Articles related to Ophthalmology

The FDA classified a recall of 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief as a Class II event after the manufacturer identified sterility concerns and potential contamination affecting a single lot.

Systemic nicotinamide exposure was associated with a lower risk of conversion from ocular hypertension to primary open-angle glaucoma in a large real-world cohort. Patients receiving nicotinamide also had lower rates of topical therapy initiation and laser trabeculoplasty, although the study did not establish causality.

Genetic testing identifies causative variants in approximately 65% to 70% of suspected inherited retinal disease cases and may shorten diagnostic delays. Advances in sequencing technologies and expanding testing access continue to shape retinal disease evaluation and counseling.

CMS has proposed 2027 ambulatory surgery center payment changes that would reduce reimbursement for several high-volume ophthalmic procedures, including cataract surgery. The proposal remains under review as ophthalmology organizations evaluate potential impacts on practice operations and patient access.

CMS proposed 2027 Physician Fee Schedule changes that would reduce reimbursement for certain same-day evaluation and management services performed with procedures. Ophthalmology organizations warned the changes could affect glaucoma treatment workflows, although the proposal remains under review.

The FDA accepted Belite Bio’s NDA for tinlarebant in Stargardt disease type 1 and granted Priority Review. In the phase 3 DRAGON trial, treatment reduced atrophic retinal lesion growth by 35.7% compared with placebo, with regulatory review ongoing.