Diabetic Macular Edema

An end-of-week review of retina news and stories from October 29-November 3, 2022.

The Sailing study was a 12-month, 18-center, randomized, double-masked, double-sham, parallel-controlled, phase 3 trial that was conducted in China and included eyes with center-involved DME that were randomly assigned to undergo either laser photocoagulation followed by as-needed sham intravitreal injections or sham laser photocoagulation followed by as-needed 0.5 mg intravitreal injections of conbercept.

Data highlights need for educational materials and training resources in DME and DR.

The data analysis showed that the macular thickness decreased across all time periods and in all macular regions for all tertiles.

The data analysis indicated that patients achieved robust visual gains and central subfield thickness reductions with faricimab dosed every 8 weeks and with PTI dosing up to every 16 weeks. The gains were sustained through year 2 of the trials.

The drug’s efficacy was reported to be superior to that achieved with laser photocoagulation.

Roche’s treatment of faricimab is the first and only FDA-approved medicine targeting two distinct pathways, angiopoietin (Ang)-2 and vascular endothelial growth factor (VEGF)-A, that often cause retinal diseases that may cause visual loss.

Oral APX3330 was found to demonstrate favorable safety and tolerability profile in interim masked safety results, consistent with 11 prior trials of APX3330.

Regeneron announced that the primary endpoints were met in two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema and wet age-related macular degeneration.

The first stage of the study will evaluate the safety and relative pharmacodynamic effect of different doses of subcutaneously administered D-4517.2 compared to intravitreal injection of aflibercept, an approved therapy, in both wet AMD and DME patients up to 12 weeks.

The investigators retrospectively analyzed treatment-naive eyes with DME which received intravitreal treatment with either ranibizumab 0.5 mg or aflibercept 2 mg. All data were collected in the Fight Retinal Blindness! registry.

This year’s hybrid meeting will allow attendees to participate in person or virtually. Either way, this congress will offer a wealth of information to specialists covering all aspects of retinal diseases.

David A. Eichenbaum, MD, FASRS, reviews the case of a 74-year-old male with diabetic macular edema (DME).

Kodiak Sciences Inc. announced that its BEACON Phase 3 study of tarcocimab, its novel antibody biopolymer conjugate, met the primary endpoint of non-inferior change from baseline in visual acuity at week 24 compared to aflibercept in patients with macular edema due to retinal vein occlusion.

A retina specialist discusses impressions and key takeaway points from the case of a 73-year-old female with treatment experienced nAMD.

Rishi Singh, MD reviews the case of a 73-year-old female with treatment experienced neovascular age-related macular degeneration (nAMD).

A retina specialist discusses impressions and key takeaway points from the case of a 59-year-old male with DME.

Dr Rishi Singh reviews the case of a 59-year-old male with diabetic macular edema (DME).

Treatment reduces burden of care, providing another option for patients diagnosed with diabetic macular edema.

Survey respondents point to a perceived gap in treatments for uveitic macular edema, document interest in suprachoroidal drug delivery.

The U.S. Centers for Medicare and Medicaid Services code is effective July 1 and will enhance access to Xipere, the only therapy available in the United States for suprachoroidal use in the treatment of macular edema associated with uveitis.

A team of investigators has found that a comparison of ranibizumab and aflibercept showed both drugs safe and effective for treating diabetic macular edema.

According to Novartis, the approval is based on year 1 data from the Phase III KESTREL and KITE clinical trials investigating brolucizumab-dbll 6 mg vs aflibercept 2 mg in diabetic macular edema patients.

Jeff Cleland, PhD, CEO of Ashvattha, discusses safety data for an at-home subcutaneous anti-VEGF injection option in development for the treatment of wet AMD and DME.

Professor Anat Loewenstein, MD, discusses data regarding the efficacy of faricimab at targeting both the VEGF and Ang2 pathways in patients with neovascular AMD and diabetic macular edema.

According to the company, the trial did not demonstrate efficacy on the key clinical endpoints. As a result, Oxurion will now shift its focus to the Phase 2 development program for THR-149, which recently demonstrated a compelling safety and efficacy profile for the treatment of DME.

The data presented at ARVO showed single subcutaneous doses of D-4517.2 were safe, well-tolerated in healthy subjects.

The trial will study the effect of the drug in treatment-naïve patients with diabetic macular edema (DME) who are members of underrepresented patient populations, ie, Black, Hispanic, Latin American, and Indigenous people.

Investigators found that patients with neovascular age-related macular degeneration in all countries included in the study lost vision as a result of the lockdown and reduced number of treatments during the COVID-19 pandemic.

Approval is based on year 1 data from the Phase III KESTREL and KITE trials investigating brolucizumab 6 mg versus aflibercept 2 mg in DME patients.