DME

In this insightful discussion on changing therapeutic approaches in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), Judy Kim, MD and Peter Kaiser, MD address barriers like step therapy and the impact of insurance-guided choices on treatment outcomes. The conversation emphasizes the need for a personalized approach, citing clinical trial data while acknowledging the challenges of aligning real-world practices with stringent trial protocols.

Twelve-week data from the Ph1b/2a AMARONE trial reveals Restoret to be well-tolerated in patients with diabetic macular edema and neovascular age-related macular degeneration.

The trial will evaluate tivozanib eye drops (KHK4951), a small-molecule vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3 tyrosine kinase inhibitor (TKI), in patients in with DME.

A minimum of 5,000 patients with up to 5 years of follow-up will be included in the study, with patients from a variety of practice settings and clinician experiences in 28 countries and 500 sites

Kamuvudines are a new class of inflammasome inhibitor drugs as therapies for prevalent, degenerative diseases. The trial is evaluating SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor.

The GLYCO Phase 2 US clinical trial will evaluate AVD-104 for the management of diabetic macular edema (DME).

According to the company, EYP-1901 is an investigational sustained delivery therapy containing vorolanib, a selective tyrosine kinase inhibitor formulated in bioerodible Durasert E.

According to the company, if approved, OCS-01 has the potential to become the first topical eye drop and non-invasive treatment option for DME.

Rishi Singh, MD, provides an overview of biosimilars in the context of retinal diseases and discusses their significance within the healthcare system.

The Kingfisher Study found that the visual outcomes after 1 year of brolucizumab, 6 mg, (Beovu, Novartis) in participants with diabetic macular edema (DME) did not differ significantly from those obtained with aflibercept

Oxurion’s novel PKal Inhibitor, THR-149, did not meet its primary endpoint in the clinical trial.

Previously, the EMA had approved Eylea in a dosage of 2 mg. After considering the EMA’s recommendation, the European Commission will decide whether to issue final approval of the drug.

The Phase 3 DIAMOND trial of OCS-01 in Diabetic Macular Edema (DME) presents encouraging results, meeting primary and secondary endpoints.

Resolution of macular leakage is an early biomarker of vascular stability.

In this key role, Weil will lead the organization to commercial readiness from designing launch strategies for the US and globally.

According to the company, 4D-150 comprises its customized and evolved intravitreal vector, R100, and a transgene cassette that expresses both aflibercept and a VEGF-C inhibitory RNAi.

According to Regeneron, the approval was based on data in the PULSAR and PHOTON trials, in which the drug demonstrated clinically equivalent vision gains to aflibercept Injection 2 mg that were maintained with fewer injections.

The trial is a prospective, multi-center, open label, single-armed trial which plans on enrolling 24 eligible subjects with cystoid macular edema.

In the study, researchers found that nearly one-quarter of anti-VEGF injections were received at least 1 week later than intended.

At the 2023 ASRS meeting in Seattle, Washington, Diana Do, MD joined our team to discuss the 2-year data on the PHOTON study, which involved 8 milligrams of aflibercept for diabetic macular edema.

The company also provided an update on tarcocimab development program for the treatment of neovascular age-related macular degeneration and diabetic macular edema.

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.