WASHINGTON , Sept. 14, 2022 /PRNewswire/ — The US Patent Office has issued Patent 11, 439, 590 to Scott Karolchyk (NDS) and Jeffrey Liegner MD (ECNW) for the legacy formulation of ophthalmic formulations containing corticosteroids combined with various antibiotics, using safe and superior-performing excipients that are comfortable in the eye. These formulations have been used in over a million cataract surgeries and many millions of topical eye applications such as after LASER EYE SURGERY surgery.
The primary combination is an injectable formulation that significantly improves postoperative compliance, eases eye irritation by avoiding eye drop toxicity, plus eliminates the particular need with regard to topical medications in 98% of patients recovering from the very commonly performed cataract surgery procedure. The topical formulations using NDS-ECNW’s patented intellectual property (IP) consists of various strengths of topical ointment steroids which are well suited to suppressing ocular inflammation and treating bacterial infection risk with effective and convenient (even daily and twice daily) dosing.
“Cataract and LASIK surgeries themselves are common and frequently performed procedures, but the complications around recovery can be vexing plus even catastrophic, ” says Dr. Liegner, CEO of the innovative NDS-ECNW company. “In particular, with many cataract patients being elderly, physical limitations (e. g., reduced strength and range of motion, tremor, impaired eye-hand coordination), can be challenging and makes patient compliance problematic. Eyedrop phobia and the considerably higher cost associated with topical vision medications, combined with more restricted formularies, also deter proper postoperative eyedrop use. The heritage injectable product, delivered at the time of cataract surgery, removes these burdensome demands on the particular patient; plus the formula does not require toxic or uncomfortable preservatives to stabilize the drug combination. ”
With the frequency of cataract surgery and LASIK procedures growing globally, the worldwide market potential for the injectable and post-surgical topical formulations is estimated to exceed $60M annually. Eye care prescribers are keenly interested in preservative free eye drops with variable steroid advantages requiring less dosing plus improved compliance. The IP protection now secured by NDS-ECNW extends to 33 countries (including all of Europe , Australia , New Zealand , Israel , Canada , and Mexico ). The company is seeking domestic and international manufacturing partners as it prepares for a launch from the item.
“The challenges associated with mixture eye medications is that often the efficient surfactants plus suspending agents (known as excipients) are usually incompatible as solubility brokers and are often unpleasant to individuals, ” says Dr . Liegner, whose attention medication developments with Mr. Karolchyk (NDS) led to the particular products that were originally marketed by Harrow Health and their subsidiary ImprimisRx. As a result of the 2021 jury verdict plus settlement against Harrow Health, the right now patented combination products contain the unique excipient Poloxamer, which NDS-ECNW designed to be both novel and more comfortable for the patient than other available combination products. “The Patent office recognized that our advanced engineering technology, which usually applies Poloxamer 407 while an excipient with proprietary manufacturing steps, results in both an effective and highly stable formula without complicating the eyedrop along with preservatives plus extraneous ingredients. ”
The active components in the injectable product are usually Triamcinolone acetonide, a potent steroid, mixed with Moxifloxacin, a fourth-generation broad spectrum fluoroquinolone antibiotic that provides one dose inflammatory suppression and anti-infective prophylaxis associated with cataract surgery. One injection at the conclusion of the particular procedure obviates the need for eyesight drops within 98% of patients, while reducing infections by a factor of 125x over eyedrops alone. The particular legacy ingredients has been used in more than a million cataract surgeries ( USA ) without incident and has been received favorably simply by patients otherwise adverse in order to using eye drops. The proprietary manufacturing process results in managed particulates associated with steroids, 99% of which are smaller than a red blood cell, creating better ocular penetration than other currently promoted formulations.
The same IP formulation techniques can also be used to produce topical cream eye falls for LASIK EYE SURGERY, ocular surface disease and postoperative eyes care at the discretion of the clinician. Combined with several different antibiotics plus using various strength eye-friendly steroids like prednisolone acetate, difluprednate, and triamcinolone, relevant therapies with once or twice a day dosing are both more hassle-free and much more effective than some other commercially obtainable products produced with non-patented formulations. Also, the addition of the NSAID nepafenac drug further fortifies the particular topical therapy when clinically appropriate.