- tags:DME
Pipeline
Genentech reports phase 4 Vabysmo data among underrepresented DME patients
Study is referred to as the first retinal trial to focus on this patient demographic, finding similar average vision gains to prior research.
Pipeline
Eclipse Life Sciences launches phase 2 trial on DME steroid implant
Intravitreally-injected implant is being evaluated as a 6-month, extended release therapeutic option.
Research
Vabysmo provides long-term durability in DME extension study
Four-year data finds nearly 80% of patients extended treatment intervals to 3 or 4 months, with 90% reporting absence of DME.
Products
SUSVIMO phase 3 data supports sustained efficacy for DR, DME
FDA has also accepted Genentech’s sBLA for the sustained-release drug delivery system’s diabetic eye disease indications.
Business
Merck officially enters ophthalmic space with EyeBio acquisition
Pharmaceutical giant now owns Restoret (EYE103), an investigational, tri-specific antibody for DME and wet AMD.
Products
Genentech's Vabysmo PFS earns FDA approval for retinal diseases
Prefilled Syringe version of the bispecific antibody is indicated for treating wet AMD, DME, and RVO.
Products
FDA approves EYLEA biosimilar for serious retinal diseases
Formycon reports the generic biosimilar demonstrates a comparable efficacy, safety, pharmacokinetics, and immunogenicity to Regeneron’s aflibercept.
Research
How prevalent are hyper-reflective foci in DME?
Researchers find potential link between HRF and disease severity among diabetic macular edema patients.
Business
ANI Pharmaceuticals to purchase Alimera Sciences
Acquisition expands ANI’s ophthalmic foothold with the addition of two FDA-approved therapeutics: ILUVIEN and YUTIQ.Business
Merck to acquire Eyebiotech in deal worth up to $3B
Agreement involves EyeBio’s lead retinal vascular disease candidate, Restoret, designed as an intravitreal injection for DME and wet AMD patients.
Products
FDA approves first interchangeable aflibercept biosimilars
Generic equivalents to Eylea demonstrate a comparable quality, safety, and efficacy profile for wet AMD, DME, RVO, and DR.
Research
Study examines DME, PDR risk with popular diabetes drugs
GLP-1 agonists linked with a higher rate of progression to PDR and risk of new-onset DME.
Pipeline
FDA accepts Eluminex's IND for DME trispecific fusion antibody
Protein therapeutic is formulated for intravitreal injection and targets key angiogenesis pathways: VEGF-A, VEGF-B, placental growth factor, Ang-2, and IL-6R.
Research
Regeneron reports extended dosing data on EYLEA HD for wet AMD and DME
Published in The Lancet, extended dosing intervals at 12 and 16 weeks shows potential for fewer injections
Business
Sandoz completes acquisition of Coherus's ranibizumab biosimilar
Company looks to continue expanding its ophthalmology portfolio.
Research
New therapeutic may benefit DME in the long term
Phase 1 study data suggests intravitreal injection of novel senolytic therapy is safe and effective in treating DME.
Pipeline
EyeBio presents positive data on Restoret from AMARONE trial for DME and wet AMD
First-in-human study reports Wnt pathway agonist candidate to be well-tolerated, finding proof of concept established with visual and anatomical outcomes.
Research
Researchers identify critical drawbacks for uninsured DR patients
Retrospective study explores link between uninsured patients and risk of DR progression.
Pipeline
First patient dosed in Oculis' phase 3 trial of OCS-01 for DME
Stage 2 of the DIAMOND study follows positive results from the first stage, reported in May 2023.
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