Successful management of dry eye disease with a new eye drop formulation combining hyaluronic acid, trehalose, and N-acetyl-aspartyl-glutamic acid (NAAGA)

Purpose - To assess the clinical efficacy and safety of T2769, a new preservative-free eye drop combining hyaluronic acid (HA), trehalose and N-acetyl-aspartyl-glutamic acid (NAAGA), in dry eye patients. Patients and methods - This was a multicenter, non-comparative, open-label study. After a run-in period with NaCl 0.9% solution, 62 patients with moderate-to-severe dry eye disease (DED) were included and treated with T2769, 3 to 6 times/day for 42 days. The primary efficacy endpoint was the change in global ocular symptomatology assessed on a visual analog scale between Day 1 (D1) and D42. Other efficacy endpoints included ocular surface disease index (OSDI), soothing sensation, individual dry eye symptoms, conjunctival hyperemia, global ocular staining, tear break-up time, Schirmer test, and global efficacy assessed by the investigator. Safety was assessed throughout the study. Results - A marked reduction in ocular symptomatology was observed from D1 to D42 with a mean change of -55.9 +/- 23.1 mm (P < 0.001). This was accompanied by a mean change in OSDI score from baseline of -44.6 +/- 15.9 (P < 0.001) and a substantial soothing sensation in 82.3% of patients. Clinically significant improvements were observed for all ocular symptoms (mainly burning/irritation, stinging/pain, feeling of ocular dryness, foreign body sensation, itching/pruritus). Conjunctival hyperemia significantly decreased in 96.8% of patients (56.5% displayed no conjunctival hyperemia at D42 versus 0% at baseline). All signs and symptoms improved by D14 and further improved at D42. Investigators assessed the ocular efficacy of T2769 as very satisfactory or satisfactory for 91.9% of patients at D42. T2769 was well tolerated, with no ocular adverse events and only a few ocular symptoms upon instillation. Conclusion - Management of moderate-to-severe DED patients with the new formulation T2769, combining NAAGA to HA and trehalose, led to rapid and significant improvements in dry eye signs and symptoms with good tolerability. (c) 2024 Published by Elsevier Masson SAS.