• Bausch + Lomb and Novaliq GmbH announced the FDA approved MIEBO (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO is the first FDA-approved treatment for DED that directly targets tear evaporation. The FDA approval of MIEBO was based on the results from the GOBI and MOJAVE Phase 3 pivotal studies, that met both primary sign and symptom efficacy endpoints. The company expects to make MIEBO commercially available in the second half of this year. 

• Alimera Sciences announced its acquisition of additional commercialization rights for YUTIQ (fluocinolone acetonide intravitreal insert) 0.18 mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye from EyePoint Pharmaceuticals. Alimera now has exclusive global rights to YUTIQ, excluding China, Hong Kong, Taiwan, Macau, South Korea and Southeast Asia, where EyePoint has a pre-existing license with Ocumension Therapeutics. Under the terms of the agreement with EyePoint, Alimera made an upfront cash payment of $75 million at closing; an additional $7.5 million will be paid in equal quarterly installments in 2024. EyePoint will also receive potential royalties from 2025 to 2028 based on combined net revenues in the United States from ILUVIEN and YUTIQ in excess of certain thresholds, beginning at $70 million in 2025 and increasing annually thereafter. Alimera will immediately assume control of all commercial activities related to YUTIQ in the United States.

• Adverum Biotechnologies presented new nonclinical data on an intravitreal (IVT) gene therapy for the treatment of geographic atrophy (GA) secondary to dry AMD via expression of complement Factor I (CFI) at the American Society of Gene & Cell Therapy 2023 annual meeting. GA Poster highlights noted that CFI naturally blocks the activity of proteins involved in complement overactivation. Continuous expression of CFI in ocular tissue holds the possibility to inhibit complement overactivation, thereby halting GA lesion growth and preserving vision for dry AMD patients. 7m8 and loop swap variant 1 capsids packaged with adeno-associated virus (AAV)-CFIco, yielded robust intraocular human CFI levels in non-human primates. Additionally, IVT administration of AAV-CFIco via both proprietary capsids was well tolerated, with no anti-inflammatory steroids used at any timepoint in the nonclinical study. Adverum concluded that administering an AAV-mediated therapy to express CFI in patients via IVT delivery, a routine in-office procedure, could be an ideal treatment profile for a widely adoptable treatment for GA. For additional poster highlights click here. 

• Prevent Blindness will host the 12th annual Prevent Blindness Focus on Eye Health Summit on July 12-13, 2023, as a virtual interactive event. Expert presentations related to this year’s theme, “Why the Eye?” will engage diverse voices in discussions around vision health as it relates to public health, stimulate conversations around the challenges to equitable access to eye care, explore new and unique collaborations across stakeholders, and identify opportunities to integrate vision and eye health into public health policies, practices, and research advancement. This global event offers simultaneous access to expert presentations, an exhibitor hall, educational materials, videos, and toolkits, and in-platform opportunities for networking and collaboration. Expected attendees include patient advocates, community-based and advocacy organizations, national vision and eye-health organizations, researchers, health-care providers, educators, early childhood education professionals, senior- and child-care professionals, government agency staff, corporate partners, health program professionals, legislative staff, and more. Visit PreventBlindness.org/eyesummit to register and for more details.

• The National Eye Institute published "Stem cell sources and characterization in the development of cell-based products for treating retinal disease: An NEI town hall report." Based on input from subject matter experts, the report provides guidance for research in support of future clinical trials. The report addresses barriers to advancing the field of regenerative medicine for vision as well as opportunities to accelerate research. Topics include quality control, sourcing of stem cells, genetic modification and cellular reprogramming, immune considerations, and the therapeutic potential of extracellular vesicles —cell-secreted sacs that can contain regenerative factors. The report is available free for download from PubMed Central. 

• In a University of California, Irvine-led study, published in the Proceedings of the National Academy of Sciences, researchers discovered small-molecule drugs with potential clinical utility in the treatment of AMD, diabetic retinopathy and retinitis pigmentosa. The study introduced a new class of therapeutics called Stress Resilience-Enhancing Drugs (SREDs) for the treatment of neurodegenerative conditions. Through selective, pharmacological inhibition of cyclic nucleotide phosphodiesterases, the prototypical SREDs slowed or halted the development and progression of retinopathies in a number of genetic and environmental animal models. The SRED therapeutic intervention enhanced resilience to acute and chronic forms of stress in the degenerating retina, thus preserving tissue structure and function across multiple models of age-related or inherited retinal disease. For more, see the study results here.

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