Allergan announced eye drops to treat age-related presbyopia have shown effectiveness in two phase III trials and the clinical trial data is ready to be submitted to the FDA for drug approval in early 2021.
NOTE: This is news about an ongoing trial. This drop for presbyopia is not FDA approved, but is in the process of potential approval.
What is Presbyopia?
Presbyopia develops in everyone around the age of 40-45. As we age, we lose the ability to focus at near, but with bifocals or “readers,” the problem is alleviated. Research in many areas is ongoing to “cure” presbyopia. Examples include monofocal contact lenses, laser vision correction, intraocular implants (IOLs), etc.
Phase III trials assess the side effects of new drugs and compare a new drug to the standard care. Participants in a phase III study are watched closely and the study is stopped early if the side effects of the new drug are too severe or if one group has much better results.
The two phase III clinical trials enrolled a total of 750 patients who were randomly selected for one of two groups—one receiving the 1.25% pilocarpine ophthalmic solution and the other group receiving a placebo eye drop.
Results of Testing
The eye drops tested, called AGN-190584 for the clinical trial, were a 1.25% pilocarpine ophthalmic solution. The trial showed a statistically significant number of trial participants gained 3 lines or more lines on a reading chart in a low-light situation without a loss of distance vision. The most common treatment side effect, occurring in about 3% of the study participants who received AGN-190584, were headache, conjunctival hyperemia, blurred vision, and eye pain.
AGN-190584 is an optimized formulation of pilocarpine, a cholinergic muscarinic receptor agonist. A muscarinic agonist is an agent that activates the activity of the muscarinic acetylcholine receptor. In other words, pilocarpine stimulates the iris sphincter and ciliary muscles regulating their tone and ability to contract and accommodate near vision. Pilocarpine is also used in glaucoma eye drop treatments.