for treatment of Retinitis Pigmentosa in Usher syndrome
In preclinical animal studies, NPI-001 preserved photoreceptor cells and functionality. A Phase 1 clinical trial of Nacuity’s GMP-grade NPI-001 solution in healthy volunteers was completed with acceptable results.
A randomized, placebo-controlled, double-masked, multicenter, Phase 1/2 clinical trial of Nacuity’s proprietary NPI-001 tablets, the SLO-RP Study, is enrolling patients with RP associated with Usher syndrome (NCT04355689). Nacuity expects to report interim results from this study during the fourth quarter of 2022.
This product has been granted orphan drug designation, thus, an eligible new drug application would result in 7 years of U.S. FDA regulatory exclusivity for Nacuity.
NPI-002 Intravitreal Implant
for prevention or treatment of cataract
Nacuity has developed a prototype intravitreal implant loaded with a small antioxidant molecule, NPI-002, to slow cataract progression plus a proprietary injector. Nacuity has completed non-clinical testing, has received HREC approval for and expects to initiate a Phase 1/2 clinical study in Australia of NPI-002 during the fourth quarter of 2021.
NPI-001 Ophthalmic Insert
for the treatment of ocular effects of Cystinosis
Nacuity has developed a prototype ophthalmic insert containing a small molecule antioxidant for the treatment of ocular effects of cystinosis. In vivo nonclinical studies with the insert reveal that significant levels of drug can be delivered to the aqueous humor daily by wearing the ophthalmic insert under the eyelid. Nonclinical evaluation continues as a prelude to clinical studies. This product has been granted orphan and rare pediatric disease designations, thus, an eligible new drug application would result in 7 years of U.S. FDA regulatory exclusivity and a priority review voucher for Nacuity.