Minnetonka

Researchers are studying KB801, a specially designed herpes simplex virus type 1 (HSV-1)-based vector that delivers functional human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK). This Phase 1/2, multicenter, double-masked, placebo-controlled trial aims to assess the safety, tolerability, and preliminary effectiveness of KB801 compared to a placebo in healing the persistent corneal epithelial defect (PCED) caused by NK. Participants will be randomly assigned to receive either KB801 or a placebo eye drop once daily for 8 weeks. After the treatment period, they will return for a follow-up visit 2 weeks later to check on safety and corneal healing. Additional safety follow-up visits will take place every 3 months for approximately one year to monitor the durability of the treatment effects and ongoing safety. During the study, participants will undergo evaluations to monitor adverse events and the healing of the corneal defect. The main outcomes measured are the safety and tolerability of KB801 based on the frequency and severity of side effects, as well as the rate of complete healing of the corneal defect after 8 weeks of treatment. Long-term safety will be assessed through regular follow-up visits over about one year, ensuring comprehensive monitoring throughout the study.

Researchers are evaluating the safety and effectiveness of CSB-001 Ophthalmic Solution 0.1%, a biological treatment containing human recombinant dHGF, in adults aged 18 to 80 years with recent corneal scars. These scars must have formed from a corneal injury diagnosed within the past 7 to 30 days and affect vision. The study is a Phase 1, open-label trial focusing on participants with scars centrally or paracentrally located on the cornea. All participants will receive the CSB-001 treatment starting on Day 1, dosing either three or four times daily until Day 14. If a participant’s scar resolves by Day 7, they will stop treatment and return for follow-up on Day 14. Further clinic visits for safety and effectiveness checks are scheduled on Days 21, 28, 56, and at Month 3. During the study, participants will undergo various safety assessments including adverse event monitoring, eye examinations using slit-lamp biomicroscopy, and vision tests measuring best-corrected distance visual acuity from screening through Day 56. The total study duration allows for careful observation of treatment effects and safety over a three-month period.

Researchers are evaluating the safety and effectiveness of CSB-001 Ophthalmic Solution 0.1%, a human recombinant dHGF drug, in adults with limbal stem cell deficiency (LSCD). The study focuses on participants who have a qualifying diagnosis of LSCD with specific signs in the central cornea and stable dosing history if using Acthar. This is an open-label Phase 1 study designed to assess how this investigational eye treatment performs in affected individuals. Participants will receive CSB-001 in one or both eyes during two identical dosing phases separated by a 31- to 40-day break called the Dosing Holiday, during which no drug is given. After these dosing phases, there is a noninterventional Observation Phase where no treatment is administered but participants are monitored. This design allows researchers to study the impact of the drug and observe the eyes over time. During the study, safety is closely monitored through adverse event reports and eye examinations including slit-lamp biomicroscopy and vision tests measuring best-corrected distance visual acuity. These assessments occur from the start of dosing through 144 weeks. Participants undergo regular clinical evaluations to track treatment effects and eye health, ensuring detailed safety and efficacy data collection over nearly three years of follow-up.