Abstract
Purpose :
Aim of our research was to develop an ophthalmic eye drops (MDV1601) able to intervene in any event of “dry eye cascade” as defined by DEWS II, by employing two endogenous molecules, Palmitoylethanolamide (PEA) and Docosahexaenoic acid (DHA), showing well documented neuro-regenerative and anti-inflammatory activities and which are very difficult to stabilize in a safe eye drops.
Methods :
MDV1601 shelf-life stability studies were performed in two different final packaging: LDPE bottle (10mL) with ODS system and single-dose pouches (0.5 mL) according to International Conference on Harmonization (ICH) stability guidelines: 25°C (±2°C/ NMT 60% R.H) and 40°C (± 2°C/ NMT 75% R.H). Safety of the new patented formulation was evaluated by cellular viability using an in vitro human corneal cells model (HCE-SkinEthic), through MMT assay.
Results :
MDV1601 is an isotonic and safe eye drop solution preservative free. PEA and DHA are highly stable for 6 months at 40° and for at least 24 months at 25°C, meeting ICH stability requirements for the storage at room temperature. The MMT results after 30 min (irritation test) and 24h (cytotoxicity test) of MDV1601 contact time suggested absence of direct toxicity and no epithelial surface damage (viability >98% versus negative control-PBS).
Conclusions :
MDV1601 is the first formulation based on two very active endogenous molecules (PEA and DHA) potentially able to stabilize tear film and to protect ocular surface in dry eye syndrome, in line with the DEWS II definition of dry eye. The presence of PEA+DHA combo links anti-inflammatory and neuro-regenerative activity potentially able to improve signs and symptoms of the disease. Moreover, the absence of preservatives may result in improved ocular safety. MDV1601 could represent the “ideal artificial tear” for physiological restoration of ocular surface in dry eye syndrome.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.