When considering 962 million people
globally were aged 65 years or over in 2017, the number of people in
this age bracket is expected to nearly double by 2050 - a total of 1.6
5% of people aged 65 or over develop glaucoma, a group of optic
neuropathies resulting from damage of the optic nerve caused by
intraocular pressure, which is the second leading cause of irreversible
blindness. With a predicted 80 million people affected by glaucoma by
2020, it will be one of the most prevalent ocular diseases.
Drugs are usually the first line of treatment for primary
open-angle glaucoma (POAG), the most common type of glaucoma. Alpha
agonists like Brimonidine decrease the production of aqueous humour and
increase uveoscleral outflow. Beta blockers (i.a. Timolol) and Carbonic
anhydrase inhibitors (i.a. Dorzolamide, Brinzolamide) decrease the
aqueous humour through the ciliary body, whereas Miotics (i.a.
Pilocarpine) and Prostaglandin analogues (i.a. Latanoprost, Bimatoprost,
Travoprost) improve the drainage. Rho khinase inhibitors (i.a.
Netarsudil) are a new class of glaucoma drugs, first launched in 2018.
Such Rho khinase inhibitor eye drops reduce the elevated intraocular
pressure (IOP) by suppressing the rho khinase enzymes which produce the
Prostaglandine analogues are the standard first line treatment to
decrease IOP due to their advantage of greater efficacy. Manufacturers
have launched combination products combining the Prostaglandine
analogues with a beta-blocker and these drugs are predominantly being
used once or twice a day.
Single-use vials (often produced in the Blow-Fill-Seal
technology) do not protect the contents from contamination after they
are opened, meaning the patient needs to throw them away after the
administration of just one dose. In this case, the more cost-effective
option would be to use multidose containers, which enable the frequent
use of the product to deliver the required dose daily.
The industry has been challenged to design multidose eye drops
which satisfy all the regulatory guidelines set out by the authorities.
EMA recommends sterile eye drops to be preservative-free, as it is known
that preserving agents cause side-effects like irritation of the ocular
surface, and also to dispense a defined metered dose with each drop.
Preservative-free multidose systems either have an airless container like the COMOD®-system
or require a special sinter-filter with antimicrobial properties to
compensate the vacuum formed inside the container after the drop is
dispensed, as well as with a valve that forms a microbiologically tight
seal (e.g. the 3K®-technology in Aero Pump’s Ophthalmic Multidose
Due to the expiry of patents relating to anti-glaucoma products
in the past few years, many generic products with a Prostaglandine
analogue are under development. Based on the latest guidelines, those
manufacturers are often looking to launch their products in
preservative-free multidose containers (see below reference products).
The launch of novel anti-glaucoma drugs with additional
neuroprotective properties that avoid loss of retinal ganglion cells are
set to become a major breakthrough in glaucoma treatment. Currently,
numerous clinical trials are taking place combining formulations with
the benefits of using just one bottle for several medications.
For glaucoma patients and ophthalmologists it is an exciting time
as these new medications promise improved characterizations by directly
targeting the trabecular meshwork.
About Aero Pump’s preservative-free Ophthalmic Multidose System
Aero Pump GmbH, together with its partner URSATEC Verpackung
GmbH, have developed a preservative-free Multidose System with the so
called 3K®-technology. Special germ-reducing components
inside the 3K®-system ensure the microbiological safety of the device.
This pump system is available for use with plastic or glass containers
and in terms of reducing container interaction with the product, this is
a particular advantage.
The 3K®-system delivers an accurate dose over the
whole life cycle of the product, with one measured drop per actuation.
Conventional squeeze devices on the other hand are known to have an
imprecise dose accuracy; some can even create an extremely uncomfortable
jet when squeezed.
The actuation force of Aero Pump’s Ophthalmic Multidose System is
stable, independent of the residual liquid inside the container. This
fact is especially noticeable for older patients where it can be very
difficult to eject the last few drops of the liquid, which can often
lead to an increased residual volume when squeeze devices are used.
Alongside the development of the Ophthalmic Multidose Devices,
Aero Pump has developed various customer-friendly actuation aids that
enable a convenient application of the drop into the eye of the patient.