Abstract
Purpose :
Corneal epithelial defects are termed persistent epithelial defects (PEDs) when they have not healed in 14 days. There are various etiologies of PEDs, and therapy begins with targeting the cause of the condition. Frequently, this treatment and other standard therapeutics for the treatment of this serious condition are unsuccessful. ST266 (Noveome Biotherapeutics, Inc.) is the secreted solution of physiologic growth factors and cytokines derived from a novel population of human amnion-derived cells. In rabbit models of corneal incision and abrasion, ST266 reduced inflammation, decreased neutrophil infiltration and facilitated corneal re-epithelialization. Phase 1 and 2 clinical studies have shown ST266 to be safe and well tolerated in dry eye and allergic conjunctivitis.
Methods :
In this Phase 2, multi-center, open-label clinical trial (NCT 03687632), patients with a PED that met inclusion and exclusion criteria were given ST266 four times daily for 28 days. All eyes had been managed with a variety of standard treatments for PED prior to study entry without success. The primary efficacy endpoint is the percent of eyes with complete healing of the PED within 28 days of treatment, and the secondary safety endpoint is the incidence of adverse and serious adverse events throughout the 28 days of treatment. The persistence of healed PED one week after the end of treatment will also be assessed.
Results :
Five eyes have been enrolled with a mean PED duration of 42.8 days. The PEDs in 2 eyes were healed by day 28 and remained healed at the end of the study on day 35. No adverse events were seen in these subjects. In another eye, the PED healed by day 21, but then re-opened at day 28. By day 35, the defect was nearly closed at 0.2mm x 0.2mm. In the fourth eye, there was some improvement, but the PED did not heal by day 28. The fifth patient withdrew from the study at day 4 due to ocular pain unrelated to the ST266.
Conclusions :
Early results of this Phase 2 study suggest that ST266 may be effective in healing some PEDs that have been recalcitrant to other standard therapies. Three of 4 patients saw complete healing during the 28-day treatment with one out of the three re-opening. ST266 was well-tolerated by the patients. Continued evaluation of this therapeutic agent is necessary to confirm its safety and efficacy for treating PED.
This is a 2020 ARVO Annual Meeting abstract.