A drug-infused hydrogel implant for glaucoma drainage devices

Unmet Need

Glaucoma is an ocular disease involving heightened eye pressure most commonly leading to blindness, affecting roughly 3 million Americans. Current treatments include anti-steroidal or anti-inflammatory drugs to remove excess ocular fluid or decrease its production, lasers to drain eye fluid more precisely, and surgery to create conduits for fluid drainage. Glaucoma drainage device (GDD) implants are one such surgery-guided therapy which serve to shunt excess fluid from the front of the eye. However, these surgeries often cause inflammation and pain while also increasing intraocular swelling during healing. There is also low patient adherence on eye drop dosing (high drop burden), exacerbating undertreatment in large patient populations and rendering drug therapy ineffective. Thus, there is a need for new methods of mitigating surgery-induced complications and potentially improving patient adherence to eye drop/drug therapy.

Technology

Duke inventors have developed a drug-infused hydrogel implant for use with GDD implants. This is intended to be used by surgeons during GDD implantation for the ~20% of glaucoma patients utilizing drainage devices for their treatment. Specifically, PEG hydrogel infused with a steroidal drug is implanted within the lumen of a GDD tube, after which the drug can diffuse slowly over time and reduce the need for patients to continually apply eye drops. This technology removes the need for a rip cord for tying off the GDD. This is an important differentiation as rip cords can lead to complications such as erosions within the conjunctiva and creating conduits for infection. However, the hydrogel implant can be used in conjunction with a rip cord if necessary, providing a fail-safe as a precaution. This has been demonstrated in vitro where the device was characterized for structural stability when subject to pressures equivalent to those observed in the eye. The inventors also demonstrated the successful integration of the rip cord into their device, to be used if needed.

Advantages

• Can reduce drop burden for glaucoma patients undergoing treatment
• Localized steroid release prevents off-targets and can help prevent fibrosis at site of GDD
• Surgical operating time is reduced based on lack of need for tube tying
• Could infuse multiple drugs into the hydrogel to promote healing and fluid removal