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ophthalmic compounding

The Current Landscape of Ophthalmic Compounding

An estimated 16 million adults in the United States (approximately 6.8 percent of the population) are diagnosed with dry eye disease (DED). Interestingly, the prevalence is higher among women than men and DED often increases with age, with a higher risk of diagnosis rate among those aged 45–54 years.

The Benefits of Ophthalmic Compounding

Due to commercially available medications not always being accessible to medical professionals to effectively treat DED patients, many prescribers look to compounding pharmacies to ensure that patients receive the best possible care. Compounded drugs allow medical professionals to personalize ophthalmic treatments. These medications can be more efficacious when patients have not responded well to over-the-counter (OTC) and commercially available products.

There are myriad reasons why brand name and generic drug options are not the optimal treatment option. To start, the compounding pharmacist is able to formulate the physical, chemical, and microbiological aspects of the medication according to the prescriber’s requirements.

Patients with infectious ulcers, for example, are pertinent beneficiaries. Infectious keratitis is a significant cause of ocular morbidity in the US, representing 3 of every 1,000 patients seen by an ophthalmologist. When patients do not respond to broad-spectrum antibiotics, this necessitates urgent diagnostic and microbiology intervention to adapt the antibiotic coverage according to the severity of the corneal ulcers. In such cases, compounding pharmacies are an essential source of otherwise unavailable medications.

Such personalization of treatment can improve efficacy, adherence, convenience, and affordability for your patients. However, ophthalmic compounding must be supported by highly specialized equipment and conducted within a sterile environment. These guidelines are mandated by USP (United States Pharmacopeia) for the preparation of all eye medications, which are a highly-specialized area of expertise.

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VLS Pharmacy and New Drug Loft: Compounding to Your Requirements

OTC and commercially available prescriptions may not suit your patients’ ophthalmic conditions. The eye is an extremely sensitive organ, and many individuals display allergic responses to the preservatives found in common medications. VLS Pharmacy’s ophthalmic compounding allows you to provide such medication preservative-free.

You may struggle to support patients when an FDA-approved product is on backorder or – even worse – discontinued. Chances are, we can compound the medication you need during times of shortages. In fact, many medical professionals reached out to us when cycloplegic agents and dorzolamide were unavailable

By providing individualized treatment, your patient’s recovery can be improved thanks to the personalized regimens, strengths, and dosages made possible with ophthalmic compounding. VLS works with you to ensure that your customized prescriptions are compounded and shipped in a timely manner. At VLS Pharmacy and New Drug Loft, we are experienced in the personalized treatment of:

  • Cataracts
  • Conjunctivitis (pink eye)
  • Chronic dry eye
  • Fungal eye infections
  • Glaucoma
  • Macular degeneration

Additionally, we are able to assist with:

  • Dilators and Topical Anesthetics
  • Diagnosis 
  • Antibiotics

As a 503A pharmacy, we are positioned to supply both adult and pediatric patients with ophthalmic compounds – whether you support your patients as outpatients or in a hospital or surgical setting.

Off-Label Ophthalmic Treatments: Diabetic DED

One of the most promising, recent applications of off-label ophthalmic compounds that our clients ask us to provide is that of low dose naltrexone (LDN) to treat corneal surface abnormalities associated with diabetes. Diabetes, which impacts nearly 10 percent of our country’s adult population, leads to issues with DED, keratopathy, or retinopathy in more than half of cases.

Typically, diabetic patients with DED turn to OTC medications or receive a prescription from their medical team for specialized eye drops, which are expensive and do not directly address the diabetic implications.

Evidence is building that opioid growth factor (OGF) – integral to the OGF-OGFr axis – plays a key role in the regulation of homeostasis in both corneal epithelialization and tear secretion. In diabetic patients, [Met5]-enkephalin, or OGF appears to be dysregulated, resulting in decreased cell replication and increased corneal surface sensitivity. OGF appears to play a role in cell proliferation by delaying the G0/G1 phase of the cell cycle. An agent capable of blocking the opioid growth factor (OGF)-opioid growth factor receptor (OGFr) axis encourages increased cell proliferation.

Early research suggests that topical LDN can help regulate the OGF-OGFr axis to restore corneal sensitivity and regulate the rates of corneal re-epithelialization, ultimately resolving secondary diabetic symptoms of DED.

Such LDN treatment requires dosages that are substantially lower than those approved by the FDA for naltrexone therapies. The most common ophthalmic naltrexone dose is a 0.2 percent formulation prescribed to treat DED.

Off-label applications of LDN include:

  • Autoimmune retinopathy
  • Autoimmune uveitis
  • Blau syndrome
  • Cogan’s syndrome
  • Devic’s disease (neuromyelitis optica)
  • Ligneous conjunctivitis
  • Miller-Fisher syndrome
  • Mooren’s ulcer
  • Neuromyelitis optica
  • Ocular cicatricial pemphigoid
  • Optic neuritis
  • Opsoclonus myoclonus syndrome
  • Pars planitis (peripheral uveitis)
  • Scleritis
  • Susac’s syndrome
  • Sympathetic ophthalmia (SO)
  • Thyroid eye disease (TED)
  • Tolosa-Hunt syndrome (THS)
  • Uveitis
  • Vogt-Koyanagi-Harada Disease

VLS Pharmacy and New Drug Loft

As a 503A pharmacy specializing in sterile and non-sterile compounding for nearly three decades, we support you in providing your patients with safe, personalized, and efficacious pharmaceutical therapies. By working with us, you ensure that your team can offer patients effective, sustainable care.

Our licensed compounding pharmacists are skilled in advanced aseptic techniques, and all compounds are independently tested by third-party facilities. Our multi-state licensure and efficient turnaround times allow you to predictably implement personalized patient protocols. VLS Pharmacy and New Drug Loft enforces rigorous testing measures to guarantee the safety, stability, purity, sterility, and quality of each formulation from preparation to administration. Additionally, our pharmacy network meets USP <795> non-sterile standards and USP <797> sterile compounding guidelines. VLS Pharmacy and New Drug Loft are proud to host one of the first pharmaceutical labs built to USP <800> standards for handling hazardous drugs.

All VLS Pharmacy and New Drug Loft medications are submitted for third-party potency and stability testing, and we complete high-sensitivity rapid endotoxin detection on-site, resulting in shorter delivery times to your patient without compromising the product. VLS Pharmacy and New Drug Loft sources all of our active ingredients from PCCA, which adds an additional level of preformulation testing, as all PCCA ingredients undergo 14 high-level checks and reviews in order to pass inspection.

 

Reach out to our team to learn about best practices and to partner with our experts on custom compounded medications for your patients.

All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.

 

 


 

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