2023 in review: A review of FDA approvals in eye care this year
Eye care witnessed a transformative year with 11 FDA approvals. As the year concludes, there remains a robust pipeline of drugs, setting high expectations for continued advancements in ophthalmological care in 2024 and beyond.
Topline results from Ersa Phase 2a trial revealed by Tarsus
December 11th 2023TP-03 (lotilaner ophthalmic solution, 0.25%) was approved by the FDA in 2023 under the brand name Xdemvy for the treatment of Demodex blepharitis and is being evaluated as an investigational therapy for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites.
Aldeyra Therapeutics faces stock plunge and potential FDA setback for reproxalap approval
October 16th 2023Aldeyra Therapeutics encounters a significant setback, with its stock value plummeting nearly 70%. The FDA indicates a potential Complete Response Letter (CRL) for reproxalap, a dry eye treatment, despite a scheduled Prescription Drug User Fee Act (PDUFA) date of November 23, 2023.
World Sight Day 2023: Avoidable sight loss costs US economy billions
October 12th 2023A groundbreaking study conducted by the International Agency for the Prevention of Blindness (IAPB) and Kevin Frick, PhD, from Johns Hopkins University reveals that prioritizing better eye health could inject a staggering $50.4 billion annually into the US economy.
Ocuphire Pharma and Viatris developed the drug together for the reversal of pharmacologically-induced mydriasis (RM) produced by adrenergic agonist or parasympatholytic agents.
FDA issues CRL for aflibercept 8 mg from Regeneron Pharmaceuticals
The company announced the Complete Letter Response from the FDA for the Biologics License Application for aflibercept 8 mg is “solely due to an ongoing review of inspection findings at a third-party filler."