• Tags: retina
FDA grants RMAT designation to 4DMT for DME gene therapy
Pipeline

FDA grants RMAT designation to 4DMT for DME gene therapy

4D-150 provides a multi-year sustained delivery of anti-VEGF from the retina via a single, low-dose IVT delivery—potentially reducing the need for frequent bolus injections.
OcuSciences receives FDA clearance for retinal health assessment tool
Products

OcuSciences receives FDA clearance for retinal health assessment tool

The OcuMet Beacon, a confocal scanning ophthalmoscope, is indicated to provide a rapid, pain-free, and noninvasive imaging evaluation for earlier disease detection.
New technology targets photoreceptor cells to create a novel color
Research

New technology targets photoreceptor cells to create a novel color

Oz prototype system allows for perception of “olo,” a blue-green color not visible in natural vision.
Smoking among factors linked to retinal vessel trait changes
Research

Smoking among factors linked to retinal vessel trait changes

Association with larger retinal arteriolar and venular size may have important implications for ocular health.
Topcon names former Genentech exec as chief medical officer
Business

Topcon names former Genentech exec as chief medical officer

Daniela Ferrara, MD, PhD’s role involves establishing retinal imaging as a first-line tool for both eyecare and the screening and management of complex systemic diseases.
Study connects HDL levels to AMD development
Research

Study connects HDL levels to AMD development

Key finding: A U-shaped relationship between low and high HDL and increased risk of AMD.
Safety and efficacy data supports Vista 1-Step vitrectomy probe
Research

Safety and efficacy data supports Vista 1-Step vitrectomy probe

A total of 86% of pseudophakic patients reported a complete resolution of symptoms by postop month 3 following limited vitreous removal procedure.
BVI Medical and Neurotech name new CCOs
Business

BVI Medical and Neurotech name new CCOs

With over 20 years of executive leadership experience each, Andrew Chang and Beth Marsh will lead commercialization efforts for their respective companies’ upcoming product launches.
Voiant acquires AI-based ophthalmic image analysis startup Voxeleron
Business

Voiant acquires AI-based ophthalmic image analysis startup Voxeleron

Software and clinical trial expertise to combine into an AI-based integrated platform for retinal and corneal imaging, with a goal of expedited patient treatment delivery.
FDA accepts Regeneron's EYLEA HD sBLA for priority review
Products

FDA accepts Regeneron's EYLEA HD sBLA for priority review

Agency sets target action date of Aug. 19 to consider a new indication for macular edema following RVO and expanded monthly dosing.
Phase 3 enrollment concludes for Oculis' DME eye drop program
Pipeline

Phase 3 enrollment concludes for Oculis' DME eye drop program

Topline data readout expected Q2 2026 as lead candidate OCS-01 has the potential to become the first noninvasive eye drop indicated to treat this retinal disease.
Settlement paves way for US commercialization of Eylea biosimilar
Products

Settlement paves way for US commercialization of Eylea biosimilar

Biocon Biologic’s YESAFILI (aflibercept-jbvf) now expected to launch in H2 2026 after dismissal of Regeneron’s patent infringement lawsuits.
Are uveitis patients at an increased risk for complications post-cataract surgery?
Research

Are uveitis patients at an increased risk for complications post-cataract surgery?

Postoperative complications varied based on the uveitis subtype.
FDA grants RMAT designation to Atsena's XLRS gene therapy
Pipeline

FDA grants RMAT designation to Atsena's XLRS gene therapy

This marks ATSN-201’s fourth designation in the FDA’s expedited drug development program, propelling it one step closer to becoming the first approved treatment for this IRD.
Do you need to treat subretinal fluid in AMD?
Research

Do you need to treat subretinal fluid in AMD?

Review outlines a proposed algorithm for evaluating subretinal fluid in nAMD patients.
Pykus concludes study enrollment for post-RD surgery retinal sealant
Pipeline

Pykus concludes study enrollment for post-RD surgery retinal sealant

Biodegradable, focal hydrogel retinal sealant could replace the need for medical gases or silicone oil, eliminate face-down positioning, and accelerate visual recovery.
Opus Genetics reports first-in-human trial data on LCA gene therapy
Pipeline

Opus Genetics reports first-in-human trial data on LCA gene therapy

One-month findings from the first of three pediatric dosings indicate a clinically meaningful improvement in vision following just one dosing.
FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD
Pipeline

FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD

With a PDUFA date of Aug. 27, ONS-5010 (LYTENAVA) could become the first FDA-approved bevacizumab formulation targeting this retinal disease.
Hormones may play key role in DR risk among diabetes patients
Research

Hormones may play key role in DR risk among diabetes patients

Surprising findings reveal how sex hormones may secretly influence the risk for diabetic retinopathy.
Chronic stress linked to increased AMD risk
Research

Chronic stress linked to increased AMD risk

Study joins a growing body of evidence that chronic stress is an important risk factor for ocular diseases.