Weekly Ophthalmic Newsletter

Weekly Ophthalmic Newsletter

1. FDA Approves Regeneron’s EYLEA? as the First Pharmacologic Treatment for Preterm Infants with ROP

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  • Regeneron Pharmaceuticals announced that the FDA granted its approval for the use of EYLEA? (aflibercept) Injection as a treatment option for preterm infants suffering from retinopathy of prematurity (ROP).
  • This marks the first time that EYLEA has received approval for pediatric use and expands its indications to five different retinal conditions caused by ocular angiogenesis.

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2. Endogena Therapeutics Receives FDA Fast Track Designation for Treatment of Retinitis Pigmentosa

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  • Endogena Therapeutics announced that the US FDA has designated the investigation of its drug EA-2353 for the treatment of retinitis pigmentosa (RP) as a Fast Track development program. This process speeds up the availability of new drugs for serious conditions to patients.
  • EA-2353 is a novel, small-molecule that selectively activates retinal stem and progenitor cells, potentially preserving or restoring visual function. Its gene-independent approach has advantages in treating RP, which has multiple genetic causes. EA-2353 received orphan drug designation from the US FDA in May 2021.

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3. Aldeyra Therapeutics Announces FDA Acceptance of NDA for Reproxalap for Treatment of DED

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  • Aldeyra Therapeutics announced that its New Drug Application (NDA) for topical ocular reproxalap, a first-of-its-kind drug candidate for treating dry eye disease symptoms and signs, has been accepted by the FDA.
  • Reproxalap, a drug candidate currently under investigation, is a first-of-its-kind small molecule that modulates RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory diseases.

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4. Researchers Discover New Genomic Risk Factor for AMD

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  • Researchers at Tel Aviv University have made a groundbreaking discovery in their understanding of the complex eye disease age-related macular degeneration (AMD), a leading cause of vision loss in advanced age.
  • They have identified a new genetic risk factor by discovering proteins that are crucial for the development and operation of the tissue affected by the disease. For the first time, the researchers have determined the precise locations of these proteins in the genome and have established a connection between variations in these genomic regions and the risk for AMD.

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