Faricimab is currently approved in more than 70 countries to treat nAMD and DME, with more than 1 million doses distributed globally, and Genentech will highlight its ophthalmology portfolio at the American Society of Retina Specialists annual meeting in Seattle.
According to Regeneron, visual gains and safety of aflibercept 8 mg remained consistent with the established profile of aflibercept 2 mg Injection.
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.”
Eyebiotech noted its AMARONE trial will evaluate the safety and preliminary efficacy of intravitreal EYE103.
The trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy.
In a Wilmer Eye Institute study, in mice and human cell models, the drug 32-134D lowered protein levels known to contribute to diabetic macular edema and diabetic retinopathy
According to the company, THR-149 is currently being evaluated in the KALAHARI Phase 2, Part B clinical trial as a potential treatment for patients who respond suboptimally to anti-VEGF, the standard of care for treatment of DME.
According to the company, AG-73305 was found to be safe and tolerable with no severe adverse effects after a single intravitreal injection of 0.5 mg and 1 mg in patients diagnosed with diabetic macular edema.
According to the company, the study has now reached its goal of 300 patients enrolled to evaluate ILUVIEN as a first line, baseline therapy for DME.
According to the company, the Phase 1 trial is a multicenter, open-label, dose-escalation safety clinical trial. Up to 24 subjects will receive a single periocular injection and will undergo monthly evaluation for up to 6 months to assess safety, tolerability, and efficacy measured by best corrected visual acuity.
According to the company, the DIAMOND trial in diabetic macular edema with topical OCS-01 met its stage 1 objective of validating the loading and maintenance dosing regimen designed to optimize OCS-01 efficacy potential with robust statistical significance.
Ophthalmology Times® talked with David Tabano, PhD, from Genentech about the company's first real-world data readouts for faricimab in the treatment of DME at this year's ARVO meeting.
Ophthalmology Times® talked with David Brown, MD, about the PHOTON study examining the safety and efficacy of high-dose aflibercept for the treatment of diabetic macular edema (DME) at this year's ARVO meeting.
Post-hoc analyses from four Phase III studies indicate Vabysmo dried retinal fluid faster with fewer injections in wet age-related macular degeneration and diabetic macular edema.
Ophthalmology Times® talked with Roger Goldberg, MD, MBA, about macular leakage area in the YOSEMITE and RHINE trials comparing faricimab to aflibercept at this year's ARVO meeting.
Many patients with diabetes can be stabilized with anti-VEGF biologics.
According to researchers, diabetes mellitus is caused by higher levels of blood glucose due to the lack of production of insulin by the body, resistance to insulin, or both.
Lessons learned from a pilot will inform future collaborative work between the ADA and Genentech to improve health equity in eye care for people living with diabetes.
If approved, OCS-01 has the potential to become the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.
The regulatory milestone fulfills the company’s goal to file the IND for OCU200 within the first quarter of 2023.
David S. Boyer, MD, presented data from the PHOTON study examining the safety and efficacy of high-dose aflibercept for treatment of diabetic macular edema at the 2023 Angiogenesis, Exudation, and Degeneration conference.
According to Regeneron, the BLA is supported by two pivotal trials demonstrating non-inferior vision gains to aflibercept injection, with a majority of patients maintaining extended dosing regimens through 48 weeks.
During the EnVision Summit Ophthalmology in Puerto Rico, Victor Villegas, MD, made a presentation titled "From a Retina Perspective: Comanagement of AMD, DME and CME in the Setting of Cataract Surgery," focusing on how to comanage patients that have macular degeneration, diabetic maculopathy and cystoid macular edema.
Sharing data between ophthalmologists, optometrists can lead to earlier diagnosis
The Phase 2 SPECTRA clinical trial will assess 4D-150 in patients with DME.
