasal glaucoma drug
Noveome Biotherapeutics announced the preliminary results from its Phase 1 open-label clinical trial of intranasally delivered ST266 for glaucoma suspects. According to the company’s press release, ST266 is a cell-free platform biologic containing proteins and growth factors involved in cellular healing. This Phase 1 trial was designed to assess safety of the investigational compound in glaucoma suspects who did not have optic nerve damage. One cohort received a 200 µL dose daily for 14 days, alternating nostril administration, while another group followed the same dose schedule with 400 µL. A third group administered 200 µL to each nostril daily for 28 days. There were no drug-related serious adverse events and preliminary safety assessments of various metrics were normal, according to the company.
Phase 3 clinical trial of new ophthalmic corticosteroid nanoemulsion
Salvant announced completion of its Phase 3 clinical trial of a new ophthalmic corticosteroid designed to have better absorption and application for treatment of ocular inflammation and pain after cataract surgery. The multicenter U.S. study enrolled about 400 patients. The company’s press release described the investigational corticosteroid as being classified as “superpotent” and a nanoemulsion that has advantages of increased tolerability, patient comfort, and other features.
Pharmaceutical company expands gene therapy pipeline
Oyster Point Pharma announced expansion of its pipeline to include Enriched Tear Film Gene Therapy as well as proof-of-concept in vivo results of its gene therapy candidate, OC-101. According to the company’s press release, OC-101 is a varenicline nasal spray that could play a role in the company’s Enriched Tear Film Gene Therapy category, which delivers target genes to lacrimal gland cells through intralacrimal gland injection in order to produce the protein, enzyme, or other intended therapeutic gene product. The in vivo OC-101 proof-of-concept study delivered the human nerve growth factor (hNGF) gene to the intralacrimal gland and resulted in statistically significant levels of hNGF protein expression in a rabbit model, the company’s press release reported. The company plans to continue studying this candidate as a possible therapy for stage 2 and stage 3 neurotrophic keratopathy.
Companies enter agreement to develop next-generation decision support software
Bausch + Lomb announced in a press release that it entered into an agreement with Lochan to develop the next-generation eyeTELLIGENCE clinical decision support software. According to Bausch + Lomb, this cloud-based digital platform is designed to maximize data use and improve practice efficiency. It’s currently available with the Stellaris Elite Vision Enhancement System. The next-generation software for the technology is expected in 2022.
Study: Association between caffeine intake and glaucoma
Research announced by New York Eye and Ear Infirmary of Mount Sinai found consuming large amounts of caffeine daily could increase the risk of developing glaucoma in people who have a genetic predisposition. The multicenter study published in the journal Ophthalmology is, according to the press release, the first to demonstrate a dietary-genetic interaction in glaucoma. The research involved data from the U.K. Biobank, which included more than 120,000 participants (39–73 years old) between 2006–2010. In the analysis, caffeine intake was not associated with increased glaucoma risk or higher IOP overall, but among participants who had a strong genetic predisposition for higher IOP, there was an association. Specifically, the press release noted consumption of more than 480 milligrams daily (about four cups of coffee) as being associated with higher IOP, and consumption of 321 milligrams daily (about three cups of coffee) in the group with a genetic predisposition was associated with a nearly 4 times higher prevalence of glaucoma compared to those who had lower caffeine intake and a low genetic risk score.
Research highlights
- Researchers conducted a retrospective chart review to evaluate the incidence of corneal endothelial failure and its risk factors after phaco in patients with Fuchs endothelial corneal dystrophy. The chart review included 2,873 patients who had cataract surgery with IOL implantation in Bangkok, Thailand, between January 2007 and December 2019. Of these, 94 patients with Fuchs were included in the analysis. Nine patients (9.57%) developed corneal endothelial failure in the follow-up period (mean 3.2 years). Intraoperative complications during phaco were identified as having a significant association with endothelial failure, but there was no significant association when it came to age, gender, underlying diseases, cataract grade, or other parameters. With that, the researchers concluded that intraoperative complications should be considered an important risk factor for endothelial failure in this patient population. The research is published in the journal Clinical Ophthalmology.
- An ab externo microshunt vs. trabeculectomy in patients with POAG was compared in research published in the journal Ophthalmology. This 2-year, prospective, randomized, multicenter, noninferiority study included patients 40–85 years old with an IOP between 15–40 mm Hg with mild to severe POAG that was not controlled on maximum medical therapy. Patients either had standalone microshunt (n=395) or trabeculectomy (n=132), both with mitomycin-C. After 1 year postop, trabeculectomy was found to be more successful compared to the microshunt (more patients with trabeculectomy achieved a 20% or more reduction in IOP). Reduction in glaucoma medications was also greater in the trabeculectomy group.
Product news
- Avellino Lab announced availability in the U.S. of its AvaGen genetic test for keratoconus-related genes and gene variants.
- Johnson & Johnson Vision announced the launch of the TECNIS Eyhance Toric II and TECNIS Simplicity Delivery System in Europe.
- EyeYon Medical received the CE mark for EndoArt, which the company described as a synthetic implant that replaces human endothelium for patients with chronic corneal edema who are waiting for a human donor tissue transplant.
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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