AMD

We asked, "What research at ASRS 2023 do you find exciting or interesting?" Here's what Paul Hahn, MD, PhD, Kerrie Brady, BPharm, MBA, MS, and Michael Singer, MD had to say!

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.

According to the company, the MAA submission is based on data from the GATHER1 and GATHER2 Phase III clinical trials.

The study met its primary efficacy endpoint for the neovascular age-related macular degeneration (nAMD) treatment.

According to Regeneron, visual gains and safety of aflibercept 8 mg remained consistent with the established profile of aflibercept 2 mg injection.

The investigators explored the effects of the following covariates on development of AMD: sex, ethnicity, smoking history, fluoxetine use, obesity, diabetes mellitus, and hypertension.

According to the company, the therapeutic is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.

Nancy Lurker, spoke with our team about the subgroup analyses of the Phase 1 DAVIO Trial of EYP-1901 at the 2023 ASRS annual meeting.

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

6-Month results underscore treatment safety with suprachoroidally injected ABBV-RGX-314 for nAMD

According to the company, a pair of presentations at the American Society of Retina Specialists annual meeting in Seattle highlight CLS-AX as a promising wet AMD treatment with a new mechanism of action and the potential for longer duration of effect than current therapies.

The company noted at the American Society of Retina Specialists meeting in Seattle the phase 2 Dose Expansion (N=50) initial interim efficacy and safety data presentation expected at medical conference in H1 2024.

Our team caught up with Baruch Kupperman, MD, PHD who is presenting, "Improving vision and dry AMD matching mechanism with the right patient population and stage of disease" to learn more about this topic.

The intraocular injection of AXT107 microparticulate suspension will be explored in the DISCOVER study.

HLX04-O has the potential to be one of the first bevacizumab approved for use in ophthalmic diseases, benefiting more patients with eye diseases worldwide.

According to the company, Megan Baldwin, PhD, CEO of Opthea Ltd, will provide an overview of the company’s Phase 3 clinical program advancing OPT-302 for the treatment of wet AMD.

Francesca Marassi, PhD, and her collaborators have received a $13 million National Institutes of Health grant to study misplaced calcified deposits that are a misunderstood factor in common diseases of aging, including age-related macular degeneration.

According to the company, initial interim Phase 2 efficacy data is expected to be presented in H1 2024. It also is expected to provide an update regarding Phase 3 pivotal trial plans in Q1 2024 after discussion with the FDA later this year.

Researchers investigated the relationship between visual functioning measured using the National Eye Institute 25-Item Visual Function Questionnaire (VFQ-25) and mortality in patients with various stages of AMD.

While these injections are the standard treatment for this patient population, the investigators found a subgroup of patients who had severe visual loss between 2 consecutive intravitreal injections.

The Icahn School of Medicine at Mount Sinai opened the Center for Ophthalmic Artificial Intelligence and Human Health, which is dedicated to advancing artificial intelligence to offer faster diagnosis and treatment.

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.”

A recently completed non-human primate study of VGX-0111 demonstrated good tolerability, provided strong transgene expression in the targeted region of the retina, and increased production of the lipids whose decline is associated with macular degeneration.

Eyebiotech noted its AMARONE trial will evaluate the safety and preliminary efficacy of intravitreal EYE103.

RAFARM and BioNanoSim have entered into an agreement to create the company.