Abstract
Rescula (unoprostone isopropyl) has been in the market as ocular hypotensive drug since 1994. There are amounting scientific research and post-marketing clinical experiences reported in peer review journals. Yet there seems limited understanding about its unique clinical implication associated with newly discovered molecular mechanism (traits) of BK channel activation. Hence this review article is using a focal lens with an eye on B-K channel activation to further delineate possible roles of rescula in modulating chronic parainflammation in the eye, which may eventually set it apart from the rest lipid hypotensive drugs such as latanoprost that is pro-inflammatory in nature. Cystoid macular edema and refractory glaucoma will be the key historical clinical case highlights.
Highlights
Rescula was the first docosanoid lipid hypotensive drug approved for the treatment of open-angle glaucoma (OAG) and ocular hypertension (OH) in Japan (R-Tech Ueno Ltd) in 1994, followed by the US approval (CIBA Vision/Novartis AG) in 2000, but it was shortly pull off the USA market by Novartis AG in 2005
As we closely examined the details of food and drug administration (FDA) label, safety warning of rescula on cystoid macular edema (CME) and other inflammatory condition seems rootless, which is contradicting with its anti-inflammatory nature
As a B-K channel activator, the potential benefits of anti-inflammatory and neuroprotective functions may open up a broad therapeutic niche window to those whose glaucoma pathological identities involve with a complex chronic ocular inflammatory process, such as refractory glaucoma, or a combination of glaucoma with other ocular inflammatory conditions
Summary
Rescula (unoprostone isopropyl) was the first docosanoid lipid hypotensive drug approved for the treatment of open-angle glaucoma (OAG) and ocular hypertension (OH) in Japan (R-Tech Ueno Ltd) in 1994, followed by the US approval (CIBA Vision/Novartis AG) in 2000, but it was shortly pull off the USA market by Novartis AG in 2005. One of the purposes for this review is to provide indepth scientific analysis about the root causes of these three old CME cases in hopes of offering evidence-based suggestion for future consideration on FDA label amendment as appropriate, more importantly, it may clear up the barrier to reposition rescula as a new molecular entity (not prostaglandins) with unique therapeutic potential for glaucoma patient care.
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