Palisades Park

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 investigating the safety and effectiveness of NEXAGON® (lufepirsen ophthalmic gel) for people with persistent corneal epithelial defects (PCED) that do not heal with standard treatments. This randomized, multicenter, double-masked, vehicle-controlled Phase 2 study aims to see if NEXAGON can help heal these persistent eye wounds and maintain healing over time. Participants will be randomly assigned to receive either a high dose or low dose of lufepirsen gel or a matching vehicle gel without the active drug. The study includes a Screening Period, followed by a Treatment Period lasting up to 8 weeks, and a 4-week Follow-up Period. If a participant's corneal defect does not heal or if the healing is not durable for 28 days after treatment, they may enter an additional 8-week Open-label Treatment Period with NEXAGON. During the study, participants will be monitored for corneal healing and safety. Researchers will assess whether the corneal epithelium has re-formed and maintained healing for 28 days. Evaluations will include clinical exams and monitoring for any side effects. The total study participation may last up to several months depending on healing and treatment response.

Neurotrophic keratopathy (NK) is a degenerative eye disease caused by nerve damage that reduces corneal sensitivity and harms the health of corneal cells. This trial aims to compare the safety and effectiveness of a new eye drop called RGN-259 against a placebo in treating NK. This Phase 3 study focuses on patients with persistent corneal defects and reduced corneal sensation. Participants will receive either RGN-259, a preservative-free eye drop containing Tß4, or a placebo eye drop without Tß4. Both treatments are applied directly to the affected eye(s) five times daily for 28 days. The study monitors healing progress during this treatment period. Throughout the study, participants will undergo evaluations including eye exams to assess corneal healing, sensitivity testing, and vision measurement. The main result measured is the percentage of patients whose persistent corneal defects fully heal by Day 29. Safety and tolerance of the eye drops will also be closely observed during the treatment and follow-up visits.

This first in-human, phase 2 proof of concept study aims to show that the formulation at two concentrations is safe and well tolerated over a period of 6 weeks.