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Archive for July, 2011

Ista Pharmaceuticals’ REMURA – Will it bring tears to dry eyes?

Posted by lifetech on July 5th, 2011

Many patients seek to find relief, not from their tears, but rather from their dry eyes. But the answer to their problem is as complex as the tears they lack.

Several structures within the eye are involved in the production of the tear film, which is actually comprised of three layers. These are a basal mucous layer that aids the distribution of tears across the surface of the eye, a middle aqueous layer, and an outer oily layer that slows evaporation of the middle layer. Lacrimal glands, meibomian glands, tear ducts, and eye lids all play a role in the production and elimination of tears. Disease in any of those structures can affect the quality and quantity of tears which ultimately serve to protect the surface of the eye. Patients afflicted with dry eye suffer from an ongoing sense of ‘grittiness’ and eye irritation. In severe cases, the cornea becomes damaged, predisposing to ulceration, infection, and loss of vision.

ISTA seeks to fill the unmet need in dry-eye syndrome with REMURA, a new proprietary formulation of bromfenac. Bromfenac is a non-steroidal anti-inflammatory agent that ISTA has marketed in an earlier 0.09% form for use in the setting of cataract surgery – first branded as Xibrom for twice-daily use and now as Bromday for once-daily use. The new REMURA formulation uses a lower concentration of bromfenac and may have sustained release properties. It is currently under study in two phase III dry-eye trials.

The rationale for use of an anti-inflammatory agent such as an NSAID in dry eye seems strong, as evidence suggests that inflammation plays a central role in dry-eye syndrome, whether as the initiating cause or in response to irritation and damage caused by a reduction in the volume and/or quality of tears. However, a strong mechanistic rationale does not always guarantee program success. And the history of dry eye therapies is littered with failures. Explore the reasons for these failures and their relevance (or lack of thereof) to the REMUARA program through our latest report.