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Abstract

The invention relates to soluble melatonin tripartate adduct comprising three structurally distinct regions and optionally trehalose, its stable sterile lyophilized powder and preservative-free aqueous solution or ointment, and to related pharmaceutical forms thereof, wherein the active melatonin moiety is adducted to a nucleoside in an optimal ratio range, with or without the presence of C₂-C₅ short chain amino acid. The invention further relates to the pharmaceutical field, more precisely it refers to the ophthalmic use of said melatonin tripartate adduct and to the method to prevent or treat serious ophthalmic pathologies in mammals and humans, more precisely rare and severe eye sight-threatening conditions and neuro-ophthalmic disorders in human and veterinary medicine, wherein said acute and chronic pathophysiological alterations and oculopathies are mainly caused by oxidative stress and related hypoxia-inducible factors (HIFs) and inflammation affecting the eyes. The pharmaceutical composition of said melatonin tripartate adduct may optionally contain either retinol or sodium hyaluronidate, or hyaluronic acid, L-carnosine, L-acetylcarnosine or a mixture thereof. Viscosity enhancers may be optionally included in the composition. Furthermore, the pharmaceutical composition of the invention is chemically and physically stable and safe.

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First Claim