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Abbe Miller, Charles Blizzard, Amar Sawhney, Michael Bassett, Peter Jarrett, Arthur Driscoll, Monica O'Connor, Doug Molla, Steve Takach; Sustained Delivery of Travoprost from a Biodegradable Hydrogel Punctum Plug for the Treatment of Glaucoma. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5633.
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To formulate 1, 2 and 3-month sustained release travoprost from biodegradable hydrogel punctum plugs for the treatment of glaucoma.
Travoprost was encapsulated in various formulations of polylactide microparticles (PM), which were dry blended and suspended in a multi-arm polyethylene glycol (PEG) precursor solution conjugated with fluorescein and injected into small bore tubing prior to cross-linking. The travoprost in the PM/hydrogel matrix was dried in tubing and cut into plugs. Drug release rate from the respective formulations was assessed in PBS at pH 7.4 at 37 C until complete dissolution. The 3-month formulation was evaluated for plug visualization through the tissue in a canine model under illumination with a blue light and yellow filter.
Sustained release of travoprost via PEG hydrogel punctum plugs was confirmed in vitro for each of the three formulations tested (Figure 1). Additionally, each formulation released a daily dose (based on in vitro release data) exceeding that administered by commercially available travoprost eye drops. Visualization and retention of the plug was confirmed in vivo (Figure 2).
1, 2 and 3-month sustained release of travoprost from biodegradable punctum plugs is feasible, and can deliver travoprost into the tear fluid at therapeutic levels. Plug retention is a key attribute to achieve clinical success, and confirmation of plug presence can be done by physicians and patients for monitoring. In recent clinical trials, the 1- and 2-month formulations demonstrated a reduction of intraocular pressure (IOP) in patients with glaucoma and ocular hypertension comparable to commercially available topical prostaglandin analogs.
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