2025 News Archive

2025

2024

Monday, April 28, 2025

Gold Nanoparticles Used to Stimulate Retinal Cells in Mice

A new approach could offer a potential treatment for AMD and other retinal disorders.

Monday, April 28, 2025

Biomarkers May Predict Ocular Cancer Risk

Study finds that protein markers in aqueous humor could help identify high-risk uveal melanomas.

Friday, April 25, 2025

Alcon Launches Unity Vitreoretinal Cataract System

According to Alcon, the systems feature many first-to-market technologies designed to deliver transformative surgical innovation for cataract and vitreoretinal surgery, including Unity 4D Phaco, HYPERVIT 30K and the advanced Unity Intelligent Fluidics system.

Thursday, April 24, 2025

FDA Rejects Extended Dosing Intervals for Eylea HD

The agency did not agree with Regeneron’s proposal to add dosing intervals greater than every 16 weeks, the maximum interval currently indicated for aflibercept 8 mg injections.

Thursday, April 17, 2025

FDA Reviews Eylea HD for RVO

The agency has initiated priority review of the anti-VEGF agent as a treatment for macular edema secondary to retinal vein occlusion.

Thursday, April 17, 2025

Research Grant Honors Prof. Tadayoni’s Legacy

Oculis and EURETINA will once again fund the Ramin Tadayoni Award, which supports innovation in retina. Applications for the prize are now open.

Wednesday, April 16, 2025

Biocon, Regeneron Reach Agreement on Eylea Biosimilar

The agreement clears the way for Yesafili, an FDA-approved aflibercept biosimilar, to be commercialized in the United States.

Wednesday, April 16, 2025

FDA Grants RMAT Status to Gene Therapy

Atsena Therapeutics received the designation for ATSN-201, a therapy intended to treat X-linked retinoschisis.

Friday, April 11, 2025

Outlook Resubmits BLA for ONS-5010

The FDA sets an August 2025 PDUFA target to review the application of ophthalmic bevacizumab for wet AMD.

Thursday, April 10, 2025

Oculis Completes Enrollment in DME Therapy Trials

Two studies in the company's phase 3 DIAMOND program are evaluating a novel eye drop for diabetic macular edema.

Tuesday, April 8, 2025

Opus Reports Early LCA5 Trial Data

Preliminary results in a pediatric patient who underwent gene therapy to treat a form of Leber congenital amaurosis show improved vision and no safety issues.

Thursday, April 3, 2025

Positive Results for UBX1325 in DME Trial

Unity Biotechnology reports that treatment with UBX1325 resulted in vision gains comparable to aflibercept at weeks 24 and 36 in a difficult-to-treat patient population.

Monday, March 31, 2025

Opthea Suspends ShORe, COAST Trials

Top-line data from the phase 3 trials of sozinibercept showed that the nAMD treatment failed to meet its primary BCVA endpoints in both studies.

Monday, March 24, 2025

Medicare Approves Expanded Reimbursement for Triesence

CMS will provide separate payment for the drug in surgical settings starting April 1.

Monday, March 24, 2025

Opthea Reports Topline Data from COAST Trial

The trial did not meet its primary endpoint of mean change in best-corrected visual acuity (BCVA) from baseline to week 52.

Thursday, March 20, 2025

Kalaris Closes Merger with AlloVir

The company will retain the Kalaris name, and will continue enrolling its phase 1 nAMD trial of TH103, a novel anti-VEGF agent.

Monday, March 17, 2025

FDA Approves Expanded Label for Iluvien

The implant is now approved as a treatment for chronic noninfectious uveitis affecting the posterior segment of the eye in addition to DME.

Thursday, March 13, 2025

Gene Therapy Granted Fast Track Designation

Atsena Therapeutics's ATSN-201 is aimed at treating X-linked retinoschisis, a rare inherited disease.

Tuesday, March 11, 2025

Harrow Executes Triesence Manufacturing Agreement

The 5-year plan should ensure continued production of the preservative-free corticosteroid, which was unavailable in the US between 2022 and 2024.

Friday, March 7, 2025

Optos Expands Retinal Imaging Database

The enhanced dataset will help clinicians detect and manage eye diseases at an earlier stage.

Thursday, March 6, 2025

Clearside Plans Pivotal Phase 3 Trials for CLS-AX

In a recent meeting with the FDA, the company confirmed key elements of the trials planned for its sustained-release TKI therapy.

Thursday, March 6, 2025

FDA Approves First Treatment for MacTel

Neurotech’s ocular insert Encelto aims to slow vision loss in patients with this degenerative retinal disease.

Tuesday, March 4, 2025

Adverum Initiates Phase 3 ARTEMIS Study

The pivotal trial is designed to evaluate the efficacy and safety of Ixo-vec, an investigational gene therapy, in patients with neovascular AMD.

Tuesday, March 4, 2025

Outlook Seeks FDA Approval of nAMD Treatment

The company has resubmitted its BLA for ONS-5010, an ophthalmic formulation of bevacizumab, with data from the recently completed NORSE EIGHT trial.

Tuesday, March 4, 2025

Opthea Publishes Phase 2b Wet AMD Data

The paper reports pre-specified and post hoc analyses of angiographic predictors of response to sozinibercept combination therapy with ranibizumab in treatment-naïve patients with wet AMD.

Friday, February 28, 2025

Prevent Blindness Declares March Workplace Eye Wellness Month

The goal of the annual observance is to provide employers and employees with important information to help keep eyes safe and healthy at work.

Thursday, February 27, 2025

Opthea Completes Drug Process Qualification

The campaign validates Ophthea's commercial-scale drug manufacturing process, in preparation for a potential BLA filing for sozinibercept in wet AMD.

Thursday, February 27, 2025

Zervimesine Passes Pre-defined Futility Analysis of Phase 2 Study

Masked analysis shows participants receiving oral zervimesine for at least 6 months experienced slower lesion growth than participants receiving placebo.

Monday, February 24, 2025

MeiraGTx Publishes Results From Study Treating Children With AIPL1-associated Severe Retinal Dystrophy

In this first-in-human interventional study, 4 legally blind children gained visual acuity following delivery of gene therapy.

Friday, February 21, 2025

Event Dedicated to Integrative Eye Health Scheduled

The Eye Health Summit, a new global patient-centered event dedicated to integrative eye health, will take place May 1-7 as a free hybrid event.

Friday, February 21, 2025

RetinalGenix Develops Remote Imaging Device

The company says the device will enable screenings for retinal diseases in various health care and retail settings.

Tuesday, February 18, 2025

Prevent Blindness Declares Second Annual ROP Awareness Week

The initiative, taking place February 24 to March 2, is intended to provide education and support for families of children with retinopathy of prematurity.

Tuesday, February 18, 2025

Opthea Provides Update on COAST Trial

COAST is a phase 3 pivotal trial investigating sozinibercept in combination with aflibercept as a treatment for wet AMD.

Tuesday, February 18, 2025

Opus Genetics Provides Update on Clinical Program

The first patient has been dosed in the pediatric cohort of the phase 1/2 trial of OPGx-LCA5, with initial data anticipated by Q3 2025.

Saturday, February 15, 2025

Optos Introduces New Imaging System

The next-generation MonacoPro system integrates ultrawidefield imaging with improved diagnostic support.

Thursday, February 13, 2025

Eylea HD Shows Positive Results in RVO Trial

The phase 3 QUASAR study finds the extended dosing intervals effective for macular edema secondary to retinal vein occlusion.

Thursday, February 13, 2025

Gene Therapy Trial Shows Reduced Injections for Wet AMD

4D Molecular Therapeutics recently reported 52-week data from a phase 2b study indicating that the therapy demonstrated stable vision outcomes and reduced treatment burden.

Thursday, February 13, 2025

FDA Approves Izervay Label Expansion

The update removes limitations on duration of dosing for the GA treatment.

Thursday, February 13, 2025

Gene Therapy for LHON Shows Sustained Vision Gains

Five-year data from the REFLECT trial of Lumevoq demonstrate long-term efficacy and safety.

Thursday, February 6, 2025

Foundation Fighting Blindness to Host Free Webinar on Gene Therapies for Inherited Retinal Diseases

The free, online event at 7 p.m. ET on March 13, will review several topics, including: Viral delivery systems, surgical techniques, current clinical trials and endpoints, inflammation management, and future directions.

Wednesday, February 5, 2025

EyePoint Reports Positive Results from DME Trial

Six-month data from the phase 2 VERONA trial shows Duravyu extended treatment intervals and improved vision for diabetic macular edema patients.

Tuesday, February 4, 2025

FDA Clears Susvimo for the Treatment of DME

Genentech’s refillable implant is the first continuous-delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema.

Monday, February 3, 2025

New Test Detects Parent-of-Origin in Hereditary Eye Cancer

Origin matters for this hereditary ocular cancer because researchers found that male and female copies of the mutation are associated with different disease trajectories, and so would likely influence physicians' treatment recommendations.

Monday, February 3, 2025

BVI Medical Launches EyeXchange Solutions Educational Platform for Ophthalmic Surgeons

EyeXchange Solutions connects experienced and emerging surgeons across cataract, glaucoma, and retina specialties to share insights, refine techniques, and address complex cases.

Thursday, January 30, 2025

Norlase Receives 510(k) Clearance for LYNX Pattern Scanning Laser Indirect Ophthalmoscope

Norlase has announced the immediate commercial launch and FDA 510(k) clearance and CE Mark for LYNX, the company’s pattern scanning laser indirect ophthalmoscope.

Thursday, January 30, 2025

AI Optics Receives FDA 510k Clearance for Sentinel Camera Handheld Retinal Imaging System

AI Optics' Sentinel Camera is a handheld retinal imaging system that captures high-quality images of the human eye, and is designed to be easy to use and support non-dilated imaging.

Thursday, January 30, 2025

PulseSight Therapeutics Initiates Clinical Plan of Transferrin Vectorized Therapy for Dry AMD and GA

PulseSight Therapeutics announced it has submitted a Clinical Trial Authorization to France's regulatory agency for PST-611, a first-in-class non-viral vectorized therapy for the treatment of dry age-related macular degeneration and geographic atrophy.

Thursday, January 30, 2025

Ocular Therapeutix Shares SOL-R Enrollment Progress, Next Steps for Axpaxli in Non-Proliferative Diabetic Retinopathy

Ocular Therapeutix has outlined the clinical progress across its registrational program for Axpaxli in wet age-related macular degeneration (wet AMD), plans to advance Axpaxli in non-proliferative diabetic retinopathy (NPDR), and the company’s strategic outlook for 2025 in its presentation at the 43rd Annual J.P. Morgan Healthcare Conference.

Thursday, January 30, 2025

Harrow and Cencora Partner to Launch Harrow Cares Program

According to Harrow, the Harrow Cares program ensures seamless enrollment, rapid access to therapy, and personalized support, enabling retina providers to confidently utilize Iheezo and Triesence in their practices.

Wednesday, January 22, 2025

MeiraGTx Receives Rare Pediatric Disease Designation from FDA

The designation is for the company's AAV8-RK-RetGC program for the treatment of patients with Leber congenital amaurosis due to GUCY2D mutations (LCA1). It makes the fourth Rare Pediatric Disease Designation MeiraGTx has received for inherited retinal diseases.

Tuesday, January 21, 2025

PentaVision

Retinal Physician

2025 News Archive

Recommendations