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Related Concept Videos

Ophthalmic Drug Delivery Systems01:23

Ophthalmic Drug Delivery Systems

Ophthalmic drug delivery faces major limitations due to poor absorption across the corneal membrane. This process is primarily driven by diffusion and is influenced by two main factors: the physicochemical properties of the drug and tear drainage. Most ophthalmic drugs, such as pilocarpine, epinephrine, atropine, and local anesthetics, are weak bases. They are typically formulated at an acidic pH to enhance chemical stability. However, this leads to high ionization, reducing their ability to...
Open Angle Glaucoma: Treatment01:27

Open Angle Glaucoma: Treatment

In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...
Glaucoma: Overview01:25

Glaucoma: Overview

Glaucoma is an eye condition characterized by increased intraocular pressure that damages the retina and optic nerve, leading to irreversible blindness if left untreated. The human eye has various components, including the cornea, iris, pupil, lens, and optic nerve. Aqueous humor is secreted by the epithelium of the ciliary body in the posterior chamber and flows through the trabecular meshwork and canal of Schlemm, maintaining normal intraocular pressure. The trabecular meshwork and the canal...
Drug Delivery: Miscellaneous Routes01:22

Drug Delivery: Miscellaneous Routes

Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection,  and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs through the...
Angle Closure Glaucoma: Treatment01:28

Angle Closure Glaucoma: Treatment

Angle-closure glaucoma, or closed-angle glaucoma, is an eye condition where the iris bulges out and blocks the iridocorneal angle, resulting in a buildup of aqueous humor and increased intraocular pressure. Immediate medical attention is necessary due to the sudden onset of symptoms. The treatment for angle-closure glaucoma includes short-term and long-term approaches. Short-term treatment involves using eye drops like pilocarpine to lower intraocular pressure by increasing aqueous humor...
Direct-Acting Cholinergic Agonists: Therapeutic Uses01:11

Direct-Acting Cholinergic Agonists: Therapeutic Uses

Direct-acting cholinergic agonists have many therapeutic uses in various medical fields. Choline esters, including acetylcholine, have limited clinical utility due to their non-selectivity and short duration of action. Still, acetylcholine and carbachol are applied topically during ophthalmologic surgery to induce miosis. Pilocarpine, a muscarinic and ganglionic stimulator, effectively treats open-angle glaucoma and alleviates xerostomia and dry mouth caused by radiotherapy or Sjögren syndrome.

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Ultrasound Cyclo Plasty in Eyes with Glaucoma
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Ultrasound Cyclo Plasty in Eyes with Glaucoma

Published on: January 26, 2018

Generic medications in ophthalmology.

Matt Zore1, Alon Harris, Leslie Abrams Tobe

  • 1Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA.

The British Journal of Ophthalmology
|November 13, 2012
PubMed
Summary
This summary is machine-generated.

This review examines generic drug approval in the US and Europe, focusing on ophthalmic medications. It explores regulatory pathways, safety, efficacy, and challenges in proving equivalence for topical eye treatments.

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Area of Science:

  • Pharmacology and Pharmaceutical Sciences
  • Ophthalmology
  • Regulatory Science

Background:

  • Generic drug programs increase medication accessibility and affordability.
  • Ophthalmic drugs present unique challenges for generic development and approval.
  • Regulatory frameworks in the US and Europe govern generic drug pathways.

Purpose of the Study:

  • To review the genericisation process for medications in the US and Europe.
  • To specifically analyze the landscape of generic ophthalmic drugs.
  • To explore regulatory guidelines, benefits, and drawbacks of generic drug adoption.

Main Methods:

  • Review of regulatory guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
  • Analysis of scientific literature comparing safety and efficacy of generic versus branded drugs.
  • Examination of studies addressing bioequivalence and therapeutic equivalence for topical ophthalmic formulations.

Main Results:

  • Genericisation offers significant cost savings but raises concerns about therapeutic equivalence.
  • Regulatory standards for generic drugs vary, particularly for complex formulations.
  • Demonstrating bioequivalence for topical ophthalmic drugs is a key challenge.

Conclusions:

  • Generic ophthalmic drugs can provide safe and effective alternatives.
  • Continued research and robust regulatory oversight are crucial for assuring equivalence.
  • Addressing challenges in bioequivalence testing is vital for patient access to quality generic eye medications.