Recent developments in ocular therapeutics highlight advancements in the treatment of dry eye disease (DED), age-related macular degeneration (AMD), and myopia. These updates span from new drug application resubmissions to clinical trial progress and innovative treatment modalities.
Reproxalap NDA Resubmitted for Dry Eye Disease
Aldeyra Therapeutics has announced the resubmission of its New Drug Application (NDA) to the FDA for reproxalap, a topical ocular drug candidate aimed at treating the signs and symptoms of dry eye disease (DED). The resubmission includes data demonstrating acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing symptoms in a field trial, and acute reduction of ocular redness in chamber trials. The FDA had requested additional positive results from a completed DED symptom trial following their review of the initial NDA.
Aviceda Therapeutics Completes Enrollment for AVD-104 in Geographic Atrophy
Aviceda Therapeutics has completed enrollment in its Phase 2b SIGLEC study, which is evaluating the safety and efficacy of AVD-104 for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). AVD-104 is described as an optimized intravitreal glycomimetic nanoparticle designed to enhance the safety and efficacy of GA treatment. Its mechanism of action involves inhibiting macrophage and complement cascade amplification.
MiYOSMART Lens Shows Long-Term Myopia Control
A clinical study presented by HOYA Vision Care at the 60th International Myopia Conference 2024 in Sanya, China, revealed that a significant number of patients continued to use MiYOSMART spectacle lenses for as long as 8 years. The study evaluated the long-term myopia control effect and user experience associated with these lenses, which feature Defocus Incorporated Multiple Segments (DIMS) technology.
Bausch + Lomb Launches Digital Marketplace
Bausch + Lomb has launched Opal, a digital e-commerce marketplace in the US designed to streamline the ordering process for eye care practices and their patients. The platform will initially focus on Bausch + Lomb contact lenses, with plans to add other over-the-counter (OTC) products in the future.
Ocular Therapeutix Accelerates Axpaxli Trial for Wet AMD
Ocular Therapeutix has announced an acceleration of timelines for its SOL-1 Phase 3 registrational clinical trial of Axpaxli for wet age-related macular degeneration (AMD). The company now expects full enrollment of 300 patients by the end of 2024, with topline data anticipated in the fourth quarter of 2025. This revised timeline is ahead of the previously projected completion of enrollment by the end of the first quarter of 2025.
NovaSight's CureSight Device for Amblyopia Treatment
NovaSight reported results from a clinical study of its CureSight device, which showed significantly greater improvements in visual acuity (VA) compared to traditional patching for amblyopia. The study, published in the American Journal of Ophthalmology, evaluated the binocular eye-tracking device's effectiveness in treating amblyopia.
