Anti-Inflammatory Program

PolyActiva has developed a proprietary delivery system for the delivery of non-steroidal anti-inflammatory drugs (NSAIDs).  The delivery system involves the formation of polymeric NSAID prodrugs that can be engineered as rod-shaped implants for ocular use or as a viscous gel for intra-articular use.  NSAIDs have analgesic and anti-inflammatory activity.  The mechanism of activation is thought to be through the inhibition of cyclooxygenase (COX) enzymes, essential in prostaglandin production.  Prostaglandins inhibit aggregation of blood platelets, induce vasodilation, increase vascular permeability, and stimulate leucocytosis.

Osteoarthritis

Osteoarthritis (OA) is a degenerative disease characterised by loss of cartilage, joint pain and disability. OA is one of the most common forms of arthritis and is a leading cause of disability globally. OA can affect any joint of the body including the knees, hips, spine and finger joints, but most commonly the knees and hips. GlobalData estimated the osteoarthritis market across the seven major markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is forecast to rise from $3.25 billion in 2014 to $10.49 billion by 2024 with a compound annual growth rate (CAGR) of 17.8%.  This growth is primarily attributed to the ageing population and a rapid increase in the obese population.  The US remains the largest market for osteoarthritis therapeutics, it is forecast to grow from USD 5.1 billion in 2015 to USD 5.8 billion by 2022 at a CAGR of 1.95%.

Existing treatment options are sub-optimal and range from NSAID therapy, viscosupplementation to joint replacement. Many of the currently used pharmaceutical therapies (e.g. NSAIDs) are associated with severe side effects.

PolyActiva is developing a fully biodegradable intra-articular delivery system that is small enough to be administered directly to an arthritic joint through a 23G needle to treat osteoarthritis. Once administered, the product reverts to a deformable gel and using our proprietary NSAID-polymer conjugate technology, the gel will release a NSAID over a period of 1 to 3 months. The intra-articular product is designed to substitute for chronic daily oral NSAID administration. The implant is designed to be administered by a clinical specialist in an outpatient setting. The PolyActiva’s intra-articular NSAID product provides a new treatment modality for osteoarthritis, by providing the same efficacy as that achieved with oral NSAID therapy but without the side-effect limitations.

Post-Surgical Care (Ocular Surgery)

NSAIDs have been shown to help reduce postoperative pain and inflammation, and its effective in reduce the risk of postoperative cystoid macular oedema (CME) following cataract surgery.  Following ocular surgery, the patient is instructed to use anti-inflammatory eye drops for up to six weeks, depending on the inflammation status of the eye. The eye surgeon will judge, based on each patient’s idiosyncrasies, the length of time to continue use of the eye drops.

PolyActiva is also developing a fully biodegradable ocular implant that will release ketorolac over a period of 30 to 45 days based on our proprietary NSAID-polymer conjugate technology.    The implant is administered by the surgeon at the point of ocular surgery.  Two forms of the product will be made available, one designed to administer the implant through the surgical incision by means of a bespoke administration device fitted with a blunt-tipped 23G Rycroft cannula, the other designed to administer the implant by clear corneal or trans-scleral injection by means of a bespoke administration device fitted with a sharp-tipped 23G needle. In both cases, the implant fits in the lumen of the cannula or needle. This implant is designed to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery, corneal refractive surgery, or retinal injections.

PolyActiva has also developed a levofloxacin / ketorolac combination product to provide complete dropless post-surgical care.