IVERIC BIO, INC.

Clearside's CLS-AX Phase 2b Trial Data Shows Promise in Treatment-Naïve AMD Patients

3 months ago

• New subgroup analyses from Clearside Biomedical's ODYSSEY Phase 2b trial provide strategic insights for upcoming Phase 3 program in neovascular age-related macular degeneration. • Data presented at the Angiogenesis 2025 meeting supports focusing on treatment-naïve patients and implementing specific visual acuity criteria for future trials. • The 36-week ODYSSEY trial employed a robust design, being randomized, double-masked, and active-controlled across multiple centers.

Tenpoint Therapeutics' BRIMOCHOL™ PF Shows Positive Phase 3 Results for Presbyopia

4 months ago

• Tenpoint Therapeutics' BRIMOCHOL™ PF met primary endpoints in the BRIO-II Phase 3 trial, demonstrating statistically significant near vision improvement over 8 hours. • The study showed BRIMOCHOL™ PF was well-tolerated with no serious adverse events during the 12-month at-home dosing period. • BRIMOCHOL™ PF also demonstrated statistically significant improvement in ocular hyperemia compared to carbachol alone and reduced pupil size. • Tenpoint plans to file a new drug application with the FDA in the first half of 2025, potentially launching in 2026.

Mural Oncology Gears Up for Key Data Readouts of Nemvaleukin in Ovarian Cancer and Melanoma in 2025

5 months ago

• Mural Oncology's ARTISTRY-7 trial evaluating nemvaleukin with pembrolizumab in platinum-resistant ovarian cancer has reached 75% of overall survival events. • Top-line data from ARTISTRY-6, a phase 2 trial of nemvaleukin monotherapy in mucosal melanoma, is expected in Q2 2025, potentially supporting accelerated approval. • Preliminary data for less-frequent intravenous dosing of nemvaleukin in cutaneous melanoma is anticipated in 1H and 2H 2025 for monotherapy and combination therapy, respectively. • Mural Oncology plans to submit an IND application for MURA-8518, a novel IL-18 candidate, in Q4 2025, expanding its cytokine-based immunotherapy pipeline.