- SmartCelle TA-A001 For Keratoconus Surgery
- SmartCelle TA-A001
For PRK, LASIK and Cataracts
- SmartCelle TA-A001 For Dry Eye and Glaucoma
Pain Management after Keratoconus Surgery
Keratoconus is a sight-threatening orphan disease characterized by progressive weakening and distortion of the cornea. Affecting up to 200,000 people in N. America the condition may be treated by surgery to strengthen the cornea with a chemical cross-linking agent. While highly beneficial, especially if performed early, before disease progression affects eyesight, the most effective procedures cause excruciating pain as they require removal of the corneal epithelium, a tissue up to 600 times more sensitive than skin.
To use the patient’s own words:
Patient A: “Intense Pain – Narcotics did not work”
Patient B: “I had CXL last Thursday. The pain was excruciating”
Patient C: “The Pain is Horrendous for 24-48hrs”
There is no effective treatment for the pain patients experience today because the delay to wound healing that NSAID drugs cause and the poor efficacy and dependency risks of oral opioids makes these analgesics inappropriate. The anxiety many patients feel about the pain then makes them reluctant to undergo the sight-preserving procedure allowing the disease to progress unabated.
Quoting Dr. Marie-Claude Robert, a leading Canadian Ophthalmologist
“The Pain is Terrible – and We have Nothing for It”.
TA-A001 has no opioid effects and displays potency ten-fold greater than non-steroidal anti-inflammatory drugs (NSAID) in animal models where after topical application it effectively suppresses inflammation and the build up of leukocytes and other immune cells. Most importantly, because of its unique mechanism TA-A001 displays no negative effect on wound healing, reducing infection risk.
SmartCelle TA-A001 represents an effective new approach to meet the unmet needs of keratoconus patients promoting earlier treatment, improved outcomes and more extensive application of the cross-linking procedure.
Photo-Refractive Keratectomy (PRK), LASIK and Cataract Surgery
Photo-Refractive Keratectomy (PRK) and LASIK (Laser-Assisted Keratomileusis) are corneal surgeries performed to correct myopia (nearsightedness) and hyperopia (farsightedness) using lasers to reshape the corneal surface refocussing light properly on the retina. Similar to keratoconus surgery PRK requires removal of the surface layers of the cornea by scraper or stiff brush and it is extremely painful. Despite their drawbacks, topical non-steroidal anti-inflammatory drugs (NSAID) and oral opioid medications are routinely administered to combat pain which lasts for 3-4 days. Steroids are provided to control inflammation
LASIK surgery, developed to avoid the prolonged pain of PRK, requires a penetrating incision to be made through the cornea creating a peel-back flap to expose the sub-surface layers. Corneal nerves controlling tear formation are severed during the procedure so that, like PRK, dry eye lasting 3-4 months, is a common side-effect. NSAID and steroids are prescribed to address the pain and inflammation.
Approximately 700,000 elective PRK and LASIK surgeries are performed each year in North America with older patients with thinner cornea under going more PRK procedures.
Cataracts are a progressive clouding of the ocular lens causing vision loss and blindness if untreated. Cataracts are present in the eyes of over 25 million North Americans today and more than 4 million lens replacement surgeries are performed each year to remove them, a figure that will only grow as populations age. The pain and inflammation of cataract surgery are treated by prolonged application of topical NSAIDs and steroids which, while effective, can delay wound healing and increase pressure within the eye leading to glaucoma. A failure to treat inflammation adequately can cause dry-eye symptoms which can last for many months.
SmartCelle TA-A001 offers the ability to manage the pain and inflammation caused by PRK, LASIK, cataract and other corneal surgeries without the side-effects of opioid, NSAID, and steroid medications.
For Glaucoma and Dry-Eyes
Glaucoma is an optic nerve condition characterized by progressive degeneration of the retina resulting in a progressive vision loss. Glaucoma affects more than 70 million people worldwide and is the leading cause of irreversible blindness. Glaucoma is caused by inflammation and blockage of the channels that drain liquid from the front (the “trabecular meshwork” or TM) leading to an increase in internal pressure that damages the optic nerve. By activating CB2 receptors in the TM SmartCelle TA-A001 can reduce inflammation in these channels restoring liquid flow. Topically applied SmartCelle TA-A001 represents a potential new treatment for glaucoma.
Dry-eye affects approximately 20 million people in N. America those suffering the disease experiencing pain stinging and burning, blurred vision and painful light sensitivity. Inflammation has been recognized as a major factor both in causing dry eye and in maintaining the disease which is characterized by an increase in immune cell numbers in the conjunctiva and cornea.
When applied to the surface of inflamed eyes TA-A001 reduces immune cell build up, reduces pain and reduces levels of inflammatory mediators. Topically applied micellar TA-A001, with its unique mechanism of action has the potential to address both the causes and symptoms of dry eye disease in a new and distinct way, bringing relief to millions around the world.
Enhanced Ocular Delivery of TA-A001
Tetra Bio-Pharma and Altus Formulation Form New Company “TALLC” to Exploit TA-A001
© TALLC Inc. 2020