Clearside Biomedical (NSDQ:CLSD) said today that its lead drug, in combination with Regeneron‘s (NSDQ:REGN) Eylea, failed in a phase III retinal vein occlusion trial. The trial’s primary endpoint was the proportion of patients in the combination treatment arm, compared to the group receiving just intravitreal Eylea, that experienced improvements in best corrected visual acuity after eight weeks. […]
Clinical Trials
Janssen touts topline data for long-acting, injectable HIV therapy
Johnson & Johnson‘s (NYSE:JNJ) Janssen touted topline results this week from a Phase III trial of its long-acting, injectable two-drug regimen for the treatment of HIV. The study found that long-acting, once-monthly rilpivirine and cabotegravir had comparable efficacy to GlaxoSmithKline‘s (NYSE:GSK) oral Triumeq product. Janssen and ViiV Healthcare also reported that virologic response and drug resistance […]
Mustang Bio studies intraventricular delivery of immunotherapy in Ph1 trial
Mustang Bio (NSDQ:MBIO) said today that it launched a Phase I trial to evaluate the safety and efficacy of intraventricular delivery of CAR T-cells to the brains of people with HER2-positive breast cancer. The 21-patient trial’s primary goal is to determine the recommended dosing regimen for a Phase II trial. Secondary objectives include evaluating the […]
Clearside Biomedical reports analyses from pivotal trial of eye drug
Clearside Biomedical (NSDQ:CLSD) touted new analyses of data from the company’s Phase III pivotal trial of suprachoroidal CLS-TA in people with uveitic macular edema. The company’s investigational treatment is a suspension of triamcinolone acetonide formulated to be delivered to the back of the eye via the suprachoroidal space. Clearside reported that 40% of people taking its […]
Genentech touts data for refillable eye implant in wet-AMD trial
Roche‘s (OTC:RHHBY) Genentech touted additional positive data last week from a Phase II study of its Port Delivery System, a refillable eye implant designed to deliver ranibizumab to treat wet age-related macular degeneration. The company first reported top-line results from the Phase II Ladder study in July. The implant is intended to allow wet-AMD patients to go […]
GenSight Biologics launches trial for gene therapy, eye device combo
GenSight Biologics (EPA:SIGHT) said today that the first person was treated in a first-in-man trial evaluating GenSight’s gene therapy candidate, GS030-DP, in combination with a wearable optronic visual stimulation device, GS030-MD. Scientists are evaluating the drug-device combination in 18 people with retinitis pigmentosa. The Pioneer Phase I/II trial is an open-label, dose-escalation study designed to assess […]
Inovio touts intradermal delivery of HIV vaccine
Inovio Pharmaceuticals (NSDQ:INO) reported today that its synthetic HIV vaccine, Pennvax-GP, demonstrated durable antibody and T cell immune responses throughout a Phase I trial. The company found that Pennvax-GP plasmids delivered intradermally with Inovio’s Cellectra device triggered equivalent or superior immune responses in healthy volunteers compared to intramuscular delivery of the plasmids using the same device. […]
Oyster Point Pharma touts trial results for intranasal dry eye disease drugs
Oyster Point Pharma touted data today from two Phase IIb trials assessing its nasal spray products for the treatment of dry eye disease. Both studies showed that use of OC-01 and OC-02 led to improvements in multiple measures of eye dryness symptoms, according to the Princeton, N.J.-based company. Oyster Point’s Onset study evaluated the safety […]
Flexion reports data from Phase II bilateral osteoarthritis trial
Flexion Therapeutics (NSDQ:FLXN) touted data today from a Phase II trial assessing the bilateral dosing of its extended-release triamcinolone acetonide injection in people with bilateral osteoarthritis. The study found that bilateral injections of Flexion’s Zilretta therapy resulted in lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs). The company also […]
Takeda presents Phase III data for subcutaneous ulcerative colitis drug
Takeda Pharmaceutical (TYO:4502) touted results from a Phase III trial assessing the efficacy and safety of an investigational subcutaneous formulation of vedolizumab, a gut-selective biologic designed for adults with moderately to severely active ulcerative colitis. The 383-patient Visible 1 pivotal Phase III trial included an intravenous vedolizumab reference arm. Patients who achieved clinical response after six […]