Postoperative infectious endophthalmitis is one of the most feared complications of ocular surgery. Although rare, the complications from endophthalmitis can be catastrophic with irreversible damage to the retina and resultant visual loss. Common causative agents of bacterial endophthalmitis include Staphylococcus aureus, S. epidermidis, Pseudomonas aeruginosa and Streptococcus spp.. Consequently, the patient is instructed to use anti-inflammatory and antibiotic eye drops after surgery for up to two weeks. While the application of anti-inflammatory and antimicrobial agents remain the gold standard of post-surgical care, the success of such therapy can be hampered by inconsistencies in patient compliance, surgical complications, and poor ocular penetration by administered agents.
The eye surgeon will judge, based on each patient’s idiosyncrasies, the time length to use the eye drops. Following ocular surgery, the eye will be mostly recovered within a week, and complete recovery should be expected in about a month.
To overcome these challenges, PolyActiva has engineered biomaterials for implantation to enable the delivery of therapeutic agents directly to the site of infection; and which are designed to degrade over time so that the removal of the implanted device is unnecessary. The implant is administered through the surgical incision with a bespoke administration device. The rod-shaped ocular implant fits in the lumen of the needle or cannula fitted to the administration device. It starts to deliver a constant daily dose of levofloxacin (a fluoroquinolone antibiotic) for a period of at least 5-days, starting within hours of administration. The implant is designed to biodegrade as soon as possible after the treatment period and biodegrades into safe and non-toxic by-products, leaving no residue. The implant comprises a single biomaterial (levofloxacin polymeric prodrug) engineered from PolyActiva’s polyurethane-ester system.
PolyActiva has developed a preventive implant based on our proprietary polyurethane ester delivery system that is fully biodegradable, and will release levofloxacin over a period of at least 5-days and biodegrades within 60-days into safe and non-toxic by-products. In the case of cataract surgery, the implant is administered by the surgeon immediately after placement of the new intraocular lens and immediately prior to closing. The implant can be administered through the primary or secondary incision with a bespoke administration device fitted with a blunt tipped 23G Rycroft cannula. The implant can be used to prevent and/or to substitute for the frequently administered drops associated with postoperative care following cataract surgery. Two forms of the product are under development, one that delivers the fluoroquinolone antibiotic, levofloxacin, and a combination product of levofloxacin and steroid.
PolyActiva is also developing a fully biodegradable treatment implant that can be used to treat an established endophthalmitis infection. This implant releases a combination of levofloxacin and steroid over a period of at least 5-days and biodegrades within 60-days into safe and non-toxic by-products. The implant is administered by trans-scleral injection with a bespoke administration device fitted with a sharp-tipped 23G needle.