Review of Myopia Management’s Post

This is such an important topic in pediatric patients. Highly insightful article. #myopia #myopiamanagement #myopiacontrol #optometry #optometrist #ophthalmology #ophthalmologist

Cecelia Koetting, OD FAAO DipABO, (University of Colorado Anschutz Medical Campus) and Mile Brujic, OD, (PREMIER VISION GROUP) discuss how 2 new pharmaceutical treatments have the potential to change the paradigm for treating #DryEyeDisease. #MeibomianGlandDysfunction (MGD) has a number of causes, but only a single result: #OcularSurface dryness. In fact, most instances of dry eye disease (DED) (approximately 85%) have some evaporative component, often instigated by a dysfunction of the meibomian glands.1 Research shows that patients with MGD usually (approximately 85% of the time) have a preponderance of #Demodex mites, which leave cylindrical waste materials along the lash follicle, clogging the meibomian gland and, ultimately leading to Demodex blepharitis.2,3 Read more: https://brnw.ch/21wJdVg #MeibomianGland #MGD #OcularSurfaceDryness #DryEye #DryEyeSymptoms #EyeHealth #EyeCare #DED #Optometry #Optometrist

#FDAapproved Botanix Pharmaceutical’s #newdrug sofpironium topical gel (Sofdra), on 6/20/2024, for the treatment of primary axillary hyperhidrosis. Brickell sold marketing and development rights for sofpironium to Botanix Pharmaceuticals in May 2022. The FDA rejected sofpironium and requested changes to patient use labeling in September 2023. Botanix resubmitted the NDA in January 2024. Approval of sofpironium was based on the results of the two Phase III, six-week, Cardigan trials in patients nine years of age and older with primary axillary hyperhidrosis. Results from the two studies were announced in October 2021. https://lnkd.in/gwEa9Hpw In the 350 patient, Phase III, Cardigan I trial, 49.3% of patients treated with sofpironium improved their Hyperhidrosis Disease Severity Measure-Axillary (HDSSM-Ax) score by at least 2 points and had a 129.5 mg decrease in their gravimetric sweat production compared to 29.4% and 99.3 mg with placebo. In the 351 patient, Cardigan II trial, 63.9% of patients treated with sofpironium improved their HDSSM-Ax score by at least 2 points and had a 145.9 mg decrease in their gravimetric sweat production compared to 47% and 131.7 mg with placebo. #prescriberight #pharmacists #physicians #nurses

Surgical Wound Debridement: Assessing Techniques and Outcomes in a Review Update A review of six studies on surgical wound debridement methods found mixed results. Autolytic debridement with dextranomer showed no superiority over other treatments. Enzymatic debridement with streptokinase/streptodornase had no advantage over saline dressings. Endoscopic surgical debridement showed potential benefits in reducing healing time. However, the overall evidence is uncertain due to biases and varied study quality. More robust trials are needed. Providers should consider the limitations and benefits of each method until more research is available. For more details please click the link! https://lnkd.in/dz6F3kHs #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

👁  A BREAKTHROUGH IN PRESBIOPIA TREATMENT! 👓 🔹 Mumbai-based Entod Pharmaceuticals' PresVu Ophthalmic solution has received DCGI approval. BRAND- PresVu by Entod Pharmaceuticals API- PILOCARPINE HYDROCHLORIDE Ophthalmic solution USP 1.25% w/v CLASS- Miotics, Cholinergic muscarinic agonist (Cholinomimetic Alkaloid) MOA- Cholinergic muscarinic agonist which activates muscarinic receptors located at smooth muscles (eg, iris sphincter muscle, ciliary muscle). It causes miosis, which constricts the pupil while preserving some pupillary reaction to light, improving near-visual acuity and depth of focus in presbyopes. INDICATION- Presbyopia is a common age-related visual disorder that affects people over the age of 40. It causes the eyes to gradually lose their ability to focus on nearby objects. AVAILABLENESS- According to Entod Pharmaceuticals CEO Nikhil Masurkar, the medication is expected to be available in pharmacies throughout India by October. 🖋 PRESCRIPTION DRUG 🖋 COST- A single vial of the eye drop, which is intended to last roughly a month, costs Rs 345. 🔸 'BETTER SUITED FOR INDIAN EYES' 🔸 Following FDA approval, a similar formulation was introduced in the United States under the brand name Vuity in 2022. Vuity is the only FDA-approved eye drop for treating age-related blurred vision. According to CEO Masurkar, PresVu contains adjuvants (components other than the API) that differ from those found in Vuity. This is because INDIAN IRISES ARE USUALLY MORE PIGMENTED. SIDE EFFECTS- Minor (redness was observed in 2% of subjects). CLINICAL TRIAL- Prior to clearance, PresVu was tested on 250 individuals at ten different sites across India. No patients were removed due to adverse effects. The CEO stated that comprehensive clinical data on this medicine will soon be published in a peer-reviewed journal, but is not currently publicly available. For more details, check out the full article: https://lnkd.in/dxS7YXAF #EntodPharmaceuticals #PresVuEyeDrops #ClinicalPharmacy #OphthalmologyCare #ThePrint #DCGIApproval #Mumbai #presbyopia #readingglasses #PatientCareFirst

Empower Pharma to Purchase Eugia Manufacturing Facility in New Jersey for Large Scale Expansion of Personalized Compounded Medicine NEWS PROVIDED BY Empower Pharmacy  05 Feb, 2024, 09:15 ET SHARE THIS ARTICLE      The East Windsor Site to Serve as Empower Pharma's Sterile Development and Bulk Manufacturing Business (503B) Outsourcing for Empower Pharmacy Allowing for Continued Exponential Growth HOUSTON, Feb. 5, 2024 /PRNewswire/ -- Empower Clinic Services New Jersey LLC DBA Empower Pharma today announced an agreement to purchase a facility in East Windsor, New Jersey from Eugia US Manufacturing LLC (wholly owned subsidiary of Aurobindo Pharma Ltd) and enter into a contract manufacturing relationship. In addition to the Houston facility, the site will serve as the second FDA-registered pharmaceutical manufacturing site of Empower Pharma for future contract development and sterile medication manufacturing business throughout the United States and internationally. The companies anticipate completing the transaction in the coming months, subject to the satisfaction of closing conditions. Upon closing, Empower Pharma will acquire the 170,000-square-foot site's operations and assets, which includes the facility's workforce. Empower Pharma is expected to use the facility, with its bulk manufacturing and automated fill-finish production capabilities, to expand its 503A, 503B, and contract development and manufacturing organization (CDMO) operations for the pharmaceutical industry. Empower Pharma will also be able to provide testing services in support of clinical trials. The facility will be capable of producing 50 million vials, or $1.5B in revenue per year, supporting a significant portion of the 503A and 503B industry. "We are confident that Empower will fully leverage the facility, its capabilities and its experienced workforce to play a vital role for patients in the future," said – Yugandhar Puvvala, Global CEO – Eugia Pharma Specialties Limited. "We believe this decision will allow us to more fully deliver on our mission of providing innovative medicines for patients around the world." "This state-of-the-art facility will enable us to bring the highest levels of capacity and supply chain resilience to both our 503A and 503B business lines, while supporting our new partnership with Eugia Pharma and the growing demand of outsourced medicine for thousands of pharmacies throughout the country," said Shaun Noorian, Chief Executive Officer and Founder of Empower. About the East Windsor, New Jersey facility The East Windsor, New Jersey site is a state-of-the-art manufacturing facility opened in 2023 with commercial-scale production capacity including clean rooms and supporting utilities for the injectable manufacturing plant. Media Contact: Media@empowerpharmacy.com SOURCE Empower Pharmacy

Interested in learning more about topical hemostatic agents used in various clinical care settings to control bleeding? Click the link below to learn more. PfizerMedical Portal contains numerous educational resources on Pfizer Surgical topical hemostats #Hemostats #Surgery #Bleeding

Device Receives Breakthrough Status: FDA Grants CereVasc’s eShunt System a Key Milestone in Hydrocephalus Treatment CereVasc's eShunt System, designed as a less invasive treatment for normal pressure hydrocephalus, has received breakthrough device designation from the FDA, which will expedite its review and potential market introduction. The system aims to reduce hospital stays, patient discomfort, and complications by offering an alternative to traditional ventriculoperitoneal shunt surgeries. The FDA also granted investigational device exemption approval for the STRIDE pivotal study, set to begin in the second half of 2024, which will compare the safety and efficacy of the eShunt System against the current standard of care. This innovation could significantly improve treatment options for over 700,000 individuals in the U.S. affected by NPH, potentially transforming neurosurgical care. For more details please click the link! https://lnkd.in/dt2_vHSY #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Exploring the Efficacy of Various Debridement Methods in Surgical Wound Healing A review of six studies on surgical wound debridement techniques found mixed results. Dextranomer beads or paste were not superior to other treatments, and enzymatic debridement had no significant advantage over saline dressings. Endoscopic surgical debridement may reduce healing time compared to open surgical methods. However, the overall evidence is uncertain due to bias and methodological limitations in the studies. More research is needed to establish definitive conclusions and improve patient outcomes in surgical wound management. For more details please click the link! https://lnkd.in/dXeNkt8m #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Innovative dECM Scaffolds in Regenerative Endodontic Procedures: A Systematic Review A recent systematic review examined the use of decellularized extracellular matrix (dECM) scaffolds in regenerative endodontic procedures (REPs) for tissue regeneration. The review assessed histological outcomes and factors impacting efficacy. The study used comprehensive search methods and included 17 relevant articles out of 387. The findings suggested that dECM scaffolds have the potential to promote tissue regeneration, but variations in methodology and delivery methods led to a high risk of bias. The study calls for standardization and improved protocols in future research to ensure reliable results. The review also highlights the potential of dECM scaffolds in dentin-pulp regeneration, but emphasizes the need for cautious interpretation and further rigorous studies. For more details please click the link! https://lnkd.in/d4YyuDiW #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical