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Valeria Sanchez-Huerta, Enrique O Graue-Hernandez, Alejandro Navas, Hugo Quiroz-Mercado, Spencer Alford, Darius Kharabi, Stephen C Pflugfelder; Results of a Phase 1b clinical trial of KPI-012, a novel secretome therapy, in patients with Persistent Corneal Epithelial Defect (PCED). Invest. Ophthalmol. Vis. Sci. 2022;63(7):3232 – A0267.
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PCED results from the failure of rapid epithelialization and closure within 10-14 days after a corneal injury, even with standard supportive treatment. If left untreated, PCEDs can result in stromal scarring, perforations, secondary infections, ulcerations, and vision loss. KPI-012 topical ophthalmic solution is a novel, bone marrow derived mesenchymal stem cell (MSC) secretome with a multifactorial mechanism of action that has the potential to treat PCED of various etiologies. In preclinical studies KPI-012 has demonstrated the ability to accelerate corneal wound healing and reduce scarring, inflammation, and angiogenesis. The purpose of this Phase 1b trial was to evaluate the safety and efficacy of twice daily (BID) KPI-012 for the treatment of PCED.
A prospective, single-arm, Phase 1b trial enrolled 12 subjects at two independent sites in Mexico. The initial safety cohort consisted of 3 subjects with low vision and no active corneal disease. KPI-012 was administered BID for 1 week and subjects were followed for 1 week. The efficacy cohort consisted of 9 subjects with PCED of various etiologies. In this cohort, KPI-012 was administered BID for up to 8 weeks and followed for up to 18 weeks. The key efficacy endpoint was complete healing of corneal defects evaluated by corneal staining. Other efficacy endpoints included reduction in defect size, visual acuity, corneal neovascularization, and opacity. The safety measures included tolerability/pain, intraocular pressure, vital signs, and adverse events.
In the efficacy cohort, 6 of the 8 subjects had complete healing of their PCED. There was one early withdrawal unrelated to the KPI-012 treatment in the efficacy cohort. Among the 6 completely healed subjects, four achieved complete healing after one week of treatment, one after two weeks, and one after four weeks of treatment. Improvement in PCED was observed in one subject but complete healing was not achieved. All subjects with complete PCED resolution remained healed through end of their follow-up periods. KPI-012 was well-tolerated with favorable safety profile in both the safety and efficacy cohorts.
KPI-012 topical solution administered twice daily for up to 8 weeks appeared safe, well-tolerated, and effective in the treatment of PCED with various etiologies.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.
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