New drugs update: Argentis ARG101(T), ARG102(P)

I received an update from Argentis last week on their two hormone-type therapies in the pipeline. I think this is an interesting area and would like to better understand the potential applicability to chronic meibomian gland dysfunction, which seems to be the root of dry eye for many of us.

We now have in-licensed two therapies to treat dry eye syndrome (DES), ARG101(T) and ARG102(P) from the Southern College of Optometry (SCO). The patent for ARG101(T) was issued in December 2003. In December 2006, arGentis submitted a patent application for ARG102(P). Both therapies provide for transdermal delivery of the active pharmaceutical ingredient through application of a cream or gel formulation to the upper and lower eyelids, and a mechanism of action that restores the natural process of tear production.

ARG101(T) is a testosterone cream or gel formulation used to treat DES in menopausal women. Waning androgen levels in women before, during, and after menopause has been identified as a primary cause of DES. ARG101(T) is unique in that it is applied to the upper and lower eyelids for transdermal delivery of testosterone directly to the affected glands. Our research shows by delivering the active pharmaceutical ingredient transdermally allows better access to the glands and enables convenient twice-daily dosing. ARG101 (T) restores aqueous and lipid production thereby restoring the natural process of tear production.

ARG102(P) is a progesterone cream or gel formulation used to treat DES in men and younger women. The cross-reactivity between progesterone and corticosteroid receptors in the ocular region is believed to activate corticosteroid anti-inflammatory activity in the glands and on the ocular surface, restoring normal aqueous and lipid production. ARG102 (P) is also applied to the upper and lower eyelids for transdermal delivery of progesterone directly to the affected glands.

Although ARG101(T) and ARG102(P) have different active pharmaceutical ingredients and treat different populations of DES patients, they share several characteristics which make them unique among current DES therapies and those in development:

A patient-friendly application with a cream or gel formulation to the upper and lower eyelids versus conventional drop application.
Transdermal delivery of anti-inflammatory hormones directly to the affected glands.
Restores the natural process of tear production versus tear replacement of conventional therapies.
Convenient twice-daily dosing versus the frequent applications required by tear replacement therapies.
No stinging or burning of the skin to which it is applied or of the ocular surface.

Moving forward, arGentis intends to begin a Phase I/II trial in 2007 to confirm the results that have been achieved with their use in clinical practice at the Southern College of Optometry. We expect the trial to begin in Q4:07 with results available in Q1:08.

Here's a link to their pipeline page for full details.