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April, 30 2024 • Articles

Nacuity Pharmaceuticals Announces First Patients Implanted in Final Cohort of Phase 1/2 Clinical Trial Evaluating NPI-002 Intravitreal Implant for the Delay of Cataract Progression

Two patients have been implanted in the final cohort of the trial
Final cohort is actively enrolling adult patients undergoing vitrectomy

FORT WORTH, Texas, April 30, 2024 (GLOBE NEWSWIRE) -- Nacuity Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other ocular diseases caused by oxidative stress, today announced that the first patients have been implanted in the final cohort of the Phase 1/2 clinical trial evaluating NPI-002 for delayed cataract progression in patients undergoing vitrectomy. An independent Data Safety Monitoring Board (DSMB) recommended proceeding with the final cohort after a positive safety review, which was subsequently approved by the overseeing Human Research Ethics Committee.

NPI-002 is a proprietary antioxidant molecule delivered via a sustained release intravitreal implant. The Phase 1/2 NP-2 trial is a randomized, controlled, masked clinical trial assessing the safety and efficacy of NPI-002 in delaying cataract progression in adult patients undergoing vitrectomy.

“Patients typically need cataract surgery within a year of their vitrectomy,” said Robert Casson, MBBS (Hons), DPhil, principal investigator of the trial and Professor, Royal Adelaide Hospital. “Delaying a subsequent cataract surgery after vitrectomy can alleviate the stress of having two ocular surgeries in a short period of time and improve surgical outcomes for patients.”

The final cohort of the trial is actively enrolling patients for clinical sites at The Royal Adelaide Hospital (RAH) in Adelaide, South Australia, and personalEYES in Parramatta, New South Wales, Australia.

“We’re encouraged by the positive safety signals seen to date and we’re grateful for the trial’s progression thanks to the diligent work of the trial investigators and the participation of patients,” said Halden Conner, Chairman, CEO, and Co-Founder of Nacuity Pharmaceuticals. “We look forward to continuing our evaluation of our NPI-002 antioxidant to slow cataract progression and preserve the sight of these patients.”

For more information about the Phase 1/2 clinical trial of NPI-002, please visit clinicaltrials.gov (Identifier: NCT05026632 ).

About NPI-002
NPI-002 is a novel, differentiated, slow-release, small molecule being developed to slow cataract progression. For the treatment of cataract, a sterile intravitreal implant containing NPI-002 has been developed, along with a precision delivery system. In vitro and in vivo studies showed vitreal elution over time and revealed no cytotoxicity with NPI-002. In ex-vivo rat and porcine lenses, NPI-002 inhibited oxidative-induced cataracts. NPI-002 is currently being evaluated in a Phase 1/2 proof-of-concept clinical trial in Australia ( NCT05026632 ).

About Nacuity Pharmaceuticals
Nacuity Pharmaceuticals is a clinical-stage leader in innovative treatments for oxidative stress. The company’s powerful, targeted therapies aim to attenuate oxidative tissue damage, a driver of blinding eye diseases and a broad spectrum of serious chronic conditions. Nacuity has three highly differentiated clinical programs ongoing in retinitis pigmentosa, cataract and inherited cystinosis. Nacuity has operations in Fort Worth, TX, USA, and Australia, and extensive managerial and scientific domain expertise as well as backing from Foundation Fighting Blindness and its venture arm RD Fund. For more information, please visit www.nacuity.com.

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