Clinical Safety and Efficacy Data of DSP-Visulex Published in Current Eye Research
Aciont Inc. announced today that data from the clinical study of the DSP-Visulex technology is published online ahead of print in Current Eye Research. Reference: Papangkorn K, Truett KR, Vitale AT, Jhaveri C, Scales DK, Foster CS, Montieth A, Higuchi JW, Brar B, Higuchi WI. Novel dexamethasone sodium phosphate treatment (DSP-Visulex) for noninfectious anterior uveitis: a randomized phase I/II clinical trial. Current Eye Research.
Dr. Kongnara Papangkorn, VP of Product Development at Aciont, is the first author of the publication. “We are pleased to publish our Phase 1/2 clinical data of DSP-Visulex in Current Eye Research, a reputable peer reviewed journal. In this study, we randomized 44 patients to compare high and low strengths of DSP-Visulex against prednisolone acetate eye drops, the standard of care,” said Papangkorn. "We found that 4 or 5 doses of DSP-Visulex provided the same efficacy results to 112 drops of prednisolone acetate, without IOP elevation. Both DSP-Visulex treatment modalities also appear to be safe and well tolerated," Papangkorn added.
Dr. Balbir Brar, VP of Research and Development added, “This was the first clinical study of DSP-Visulex. It reemphasizes the potential of DSP-Visulex for the treatments of eye diseases including uveitis as well as post-operative inflammation and pain. Although this study is small, the steroid treatment without IOP increase could benefit a wide range of eye disease patients especially glaucoma and diabetic or elderly patients who are more susceptible to IOP increases.”
“With these positive outcomes, we are looking to expand the DSP-Visulex indication to posterior eye disease indications such as macular edema where more patients can benefit from this unique treatment,” said John Higuchi, CEO.
Papangkorn K, Truett KR, Vitale AT, Jhaveri C, Scales DK, Foster CS, Montieth A, Higuchi JW, Brar B, Higuchi WI. Novel dexamethasone sodium phosphate treatment (DSP-Visulex) for noninfectious anterior uveitis: a randomized phase I/II clinical trial. Current Eye Research. Published online November 15, 2018. The abstract and full article can be found in the journal and on the publisher’s website:
About DSP Visulex
DSP-Visulex is a noninvasive drug delivery system of dexamethasone sodium phosphate (DSP). It utilizes a combination of a proprietary high concentration DSP solution and Visulex-P drug delivery technology to enable a simple administration of DSP to treat inflammation conditions of both anterior and posterior eye tissues. Visulex-P is based on passive diffusion to deliver small molecules such as most generic corticosteroids and immunosuppressive agents whereas DSPV-201 is a multicenter, randomized, parallel group, double-masked, active-controlled study of DSP-Visulex in noninfectious anterior uveitis patients. DSP-Visulex therapy (two applications on the first week then weekly after) was compared to daily prednisolone acetate 1% eye drops. The study was supported by two phase 2 NEI SBIRs, reference by Grant R44EY014772, and the clinical study is registered at clinicaltrials.gov under identifier NCT02309385.
Aciont Inc. is a mid-clinical staged, specialty biopharmaceutical company located in Salt Lake City, Utah. Our Visulex noninvasive drug delivery technology platforms endeavor to advance therapeutics in ophthalmology. Our world-renowned research team is focused on developing noninvasive therapeutics for sight threatening diseases affecting both the anterior and posterior sections of the eye addressing a potential wide range of ocular diseases and drug transport challenges. Our lead clinical staged product, DSP-Visulex, addresses key ocular inflammation related indications such as severe uveitis, post-operative pain/inflammation and macular edema.