Pfizer has announced that, as of May 2021, it will stop distributing Phospholine Iodide, one of the only eye drops that is effective in treating aphakic glaucoma.* 

What is aphakic glaucoma?

Aphakic glaucoma is a rare condition that can develop in eyes that don’t have a natural lens. While some people are born without a lens, most cases are the result of the natural lens being removed during cataract surgery and not being replaced with a synthetic one. As with other types of glaucoma, the aphakic form causes your internal eye pressure, known as intraocular pressure (IOP), to increase. Without timely and effective treatment, the condition leads to progressive vision loss and blindness. 

Phospholine Iodide, a cholinesterase inhibitor that works by shrinking your pupil and decreasing the amount of fluid in your eye, is seemingly the only effective medication for treating aphakic glaucoma, and Pfizer is the only distributor of the drug.

Why is Pfizer taking the drug off the market?

Outside companies supply many of the medication’s components, including:

• active and inactive ingredients,
• sterilized packaging materials, 
• technologies, and 
• final formulation. 

The toxic active ingredient in the drops also requires special handling and transportation. A Pfizer spokesperson explained that the company is discontinuing the drops due to “a complex chain of external partners” that is “increasingly unstable.” This instability has led to prior drug shortages.

Pfizer estimates that there are only about 100 patients using the drops in the U.S., so the market is small and fairly static. From a financial perspective, discontinuing the product makes sense, although doing so runs the risk of bad publicity and public outcry. 

“We understand that some patients, caregivers, and ophthalmology scientific organizations are disappointed about Pfizer’s decision to discontinue Phospholine Iodide,” said a Pfizer spokesperson. “We did not come to this decision lightly.”

What are the alternatives?

The decision represents an ongoing predicament facing drug makers, healthcare providers, and patients. Aphakic glaucoma patient Carol Vaghar, 62, and several other patients have tried to convince Pfizer to reverse its decision, which was announced in October 2020, but so far, their efforts have been unsuccessful. 

The group has also attempted to locate another company who would be willing to manufacture the drops, but such an undertaking would require regulatory approval, which is a time-consuming process. It may not even be feasible, given the manufacturing challenges, for another company to step in.

“Unfortunately, I don’t think anybody is going to produce the drug,” said Alan Robin, executive vice president of the American Glaucoma Society, and an associate professor of ophthalmology and international health at Johns Hopkins University. “There’s only a select group of people for whom this works.”

“If this goes off the market, we’ll probably have to do surgery for some patients to control their pressure,” said Boston ophthalmologist David Walton. Walton treats between 40 and 50 patients with aphakic glaucoma, including children. “They’re scared and anxious and desperate,” he added. “It’s a very intense concern.” 

*Silverman, E. (2021, Apr. 22). ‘There are no alternatives’: As Pfizer discontinues an old glaucoma drug, a small group of patients struggles to cope. STAT News. 

https://www.statnews.com/pharmalot/2021/04/22/pfizer-eye-glaucoma-emergent-discontinue/ 

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