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EMA CHMP issues positive opinion for aflibercept biosimilar from Celltrion

AMD-HALT program receives Eurostars grant for continued investigation of dry AMD gene therapy platform
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EXG102 and EXG202 are investigational gene therapy candidates for wet age-related macular degeneration that are in development.

EXG102 and EXG202 are investigational gene therapy candidates for wet age-related macular degeneration that are in development.

ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8.

The company begins phase 1 trials of oral GAL-101, targeting amyloid beta aggregation. Promising safety and efficacy in ophthalmic models suggest potential for treating dry AMD, glaucoma, and neurodegenerative eye diseases.

SOL-1 is a superiority study being conducted under a Special Protocol Agreement (SPA) with the US Food and Drug Administration (FDA).

EyePoint Pharmaceuticals has dosed the first patient in the LUCIA Phase 3 trial of Duravyu for wet AMD. The study evaluates Duravyu’s efficacy, durability, and re-dosing every 6 months in both treatment-naïve and previously treated patients. Topline data is anticipated in 2026.

The trial is expected to close randomization in early December 2024.

Sozinibercept will be featured as part of an oral presentation at the annual FLORetina Congress being held on December 5-8, 2024 in Florence, Italy.

In a study, a team of Korean researchers developed an AI model using OCT images to predict neovascular AMD treatment outcomes after anti-VEGF injections. The model highlights AI’s potential in personalized ophthalmic care.

A study suggests that small hyperreflective retinal foci (HRF) on OCT images, linked to activated microglial cells, could serve as a valuable marker for monitoring neuroretinal inflammation and progression in age-related macular degeneration.

Arshad Khanani, MD, MA, FASRS, presented positive data from the phase 2 fellow eye sub-study evaluating the subretinal delivery of ABBV-RGX-314.

ABI-110 has the potential to offer a durable and effective solution by addressing the root causes of wet AMD at the genetic level.

Connell’s appointment was effective immediately after the Annual General Meeting of the Company on November 15, 2024.

ABI-110 has the potential to offer a durable and effective solution by addressing the root causes of wet AMD at the genetic level.

The CHMP has recommended FYB203 for approval in Europe for treating adult patients with age-related neovascular macular degeneration (nAMD) and other serious retinal diseases.

Gupta is a nationally recognized retinal surgeon and an entrepreneur whose knowledge and experience on the phases of drug development and medical devices.

After closing, the combined company is expected to operate under the name Kalaris Therapeutics, Inc.

Both LUNA and OPTIC were designed to assess a broad wet AMD population, including hard-to-treat patients with severe disease who required frequent anti-VEGF injections before enrolling in the trial.

LUNA is an ongoing double-masked, randomized Phase 2 trial. OPTIC is an ongoing, open-label, dose-ranging first-in-human trial.

Gregg T. Kokame, MD, MMM, FASRS, is set to share data from a predefined subgroup of the sozinibercept Phase 2b wet AMD trial related to patients with polypoidal choroidal vasculopathy (PCV), measured at 24 weeks.

News
The California Institute for Regenerative Medicine has funded Keck School of Medicine of USC translational research advancing a therapy for dry age-related macular degeneration, one of the leading causes of blindness in older adults.


Afqlir (aflibercept) is a 2 mg vial kit and pre-filled syringe for intravitreal injection.

Neovascular macular degeneration is multifactorial, which requires future agents to target multiple pathways.

"The De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of photobiomodulation (PBM) devices..."



























