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Dompé’s NAION program selected for FDA Commissioner’s National Priority Voucher Program | Ophthalmology Times
(Image Credit: AdobeStock) Dompé was selected by the US Food and Drug Administration (FDA) to participate in the Commissioner’s National Priority Voucher (CNPV) program. Because of this selection, Dompé has received a voucher granting a significantly shortened review timeline for marketing…
Rethinking punctal occlusion as an option for allergic conjunctivitis | Ophthalmology Times
(Image Credit: AdobeStock) The intracanalicular dexamethasone ophthalmic insert (Dextenza; Ocular Therapeutix) incorporates 0.4 mg of dexamethasone into the hydrogel matrix to treat postoperative inflammation and pain following ocular surgery. It is also approved for the treatment of ocular itching associated…
AAO 2025: Diana Do, MD, reviews the real-world use of aflibercept 8 mg | Ophthalmology Times
Note: Video captions are generated with the assistance of AI and may contain errors. Diana Do, MD, a professor of ophthalmology and vice chair of Clinical Affairs at Stanford University’s Byers Eye Institute, presented research on aflibercept 8 mg in…
AAO 2025: Kenneth C. Fan, MD, sees vision gains with MCO-010 in Stargardt disease | Ophthalmology Times
Kenneth C. Fan, MD, MBA, of Retina Consultants of Texas, highlighted findings from the STARLIGHT study at the American Academy of Ophthalmology 2025 annual meeting, held October 18-10, in Orlando, Florida. He focused on the use of MCO-010 optogenetic therapy…
Aurion Biotech releases positive 12-month results from phase 1/2 CLARA trial | Ophthalmology Times
(Image Credit: AdobeStock/tonstock) Aurion Biotech has released positive 12-month results from its phase 1/2 CLARA trial evaluating the safety, efficacy, and tolerability of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. In the CLARA trial, a double-masked,…
AAO 2025: Glaucoma laser surgery with Joel S. Schuman, MD, FACS | Ophthalmology Times
Joel S. Schuman, MD, FACS, of Wills Eye Hospital, presented an update on laser therapies for glaucoma, emphasizing recent innovations in selective laser trabeculoplasty (SLT) and laser cyclophotocoagulation at the American Academy of Ophthalmology 2025 annual meeting, October 18 to…
FDA grants breakthrough therapy designation to Nacuity’s NPI-001 for retinitis pigmentosa | Ophthalmology Times
(Image Credit: AdobeStock) The US Food and Drug Administration (FDA) has granted Nacuity Pharmaceuticals’ N-acetylcysteine amide tablets (NPI-001) breakthrough therapy designation. NPI-001 is Nacuity’s investigational therapy for the treatment of patients with retinitis pigmentosa (RP). It is a GMP-grade formulation…
AAVantgarde’s AAVB-039 gene therapy to treat Stargardt disease receives orphan drug status from FDA | Ophthalmology Times
(Image Credit: AdobeStock/artacet) The US Food and Drug Administration (FDA) has granted AAvantgarde’s AAVB-039 Orphan Drug Designation (ODD) and has also received Clinical Trial Authorisation (CTA) approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). AAVB-039 is an…
Q&A: The ARCHER trial and the importance of continued GA research | Ophthalmology Times
(Image credit: AdobeStock/J Bettencourt) In conversation with Sydney M. Crago, Managing Editor of Ophthalmology Times, David R. Lally, MD, spoke about his presentation at the 2025 Retina Society meeting, which highlighted the results from the ARCHER trial (NCT04656561) of ANX007…
Charles Miller, MD, PhD, on DME research and the initiation of the phase 2b/3 BRUNELLO trial | Ophthalmology Times
Image credit: AdobeStock/MrAshi On September 4, 2025, Merck and EyeBio announced that the companies have initiated the Phase 2b/3 BRUNELLO trial (NCT06571045) to evaluate the candidate MK-3000, formerly known as EYE103 for the treatment of patients with diabetic macular edema…