Ophthalmic APIs Explained

Ophthalmic APIs are a specialised category of Active Pharmaceutical Ingredients (APIs) that target various conditions and diseases related to the eyes.

The human eye is a sensitive and critical organ, so Ophthalmic APIs are small-volume products with high purity and stringent microbiology requirements because they are often applied directly to the eye.

Ophthalmic APIs are designed to address a range of ocular conditions, including but not limited to glaucoma, presbyopia, eye infections, dry-eye disease and macular degeneration.

The Ophthalmic API market is growing fast, says C2 Pharma’s CEO Andrew Badrot.

“With an ageing population, heightened awareness of eye disorders, and advancements in eye care technology, the entire population has faced an increase in shortages and limited access to reliable medications” he says.

“In 2022 the Ophthalmology Drugs Market was valued at USD $33.4 Billion and this is expected to reach USD $61.5 billion by 2032 with the highest growth in the treatment of Aged Macular Degeneration and of Dry Eye Disease (DED).” says James Lawler, General Manager, C2 Pharma. 

“2023 was dubbed ‘The Year of the Dry Eye” due to the increased prevalence of Dry Eye Disease in humans” James adds.

 

Types of Ophthalmic APIs

There are several types of APIs in this category, each targeting different conditions or providing different therapeutic effects. 

Key types of Ophthalmic APIs include:

• Atropine: Used to dilate the pupils for certain eye exams.
• Pilocarpine: Used to treat glaucoma by reducing pressure inside the eye.
• Cyclopentolate: Used to temporarily paralyze the muscles that allow the eye to focus.
• Brimonidine: Used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
• Tropicamide: Used to dilate the pupil for eye examinations.
• Bimatoprost and Latanoprost: Used to treat certain types of glaucoma and other causes of high pressure inside the eye.
• Oxybuprocaine: A local anaesthetic used in the eye to prevent pain during procedures.
• Naphazoline: A decongestant used to relieve redness, puffiness, and itchy/watering eyes due to colds, allergies or eye irritations.

The typical dosage forms for these APIs are eye drops, topical applications, ointments, and injectables.

The importance of GMP

It is essential that Ophthalmic APIs are manufactured, packaged, and stored under current Good Manufacturing Practices (cGMP). This ensures that they are produced and controlled according to quality and safety standards.

The quality of a product can be defined by several factors, including its ability to meet specifications, that it is fit for intended use, and that it can satisfy customer requirements.

It can be easily proven that the stability and efficacy of medicinal products can be adversely affected when they are stored incorrectly; therefore, Ophthalmic APIs must be manufactured, packaged, and stored under GMP throughout the entire distribution chain to ensure the safety and effectiveness of the final product.

The risks of using Ophthalmic APIs that have not been produced and controlled by GMP requirements is significant, and can lead to untreated eye conditions, infections, and even damage to the patient’s eye.

In recent years, for example, with the EzriCare and Delsam artificial lubricant eye drops case that was recalled in February 2023, the CDC reported 81 infections in 8 states. Of those cases, 14 patients reported vision loss, 4 had their eyeballs removed, and 4 patients died.

How C2 Pharma are pioneering the future of Ophthalmic APIs

C2 Pharma, a global leader in the realm of Ophthalmic Active Pharmaceutical Ingredients (APIs) has carved a niche for itself in the pharmaceutical industry. Their APIs, manufactured from both synthetic and natural origins, have set new benchmarks in the ophthalmic space.

Established in 2014, C2 Pharma has spent a decade of extreme focus, dedication, and hard work to make their mark. Upholding a passion for excellence, they continually strive to redefine industry standards and push the boundaries of innovation in eye care solutions.

“At C2 Pharma, we strive to provide the best cost-to-quality solutions, ensuring consistent delivery of high-quality active pharmaceutical ingredients and services to meet the heightened demand globally.” says Andrew Badrot.

This commitment is reflected in their unique manufacturing model, where they implement stringent quality oversight of their contract manufacturers. They take pride in providing excellent customer service to their global clientele, which includes over 200 customers internationally. Their reach extends to almost every ophthalmic pharmaceutical producer, from Japan to Argentina.

C2 Pharma is is a key sponsor of the “Partnership for a Better World” program. This initiative ensures sustainable, traceable, and fair-trade harvesting and sourcing of phytochemicals and botanicals used for pharmaceutical APIs such as Pilocarpine. The program sustains more than 1,000 families and contributes significantly to preserving Brazilian biodiversity.

For more information or enquiries, C2 Pharma can be contacted at info@c2pharma.com.