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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…
Q&A: Frank Holz shares how innovation showcased at EURETINA brings hope for patients with GA | Ophthalmology Times
Photo of Frank Holz at the 2025 EURETINA meeting Frank Holz, MD, FEBO, FARVO, a retina specialist from Bonn, Germany, discusses the EURETINA meeting, highlighting groundbreaking advancements in retinal disease treatments. With a record attendance of over 11,000, the conference…
Heterogeneous Ocular Biomarkers May Predict Sjögren’s Disease Extraocular Features | Ophthalmology Times
(Image Credit:AdobeStock) A study of the ocular features of Sjogren’s disease reported the heterogeneity of the disorder’s ocular presentations.1 The authors, led by research fellow Drew C. Baeza, MD, and associates, reported “distinct associations between specific dry eye and the…
Chronic nAMD With Cataract Complications: Visual Stabilization Through Sequential Anti-VEGF Strategies | Ophthalmology Times
Treatment-Resistant Retinal Disease Management With Sequential Anti-VEGF Strategies This comprehensive presentation examines complex retinal disease management using sequential anti-VEGF therapies, supported by pharmacokinetic modeling from 17 aflibercept trials involving 2700 individuals. The data demonstrates that aflibercept 8 mg exhibits 34.4%…
DME Management With Transition to High-Dose Aflibercept Following Suboptimal Response to Standard Anti-VEGF Therapy | Ophthalmology Times
DME Management With High-Dose Aflibercept Summary This presentation discusses DME management, focusing on transitioning to high-dose aflibercept following suboptimal responses to standard anti-VEGF therapy. The session was part of a Case-Based Roundtable meeting held in conjunction with the American Society…
Vizz officially launches in the United States | Ophthalmology Times
(Image Credit: AdobeStock) Following a US Food and Drug Administration approval back in July 2025, LENZ Therapeutics has announced that VIZZ (aceclidine ophthalmic solution) 1.44% is now commercially available.1 The first and only FDA-approved aceclidine-based eye drop is for the…
David Lally discusses the ARCHER trial and the optimistic outcomes fueling future research | Ophthalmology Times
Note: Video captions are generated with the assistance of AI and may contain errors. David Lally, MD, presented at the 2025 Retina Society meeting, discussing the ARCHER study (NCT04656561) of ANX007 for the treatment of age-related macular degeneration (AMD) and…