Ophthalmic Drugs – Ocular Drug Delivery Overview

What is Ocular Drug Delivery?

Ocular drug delivery systems are designed to be applied onto the external surface of the eye, administered inside or adjacent to the eye, or used in conjunction with an ophthalmic device. These ocular delivery methods are used to combat against any ailment or disorder involving vision.

What are Different Types of Ocular Drug Delivery Systems?

There are several different types of ophthalmic drug delivery systems including, but not limited to, liquids (such as eyedrops and lotions), ointments, aqueous gels, and suspensions. New advances in ocular drug delivery have required the use of medical devices as a vessel to administer ophthalmic drugs. Some devices that have seen success in ophthalmology are punctum plugs, ocular implants, drug-eluting contact lenses, iontophoresis (mild electric charges to deliver through ocular barriers) devices, electromechanical tear stimulators, and others. 

New Regulatory Guidance with Ocular Drug Delivery Systems

In previous years, products such as eye shields, eye droppers, and other ophthalmic dispensers were regulated as drugs when they were packaged with an ophthalmic drug. In April of 2021, it was determined by the U.S. Court of Appeals for the District of Columbia Circuit that “…devices must be regulated as devices and drugs- if they do not satisfy the device definition- must be regulated as drugs.” The FDA determined that this statement indicated ophthalmic dispensers and devices packaged with ophthalmic drugs can no longer be regulated as “drugs” and must be regulated as “devices.”

In March 2022, the FDA released new guidelines to manage products such as those listed above. The new regulations require products that fall into the “device” category to be regulated separately from the drug they are packaged with. These are considered “combination devices” which have been monitored and categorized by the FDA since 2002 to ensure proper regulation of each product within the combination. The ophthalmic device components now need to comply with either the full 21CFR §820 device quality system regulations or, more typically, a streamlined quality system regulation under 21 CFR §4.4(b)(1) system. In either case, device design controls under 21 CFR §820.30 will apply. This new guidance can significantly impact the ophthalmic drugs market, requiring pharmaceutical companies to understand the depths of combination devices.

Hear From Our Regulatory Policy Expert

“This aspect of the device quality system regulation is often least familiar to our pharmaceutical clients that do not typically manufacture drug combination devices. We can assist clients with the design control requirements of the device quality system or any other novel elements. Additionally, we can assist with the development of appropriate documentation and/or testing to meet the new requirements.”

-Jim Fentress, Director of R&D and Regulatory Policy

Gilero’s Expertise with Ophthalmic Devices

Gilero has worked with many medical device companies to develop market ready ophthalmic devices. Preservative free eye drop applicators, ophthalmic syringes, implant injectors, and electromechanical tear stimulators are some examples of devices we have produced. We achieve high quality results with our established and experienced engineering team who work to ensure your ophthalmic medical device is properly designed and developed to your specifications. Gilero also offers human factors engineering and validation studies, prototyping, clinical builds, and contract manufacturing to provide a comprehensive solution for your ophthalmic device needs. 

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