Weekly Ophthalmic Newsletter

Weekly Ophthalmic Newsletter

1. UC Davis Health Tests Experimental Gene Therapy for Wet AMD

Ophthalmologists at UC Davis Health used an experimental gene therapy to address wet age-related macular degeneration (wet AMD) in a patient. This marked the UC Davis Eye Center's first use of gene therapy.

The treatment formed a component of a phase 3 clinical study, employing a randomized, partially masked, controlled approach, to assess the efficacy and safety of ABBV-RGX-314, an experimental therapy, for wet AMD. UC Davis Health is among 93 U.S. sites engaged in this clinical trial.

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2. Researchers Discover a Nanobody to Treat Retinitis Pigmentosa

A group of researchers from the University of California, Irvine, has made a significant discovery: an exceptional antibody that could pave the way for treating Retinitis Pigmentosa. This condition results in the deterioration of central vision, as well as night and color vision.

The researchers at UCI have concentrated their investigation on a specific molecule with the conviction that it holds the potential to offer a remedy for Rhodopsin-associated autosomal dominant RP (adRP). The molecule in question, Rhodopsin, stands as a pivotal photosensitive molecule in the human retina. It is found within rod photoreceptor cells, and mutations within the Rhodopsin gene constitute a principal cause of adRP.

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3. Researchers Invent Tear-Generated Battery for Smart Contact Lenses

Researchers at 新加坡南洋理工大学 have invented an ultra-thin, flexible battery, comparable in thickness to the human cornea. This innovative battery stores energy when submerged in a saline solution, offering the potential to one day power smart contact lenses.

The battery developed by NTU is crafted from biocompatible materials and does not incorporate any wires or harmful heavy metals typically found in lithium-ion batteries or wireless charging systems. It features a glucose-based coating that interacts with sodium and chloride ions present in the surrounding saline solution, with the water within the battery serving as the conduit for electricity generation.

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4. Detailed Eye Atlas Holds the Key to Novel Therapies for Eye Diseases

After over a decade of research, 美国哈佛大学 scientists have concluded a comprehensive analysis that not only holds the potential to guide more effective and precise gene therapies for vision impairments but also fosters a deeper understanding of the intricate complexity of human vision.

Under the leadership of neurobiologist Joshua Sanes, the team has compiled a comprehensive inventory of nearly 160 cell types present in all the structures of the human eye. Additionally, they have documented the genes expressed by each of these cell types. Their findings, referred to as a "cell atlas of the human eye," are presented in detail in the journal Proceedings of the National Academy of Sciences.

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5. FDA Declines to Approve Outlook Therapeutics’ Lytenava for Wet AMD

Outlook Therapeutics, Inc. announced that the FDA has issued a complete response letter (CRL) regarding the company's Biologics License Application (BLA) for ONS-5010 (Lytenava). ONS-5010 is an investigative ophthalmic formulation of bevacizumab aimed at treating wet AMD.

While the FDA recognized the successful fulfillment of safety and efficacy benchmarks in the NORSE TWO pivotal trial, Outlook indicated that, within this evaluation phase, the FDA could not grant approval for the BLA due to 'several CMC issues, open observations from preapproval manufacturing inspections, and a lack of substantial evidence.'

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