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 remedies, using safe and superior-performing excipients that are comfortable in the eye.

According to a news release, these formulations have been used in over a million cataract surgeries and many millions of topical eye applications such as after LASIK surgery.

The primary combination is an injectable formula that significantly improves postoperative compliance, eases eye irritation by avoiding eye drop toxicity, plus eliminates the need with regard to topical medications in 98% of patients recovering from the particular very commonly performed cataract surgery procedure.

The topical ointment formulations using NDS-ECNW’s patented intellectual property (IP) consists of various strengths of topical cream steroids which are well suited to suppressing ocular inflammation and treating bacterial infection risk with effective and convenient (even daily and twice daily) dosing.

Liegner, CEO of the NDS-ECNW company, said within the news release that cataract and LASIK surgeries themselves are common plus frequently performed procedures, but the complications around recovery can be vexing and even catastrophic.

“In particular, with many cataract individuals 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, ” he said. “Eyedrop phobia plus the considerably higher cost of topical eye medicines, coupled with more restricted formularies, also deter proper postoperative eyedrop use. The legacy injectable product, delivered at the time of cataract surgery, removes these burdensome demands on the patient; and the formulation does not require toxic or uncomfortable preservatives to stabilize the drug combination. ”

Moreover, the information release also noted that will with the frequency of cataract surgery and LASIK procedures growing globally, the worldwide market potential for the particular injectable plus post-surgical topical ointment formulations is estimated in order to exceed $60M annually. Eye care prescribers are keenly interested in preservative free eye falls with variable steroid advantages requiring less dosing and 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 plus international manufacturing partners as it prepares for a launch from the product.

“The challenges associated with combination vision medications is that often the effective surfactants and suspending agents (known as excipients) are incompatible as solubility agents and are often uncomfortable to patients, ” said Liegner, whose attention medication developments with Karolchyk led in order to the products that were originally marketed simply by Harrow Health and their subsidiary ImprimisRx.

As a result of a 2021 jury verdict and settlement against Harrow Health, the particular now trademarked combination products contain the unique excipient Poloxamer, which NDS-ECNW designed to become both novel and a lot more comfortable regarding the individual than other available mixture products. “The Patent office recognized that our advanced engineering technology, which usually applies Poloxamer 407 as an excipient with proprietary production steps, results in both an effective and highly stable formula without complicating the eyedrop with preservatives and extraneous ingredients. inch

The active ingredients in the particular injectable product are Triamcinolone acetonide, the potent steroid, combined with Moxifloxacin, a fourth-generation broad spectrum fluoroquinolone antibiotic that provides one dose inflammatory suppression and anti-infective prophylaxis related to cataract surgery.

One injection in the conclusion of the process obviates the need intended for eye drops in 98% of sufferers, while reducing infections by a factor of 125x over eyedrops alone. The legacy formulation has been utilized in more than a million cataract surgeries (USA) without incident and has already been received favorably by patients otherwise adverse to making use of eye falls. The proprietary manufacturing process leads to managed particulates associated with steroids, 99% of which are smaller than the red blood cell, creating better ocular penetration than other currently marketed formulations.

The same IP formulation techniques can also be used to produce topical cream eye drops for LASER EYE SURGERY, ocular surface disease plus postoperative eyesight care at the discretion from the clinician. Combined with several different antibiotics and using various strength eye-friendly steroids like prednisolone acetate, difluprednate, plus triamcinolone, topical therapies along with once or twice a day dosing are both more hassle-free and more efficient than some other commercially available products produced with non-patented formulations. Also, the addition of the particular NSAID nepafenac drug further fortifies the topical therapy when clinically appropriate.

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