Patients undergoing vitrectomy are highly likely to develop significant cataracts after their surgery and the majority of them require cataract surgery within a year of the vitrectomy. Delaying that subsequent surgery can improve surgical outcomes and alleviate the stress of having two ocular surgeries in a short period of time. Nacuity Pharmaceuticals, Inc. (www.nacuity.com), a clinical stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other ocular diseases caused by oxidative stress, is conducting a Phase 1/2 Proof of Concept study in Australia (NCT05026632) to assess the safety and efficacy of a novel intravitreal treatment NPI-002 for the delay of cataract progression in patients undergoing vitrectomy.
NPI-002 is a small antioxidant molecule delivered via a sustained release intravitreal implant. To delay the progression of cataracts following vitrectomy, NPI-002 is implanted into the vitreous during vitrectomy surgery. In vitro and in vivo studies have shown elution of NPI-002 into the vitreous over time with no associated cytotoxicity. In studies of ex-vivo rat and porcine lenses, NPI-002 inhibited oxidative-induced cataracts.
To delay the progression of cataracts following vitrectomy, NPI-002 is implanted into the vitreous during vitrectomy surgery
Phase 1/2 Study Underway
The first part of the Phase 1/2 randomised, controlled, masked clinical trial assessing the safety and efficacy of NPI-002 in delaying cataract progression in patients undergoing vitrectomy is currently underway at The Royal Adelaide Hospital in Adelaide, South Australia, and personalEYES in Paramatta, New South Wales.
“While cataracts are the leading cause of blindness worldwide, patients remain underserved as no approved drug therapies to slow progression currently exist, and the only treatment option is surgery,” said Robert Casson, MBBS (Hons), DPhil, principal investigator of the trial and Professor, Royal Adelaide Hospital. “Oxidative stress plays a critical role in the onset and progression of cataracts and may be reduced using NPI-002, a differentiated antioxidant therapy.”
To date, six out of nine patients in the first study cohort have been enrolled in the clinical trial. Two patients have completed the study, which involves six post-operative follow-up visits over nine months, and no serious adverse events have occurred. Full enrolment of 30 patients across both clinical sites is targeted by the end of 2023, with clinical proof of concept data expected by mid-2024. Lens densitometry image analysis will be used to assess cataract progression in subjects who receive the implant versus control subjects (no implant).
“Cataracts adversely affect a person’s quality of life, causing blurry vision, glare and faded colours. Unfortunately, patients over the age of 50 who undergo vitrectomy surgery experience accelerated cataract progression,” said Nancy Holekamp, M.D., Director of Retina Services at Pepose Vision Institute in Chesterfield, MO, USA and member of Nacuity’s Scientific Advisory Board. “With this in mind, we designed the Phase 1/2 trial of NPI-002 to confirm and build upon the encouraging preclinical data and to ultimately offer patients a novel, safe and efficacious treatment option to slow the progression of cataracts.”
Patients Needed for Study
If you have a phakic patient who requires vitrectomy surgery and might like to participate in this study, please contact Kylie Dansie at Royal Adelaide Hospital (Adelaide) [email protected] or Anna Siu at personalEYES (Parramatta) [email protected] for further information.
