NPI-002 Phase 1/2 Trial: First Patients Implanted in Final Cohort for Cataract Delay

Nacuity Pharmaceuticals, a biopharmaceutical firm specializing in treatments for oxidative stress-induced ocular diseases, has reported the initiation of the final participant group in its Phase 1/2 clinical trial for NPI-002. This molecule, an antioxidant delivered through a sustained-release implant, is being trialed for its potential to delay cataract progression in adults undergoing vitrectomy.

The trial, known as NP-2, is a randomized, controlled, and masked study that has received a positive safety review from an independent Data Safety Monitoring Board. This endorsement has been approved by the overseeing Human Research Ethics Committee, paving the way for the final cohort to begin enrolling patients.

Robert Casson, the principal investigator and a professor at the Royal Adelaide Hospital, highlighted the significance of delaying cataract surgery post-vitrectomy, stating that it can reduce the stress of multiple ocular surgeries in a brief timeframe and enhance surgical outcomes.

Enrollment for the final cohort is taking place at The Royal Adelaide Hospital in Adelaide, South Australia, and at personalEYES in Parramatta, New South Wales, Australia. Halden Conner, Chairman, CEO, and Co-Founder of Nacuity Pharmaceuticals, expressed gratitude for the trial's progress and the contributions of the investigators and participants. He emphasized the company's commitment to evaluating NPI-002's effectiveness in slowing cataract progression and preserving vision.

NPI-002 is a novel slow-release small molecule developed to decelerate cataract development. It has been formulated into a sterile intravitreal implant equipped with a precision delivery system. Preliminary studies have demonstrated the molecule's sustained release in the vitreous humor and its lack of cytotoxicity. Additionally, NPI-002 has shown the ability to inhibit oxidative-induced cataracts in ex-vivo rat and porcine lenses.

Nacuity Pharmaceuticals is at the forefront of clinical-stage research for oxidative stress-related treatments. The company's therapies are designed to mitigate oxidative tissue damage, a common factor in vision-impairing eye diseases and other chronic conditions. Nacuity operates in Fort Worth, Texas, USA, and Australia, and boasts a wealth of managerial and scientific expertise, as well as support from prominent organizations in the field.