June 17, 2025

FDA Clears IND Amendment to Initiate Phase 2/3 Trial of Ocugen's OCU410ST for Stargardt Disease

The phase 2/3 clinical trial for OCU410ST, a modifier gene therapy candidate, will enroll 51 participants diagnosed with Stargardt disease. The primary objective of the trial is to evaluate the reduction in atrophic lesion size.

Ophthalmology Management

June 17, 2025

Aldeyra Therapeutics Resubmits Reproxalap NDA for the Treatment of DED

Per FDA agreement, the only new clinical data included in the resubmitted new drug application were from the recently completed dry eye chamber trial, which achieved the primary endpoint, according to the company.

Ophthalmology Management

June 13, 2025

FDA Approves Amneal's Prednisolone Acetate Ophthalmic Suspension

Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation.

Ophthalmology Management

June 05, 2025

Gene Therapy for Stargardt Advances to Trial

VeonGen announces new name and progress in its VG801 clinical program, which targets genetic mutations linked to Stargardt disease.

Retinal Physician

June 03, 2025

Presbyopia Drop Gets FDA New Drug Application Approval

The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026, for the drug.

Optometric Management

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.

Retinal Physician

May 09, 2025

West Virginia Gains Scope of Practice Expansion

West Virginia passes a law enabling optometrists to use ophthalmic lasers, providing essential eye care services for patients, especially in rural areas, and increasing access for Medicare beneficiaries. Source: Optometric Management

Optometric Management

August 27, 2024

PCPs Play Important Role in Glaucoma Screening

“Recommendations from trusted primary providers have likely kept millions of individuals from becoming blind.”

Conexiant

February 13, 2025

FDA Approves Extended Label for Avacincaptad Pegol

The new label removes limitations on the duration of dosing.

Conexiant