• Azura Ophthalmics presented new positive 6-month data at ASCRS evaluating its lead drug candidate AZR-MD-001 for meibomian gland dysfunction (MGD). In the studies, AZR-MD-001 met the co-primary endpoints at 3 months. In addition, longer-term data showed that treatment with AZR-MD-001 for up to 6 months further improved signs and reduced symptoms of MGD. Azura plans to initiate a pivotal Phase 3 multi-center, double-masked, vehicle-controlled, randomized clinical trial of AZR-MD-001 in MGD in 2024. The company says this will advance its goal towards potentially developing the first ophthalmic keratolytic to treat ocular surface diseases. For details on poster presentations at the upcoming ARVO meeting, click here.

• New research from the University of Pittsburgh published in Nature Communications explains why metastatic uveal melanoma is resistant to conventional immunotherapies and how adoptive therapy, which involves growing a patient’s T cells outside the body before reinfusing them, can successfully treat this rare and aggressive cancer. The researchers also explain how they developed a new clinical tool, Uveal Melanoma Immunogenic Score (UMIS), that predicts which patients will respond to adoptive therapy. UMIS is a holistic measure of the tumor that reflects the activity of more than 2,000 genes expressed by tumor cells, immune cells and other cells that form the tumor microenvironment. UMIS ranged from 0.114 to 0.347 across 100 metastases, with higher values indicating tumors with more potent TILs. When the researchers looked at patients who received adoptive therapy in an earlier study, they found that patients with higher UMIS scores had better tumor regression, suggesting that this biomarker could predict which patients are likely to respond. For more, see the study results here.

• Scientists at the Medical College of Georgia at Augusta University established an Aqueous Humor (AH) Proteome Database that will allow researchers to better examine the underlying causes of some of the most common conditions that cause vision loss. This new database includes data from 307 human AH samples, comprehensive information on 1,683 proteins identified in the AH, as well as relevant clinical data for each analyzed sample. The database is publicly accessible, and, as additional samples are collected and analyzed, the proteomic and corresponding clinical data will be incorporated. The research team also plans to add functions that allow other users to upload their own AH proteomic data to the database. The team’s work was recently published in Database, The Journal of Biological Databases and Curation.

• Ocugen Inc. announced dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA) — a modifier gene therapy candidate being developed for geographic atrophy (GA). Dosing in the second cohort is complete, and three subjects received 200 mL single subretinal administration of the medium dose (5x10¹⁰ vg/mL) of OCU410. The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels [low dose (2.5×10¹⁰ vg/mL), medium dose (5×10¹⁰ vg/mL) and high dose (1.5 ×10¹¹ vg/mL). Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to one of two OCU410 treatment groups or to an untreated control group.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.