HyaGuard is a biodegradable, sub-conjunctival drug-delivery system designed for glaucoma filtration surgeries (such as trabeculectomies and microshunts).
It is a 3D-printed mesh structure surrounded by a hyaluronic acid hydrogel. It can be inserted into a sub-conjunctival pocket quickly during surgery. The insert is designed to fit current surgical protocols without needing additional tissue glue or sutures.
A preliminary study to assess the feasibility of the HyaGuard™ sub-conjunctival drug-delivery system in conjunction with the PRESERFLO™ MicroShunt (PFMS) was presented at the 2026 ARVO Annual Meeting, held in Denver, CO, May 3-7, 2026.
Methods : 5% w/w dexamethasone loaded HyaGuard™ units were fabricated by LEP Biomedical to create a 3D printed mesh surrounded by a hyaluronic acid hydrogel. HyaGuard™ units were freeze-dried and ethylene oxide sterilized prior to use. Commercially available PFMS were obtained from InnFocus Inc. and implanted in a sub-conjunctival pocket six female New Zealand white rabbits (3.0-3.9kg) using a standard procedure without the use of Mitomycin C. HyaGuard™ units were hydrated with balanced saline solution prior to implantation and were placed juxtaposed to the PFMS tube prior to the closure of the subconjunctival flap. Ophthalmic evaluations were performed at post operative days 1,3, 7, 14, 21 and 30. Ocular surface, bleb morphology, anterior chamber and intraocular pressures (IOP) were recorded. All procedures and time-point evaluations were conducted in accordance with the approved IACUC protocol.
Results : All six female rabbits appeared healthy throughout the study with no signs of distress, infection or intraocular inflammation. In the early post-operative period, grade I hyphema was observed (6/6) and central endothelial folds were observed (1/6) in one but resolved by week 2 without further complications. Histological analysis at 1 month confirmed the local tolerability of the HyaGuard™ units.
Despite not using Mitomycin C as an anti-fibrotic drug during the PFMS implant, blebs were observed in 2/6 rabbits (33%) after one month indicating the potential of the HyaGuard™ unit to maintain a bleb. Conjunctival swelling was minimal. ≥20% reductions in IOP were achieved up to D14 with a return to baseline by 1 month with a potential dose-response evident.
Conclusions : The HyaGuard™ implant was well tolerated in the rabbit eye in conjunction with the PFMS glaucoma drainage device for one-month showing normal bleb morphology and quiescent healing characteristics. This feasibility study showed that HyaGuard™ is likely safe to use with the PFMS and could potentially replace the use of intra-operative Mitomycin-C.
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