JAN 15, 2021
Comprehensive Ophthalmology, Cornea/External Disease, Glaucoma, Retina/Vitreous
A weekly roundup of ophthalmic news from around the web.
Gemini Therapeutics’ new dry AMD drug has won FDA fast-track designation, announced the company this week. Their drug GEM103—a recombinant, human complement factor H—is being assessed for its ability to slow disease progression and address multiple AMD pathobiologies associated with complement dysregulation. A phase 3a study is already underway to evaluate GEM103 for geographic atrophy secondary to dry AMD. Gemini Therapeutics
Glaukos is reporting favorable results from 2 recent glaucoma trials. One trial evaluating the sustained-release travoprost implant iDose TR showed “substantial” IOP reductions at the 24-month mark that was similar to twice-daily timolol. The company is also reporting positive outcomes for the latest iteration of the iStent device: At 1 year, the iStent infinite lowered mean diurnal IOP in people with open-angle glaucoma. Target dates for FDA approval are late 2021 for iStent infinite and 2023 for iDose TR. Glaukos
Exciting news from Israel: CorNeat Vision’s first patient with their artificial cornea has regained vision. Bypassing the need for donor tissue, the CorNeat KPro is a patented synthetic cornea that integrates beneath the conjunctiva and is attached to the eye via 3 nondegradable sutures—a procedure the company claims is relatively simple. The company began clinical trials earlier this year and hopes to launch the product in 2022. Watch as the trial’s first patient, a 78-year-old man who lost vision due to edema and background disease, begins to read text and recognize his family. CorNeat Vision
Notal Vision launched their first U.S. study employing their at-home OCT platform for patients with wet AMD. The longitudinal study will assess 15 patients’ ability to perform sequential daily self-imaging of their eyes with the Notal Home OCT device for 90 days while undergoing standard anti-VEGF therapy. Volume scans are then transmitted to and analyzed by an AI-based system that assesses intra- and subretinal fluid. “Remote OCT monitoring of wet AMD patients has the potential to personalize anti-VEGF treatment and improve outcomes while minimizing treatment burden by reducing the number of office visits,” said Jeffrey Heier, MD, one of the study’s principal investigators. The system received breakthrough designation in 2018. Notal Vision
Reproxalap shows promise for signs and symptoms of dry eye, according to preliminary phase 3 results. Findings from a 23-subject run-in cohort revealed that reproxalap was statistically superior to vehicle for ocular dryness and ocular discomfort among participants exposed to a dry eye chamber. Symptoms and redness improved within minutes after administration. Aldeyra Therapeutics will begin enrolling the main cohort in February 2021 and has plans to launch a second phase 3 trial. Aldeyra Therapeutics