WASHINGTON, September 14, 2022 /PRNewswire/ — The U.S. Patent Office has granted 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 effective excipients that are comfortable for the eyes. These formulations have been used in over one million cataract surgeries and several million topical eye applications, such as after LASIK surgery.
The primary combination is an injectable formulation that significantly improves postoperative compliance, alleviates eye irritation by avoiding eye drop toxicity, and eliminates the need for topical medications in 98% of patients recovering from very severe cataract surgery. current. Topical formulations using the patented intellectual property (IP) of NDS-ECNW consist of different concentrations of topical steroids that are well suited to suppress ocular inflammation and treat the risk of bacterial infection with effective and convenient dosing (even daily and twice a day).
“Cataract and LASIK surgeries themselves are common and frequently performed procedures, but the complications associated with recovery can be vexing and even catastrophic,” says Dr. Liegner, CEO of innovative company NDS-ECNW. “In particular, as many cataract patients are elderly, physical limitations (eg, reduced strength and range of motion, tremors, impaired hand-eye coordination) can be challenging and make patient compliance problematic. Eye drop phobia and the significantly higher cost of eye medications, combined with more restricted formularies, also discourage the proper use of postoperative eye drops. cataract, removes these burdensome burdens on the patient; and the formulation does not require toxic or uncomfortable preservatives to stabilize the drug combination.”
With the frequency of cataract surgery and LASIK procedures increasing globally, the global market potential for topical injectable and post-surgical formulations is estimated to exceed $60 million annually. Eye care prescribers are keenly interested in preservative-free eye drops with varying concentrations of steroids requiring less dosing and better compliance. The IP protection now secured by NDS-ECNW extends to 33 countries (including all Europe, Australia, New Zealand, Israel, Canadaand Mexico). The company is seeking domestic and international manufacturing partners as it prepares for the product launch.
“The challenges associated with combination ocular medications are that often effective surfactants and suspending agents (called excipients) are incompatible as solubility agents and are often uncomfortable for patients,” says Dr. Liegner, whose eye drug developments with Mr. Karolchyk (NDS) resulted in the products originally marketed by Harrow Health and its subsidiary ImprimisRx. Following a 2021 jury verdict and settlement against Harrow Health, the now-patented combination products contain the unique Poloxamer excipient, which NDS-ECNW designed to be both new and more comfortable for the patient than the other combination products available. “The patent office has recognized that our advanced engineering technology, which applies Poloxamer 407 as an excipient with proprietary manufacturing steps, results in a formula that is both effective and highly stable without complicating eye drops with preservatives and extraneous ingredients. .”
The active ingredients in the injectable product are triamcinolone acetonide, a potent steroid, combined with moxifloxacin, a fourth-generation broad-spectrum fluoroquinolone antibiotic that provides a single dose of inflammatory suppression and infection prophylaxis associated with surgery for the cataract. An injection at the end of the procedure avoids the need for eye drops in 98% of patients, while reducing infections by a factor of 125 compared to eye drops alone. The legacy formulation has been used in over one million cataract surgeries (UNITED STATES) without incident and was received favorably by patients otherwise unfavorable to the use of eye drops. The proprietary manufacturing process results in controlled particles of steroids, 99% of which are smaller than a red blood cell, creating better eye penetration than other formulations currently on the market.
The same IP formulation techniques can also be used to produce topical eye drops for LASIK, ocular surface diseases, and postoperative eye care at the discretion of the clinician. When combined with several different antibiotics and the use of eye-friendly steroids of different potencies such as prednisolone acetate, difluprednate, and triamcinolone, topical therapies given once or twice daily are both more convenient and effective. than other commercially available products made with non-patented formulations. Additionally, the addition of the NSAID drug nepafenac further enhances topical therapy when clinically appropriate.