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Santen, Arctic Vision to Launch ARVN001 in China
Clearside Biomedical has announced that Arctic Vision, its Asia-Pacific partner, has signed a commercial collaboration agreement with Santen Pharmaceutical Co. for ARVN001 (known in the United States as XIPERE) to treat uveitic macular edema (UME) and additional ophthalmic indications in…
FDA Approves LumiThera’s Valeda for Dry AMD Treatment
The U.S. FDA has granted LumiThera authorization to market its Valeda Light Delivery System, the first FDA-authorized device designed to treat vision loss in patients with dry age-related macular degeneration (AMD). This significant approval, obtained through the De Novo authorization…
Genentech: Vabysmo Effective for Diverse DME Patients
Genentech recently announced encouraging one-year results from its phase 4 ELEVATUM study evaluating Vabysmo (faricimab-svoa) for diabetic macular edema (DME) in racially and ethnically underrepresented populations. The findings, presented at the American Academy of Ophthalmology (AAO) 2024 annual meeting in…
FDA Clears HG202 CRISPR Therapy for Wet AMD Trials
The U.S. FDA has granted investigational drug clearance for HG202, a pioneering CRISPR/Cas13Y RNA-editing therapy developed by HuidaGene to treat neovascular (wet) age-related macular degeneration (AMD). This milestone makes HG202 the first CRISPR/Cas13Y RNA-targeting therapy in clinical development and the…
BlueRock Therapeutics’ OpCT-001 Receives FDA Clearance
BlueRock Therapeutics, a subsidiary of Bayer, announced that the FDA has cleared its investigational new drug (IND) application for OpCT-001, a stem cell therapy designed to treat primary photoreceptor diseases. The clearance allows BlueRock to initiate a phase 1/2a clinical…
Atsena Publishes 12-Month Data on ATSN-101 for LCA1
Atsena Therapeutics announced that 12-month safety and efficacy data from its Phase I/II trial of ATSN-101, a gene therapy for Leber congenital amaurosis caused by GUCY2D mutations (LCA1), were published in The Lancet. ATSN-101 showed durable improvements in vision at…
Aviceda’ Kicks off Phase II/III SIGLEC Trial for AMD
Aviceda Therapeutics has initiated the second part of its Phase II/III SIGLEC trial for AVD-104, an ophthalmic candidate aimed at treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company has dosed the first subject in this phase,…
Foundation Fighting Blindness Launches Gyrate Atrophy Study
The Foundation Fighting Blindness has launched a natural history study targeting gyrate atrophy, a rare and sight-threatening inherited retinal disease. Spearheading this initiative are esteemed researchers Dr. Mandeep S. Singh, MD, PhD, and Dr. David Valle, MD, from the Wilmer…
FDA Clears Eyenuk’s Additional Camera for DR Detection
Eyenuk has received FDA clearance to utilize the Topcon NW400 retinal camera with its EyeArt AI system for automated detection of diabetic retinopathy (DR). This clearance complements the system’s existing clearance for usage with Canon CR-2 AF and Canon CR-2…
Oxular’s OXU-001 Receives IND Acceptence
The U.S. Food and Drug Administration has approved Oxular Limited’s investigational new drug application (IND) for suprachoroidal OXU-001 for the treatment of diabetic macular edema (DME). The IND permits the OXEYE Phase 2 trial to proceed, which will assess the…