AMD

i-Lumen Scientific randomly assigned its first US patient in the sham-controlled i-SIGHT2 pivotal study of its investigational, noninvasive bioelectric AMD device at Texas Retina Associates.

The resubmission is considered a Class 1 submission and has a current PDUFA target action date of July 29, 2026.

The study, conducted through the OHDSI network, analyzed records from 227,971 new users of semaglutide.

The resubmission follows a successful appeal by the company with the Office of New Drugs (OND).

The FDA's OND found substantial evidence of effectiveness for bevacizumab-vikg in nAMD, clearing the way for a BLA resubmission in June 2026 and a decision expected within 60 days.

AMD affects approximately 28 million people in the US and is a leading cause of vision loss among older adults.

Avacincaptad pegol may help preserve driving-related vision in geographic atrophy, but post hoc data did not reach statistical significance.

The study, published in PLoS Genetics, examined how glucose metabolism affects gene expression in light-sensing photoreceptors.

Researchers noted growing evidence supporting an additional role for B vitamins.

The analysis included 12,183,254 patients, with 304,823 identified as smokers and 11,878,431 as non-smokers.

Phase 2 ArMaDa data show statistically significant 31% reduction in geographic atrophy lesion growth with OCU410 at 12 months, with a favorable safety profile supporting phase 3 development.

Metformin, a common diabetes medication, may be associated with less development of intermediate age-related macular degeneration (AMD).

In recent months, developments have ranged from regulatory setbacks to real-world data releases.

The prospective observational study is being conducted across 18 countries.

The goal of the study was to investigate the natural history of macular tissue preservation in GA by evaluating the relationship between the MTII and BCVA over time.

A total of 38 patients were included in the study. All underwent implantation of the PRIMA retinal prosthetic chip with the goal of restoring vision.

Understanding AMD pathophysiology through nutrition has helped shape the disease’s detection and management.

Knowing what’s on the market for AMD and GA aids in preserving vision.

The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials showing efficacy, according to the company.

Additionally, the FDA approved a monthly dosing option for some patients who may benefit from resuming this schedule across approved indications.

Outlook Therapeutics seeks FDA clarity on ONS-5010 after a complete response letter, aiming to address efficacy concerns for wet AMD treatment.

FDA issues a complete response letter to Outlook Therapeutics for ONS-5010, citing insufficient evidence of effectiveness for wet AMD treatment.

Nutrition is not ancillary to eye health—it is foundational.

Diagnostic tools, therapeutic innovations such as anti-vascular endothelial growth factor (VEGF) therapies, and supportive technologies to manage vision loss form the myopic macular degeneration market.

Additionally, the company is exploring different strategic alternative to advance its suprachoroidal space (SCS) platform and drug development pipeline.