AMD

Investigational pipeline provides promise for an unmet need.

The first FDA-approved bispecific antibody for the eye targets two leading causes of vision loss.

Reducing the treatment burden is a prime goal for emerging AMD therapies.

Presenters at the conference provided new evidence about detecting geography atrophy and wet and dry AMD early and predicting disease progression. Investigators are also focused on finding cures for inherited retinal diseases.

KSI-301, a therapy for patients with nAMD, did not meet the primary endpoint of showing non-inferior visual acuity gains compared to aflibercept given every eight weeks; however, it was safe and well-tolerated with no new or unexpected safety signals.

Kriya Therapeutics company recently took the wraps off an exclusive agreement with the Medical University of South Carolina (MUSC) Foundation for Research Development to license next generation complement-targeted gene therapies for the treatment of geographic atrophy and other ocular diseases.

According to the company, it is developing elamipretide for treatment of extra-foveal geographic atrophy under U.S. FDA Fast Track designation.

At Angiogenesis, Dr. David Brown presented the Phase 2 results of the CANDELA study for high dose aflibercept 8 milligram for wet AMD; here, he discusses those results.

Robert Bhisitkul, MD, PhD, provided 24-week clinical data from the Phase 1 study, demonstrating that patients with DME and wet AMD showed improved visual acuity through 24 weeks following a single dose of UBX1325.

A brief overview of findings presented at the 2022 Angiogenesis, Exudation and Degeneration meeting hosted by Bascom Palmer.

Most patients (95%) with the PDS implanted did not need supplemental treatment before the refills, indicating the persistence and durability of the treatment.

Previously treated patients showed significantly reduced treatment burden.

At Angiogenesis, Dr. SriniVas R. Sadda discusses how choriocapillaris may predict the rate of progression of atrophy.

In a presentation at the Bascom Palmer Eye Institute’s 19th annual Angiogenesis, Exudation, and Degeneration 2022 Virtual Edition, Glenn J. Jaffe, MD, noted that the analysis showed, for the first time, a decreased growth rate in the central foveal area by a therapeutic intervention when compared to sham treatment.

Dr. Nadia K. Waheed reviews the latest updates on the FOCUS trial, evaluating AAV-based viral vector GT005 for the treatment of geographic atrophy.

This study showed that an investigational subretinal implant, CPCB-RPE1, containing allogeneic human embryonic stem cell-derived RPE cells, was safe and well-tolerated by patients with dry AMD.

Dr. David S. Boyer describes how blocking Connexin-43 may improve the retinal vascular system function in patients with diabetes, potentially creating a future of oral medication for treatment of diabetic retinopathy and AMD.

NGM621 is a monoclonal antibody product candidate engineered to potently inhibit complement C3 for the treatment of patients with geographic atrophy secondary to age-related macular degeneration.

According to the companies, a social media initiative will include donation to Prevent Blindness’ Sight-Saving Fund.

A University of California Davis study shows that small serving of the fruit increased protective pigments in the eye.

Joshua Mali, MD, talks about how the FDA approval of faricimab will change the treatment landscape for wet AMD and DME.

Genentech’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.

A team of investigators are working on a simple test that may someday identify those who can stop therapy.

Across four studies, about half of eligible faricimab patients were able to go 4 months between treatments, and approximately three-quarters could be treated every 3 months or longer. Two papers published in The Lancet highlight one-year results.

Firas Rahhal, MD, discusses Outlook Therapeutics’ Phase 3 pivotal NORSE TWO trial for ONS-5010.

ASCENT, REGENXBIO’s Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada, with pivotal trials expected to support BLA submission for RGX-314 in 2024.

Real-world evidence is growing in importance as a source of information that can help support clinical decision-making when evaluated properly.

Current options, challenges in developing novel therapies.

First annual Geographic Atrophy Awareness Week, hosted by Prevent Blindness, will be December 6-12, 2021.

Patients can get real-time disease monitoring with self-operated device.