- SmartCelle TA-A001 A Treatment for Ocular Inflammation and Pain
- SmartCelle TA-A001 An Intravenous Analgesic for Acute Postoperative Pain
A Treatment for Ocular Inflammation and Pain
Cataracts are the most frequent cause of age-related blindness in the world and each year surgeons in N.America and Europe perform over 7 million operations to remove them. Refractive surgeries (e.g. PRK and LASIK surgery) add another 2 million patients and all indications are growing as populations age.
Any incision in the eye causes pain and inflammation. While topical NSAID and corticosteroids may be enough for some patients, for those with moderate to severe pain (up to 35%) they are not. Sadly there is an increasing trend to treat these patients with opioids; intravenous fentanyl often being employed.
Cataract surgery frequently leads to dry eye syndrome (DES) a chronic condition causing stinging, burning and itching of the eyes which can lead to blindness. 18 million people in N.America today suffer DES today and current treatments are often ineffective and poorly tolerated.
TA-A001 offers now hope to those with eye pain and DES. After topical instillation, TA-A001 displayed potent dose-dependent analgesia in a ‘hyperalgesia’ model of ocular pain and strongly inhibited the migration of pro-inflammatory immune cells to the injured site breaking the pro-inflammatory cycle. The efficacy of TA-001 in this model was significantly greater than those of all cannabinoid drugs. TA-A001 was delivered to the surface of the eye using SmartCelleTM technology
TALLC will demonstrate the efficacy and safety of TA-A001 in Ph II human Proof-of-Concept study of dry-eye disease.
An Intravenous Analgesic for Acute Postoperative Pain
Around 70 million surgeries are performed annually in N. America, 80% of which are elective and performed in Ambulatory Surgery Centers (ASC). Postoperative pain remains the most prominent concern for these patients and all receive intravenous analgesia during and after surgery to combat this. In 4/5 cases analgesia is provided by opioid drugs despite opioids distressing side effects, potential for higher death rates and increased hospital stay times. These factors are in addition to the catastrophic societal impact of opioid use in N. America and the 500,000 overdose deaths that have occurred from opioid overdose in the last number of years; 6% to 7% of patients receiving opioids after surgery become persistent users.
TA-A001 is a non-opioid, non-steroidal small molecule that selectively activates the CB2 receptors mediating the human inflammatory response; unlike CB1 activators, or opioids, CB2 receptor activation produces no dependency, euphoria or psychedelic effects; animal studies suggest CB2 activation can inhibit addictive behaviour.
Bolus i.v. administration of TA-A001 to animals 1hr after incisional surgery produced immediate and long lasting (6/8 hrs) analgesia at doses one tenth of those required for NSAID or COX-2 drugs given i.v. Efficacy was increased if TA-A001 was administered immediately before surgery and the drug was well tolerated at all doses.
These studies demonstrate the potential of TA-A001 to replace opioid treatment of postoperative pain while it’s lack of COX-1 activity (and cardiovascular and bleeding risks) and superior efficacy supports it as a replacement of non-opioid analgesics also. TALLC will demonstrate the efficacy and safety of TA-A001 in Ph II human Proof-of-Concept bunionectomy study.
Enhanced Ocular Delivery of TA-A001
Tetra Bio-Pharma and Altus Formulation Form New Company “TALLC” to Exploit TA-A001
© TALLC Inc. 2020