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Next month, an eye drop that Carol Vaghar has taken for the past few years to manage a rare form of glaucoma will no longer be available, leaving her little choice but to consider potentially risky surgery to maintain the pressure in her eyes.

The 62-year-old real estate agent developed cataracts in both eyes many years ago and after surgery, developed aphakic glaucoma, which causes intraocular pressure to rise dramatically. Vaghar tried various medications, but only one — a decades-old eye drop called Phospholine Iodide — has been effective. But Pfizer (PFE), which is the only supplier, will soon stop distributing the product.

“I don’t have a natural lens in either eye, so I wear contacts to function and need this medicine,” said Vaghar, who lives in Newton, Mass. “I’ve tried many glaucoma drugs, but it’s the only one that seems to work for people who don’t have a lens in their eye and must keep the pressure down. And for those people who need it, they really need it. There are no alternatives. But Pfizer won’t budge.”

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Aphakic glaucoma is an uncommon condition that can occur after the natural lens in the eye is removed as a result of cataract surgery, although very few people develop the problem. But for those who do, lowering the pressure in the eye is crucial, or patients are likely to lose their eyesight. Unfortunately, other glaucoma treatments on the market are often ineffective for this condition, according to ophthalmologists.

Vaghar and several other patients – in addition to parents of children who use the drops – have tried to convince Pfizer to reverse course, but so far their efforts have failed. Until recently, Pfizer declined to provide names of any manufacturing partners. Meanwhile, the patients enlisted physicians in hopes of locating another company willing to make the drops. But such a step would require regulatory approval, a challenging and time-consuming process. And time is not on their side.

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“If this goes off the market, we’ll probably have to do surgery for some patients to control their pressure. This medicine is uniquely beneficial for this kind of glaucoma,” said David Walton, a Boston ophthalmologist who treats between 40 and 50 people with aphakic glaucoma, including children for whom it is a common cause of blindness.

“They’re scared and anxious and desperate. It’s a very intense concern. And you have a big, multi-national, multibillion-dollar company that arbitrarily says it won’t make it anymore. I think it’s understandable from a Pfizer perspective. But there are things Pfizer could do to look good – make more drug or fund research to prevent the disease from recurring.”

A Pfizer spokesperson said that the drops are being discontinued due to “a complex chain of external partners” that is “increasingly unstable,” which has led to multiple shortages in recent years. Other companies supply many of the components, including active and inactive ingredients, sterilized packaging materials, technologies, and final formulation. The active ingredient in the drops is also toxic, he added, which means it requires special handling and transportation.

Moreover, Pfizer estimated there are only about 100 patients in the U.S. based on prescription data, which is another way of saying this is a small market that is fairly static and, therefore, sales are highly unlikely to increase. Pfizer does not break out sales for the eye drops and the spokesperson declined to say whether the product is profitable.

“We understand that some patients, caregivers, and ophthalmology scientific organizations are disappointed about Pfizer’s decision to discontinue Phospholine Iodide,” the spokesperson wrote us. “We did not come to this decision lightly and made every effort to inform those impacted as soon as the decision was made to allow time to seek the best alternative treatment options.”

A month’s supply may cost about $75 to $100 for patients with insurance. “But if they increased the price by a factor of 10, we would still pay it,” said Elizabeth Kinder, a TV commercial producer whose son uses the drops. “Without these eye drops, the next step is surgery, which is not curative. It’s just a form of management. It doesn’t last forever and doesn’t always work. It’s the last thing we want to do.”

The decision reflects an ongoing dilemma facing drug makers, physicians and patients. Older medicines used by a small number of people may generate little to modest revenue, sometimes forcing drug makers to coldly calculate the return on the investment made to continue production or, in this case, contracting with other companies to manufacture a product.

From a financial perspective, discontinuing such a product may make sense. At the same time, a company runs a risk of enduring bad publicity, especially when companywide sales are in the billions of dollars and goodwill can be generated by maintaining supplies. Consequently, such situations point to a need for policymakers to address such scenarios on a societal level, according to one expert.

“It sounds like a story we’ve heard before and it’s a challenging story,” explained Aaron Kesselheim, a Harvard Medical School professor, who also heads the program on regulation, therapeutics, and law at Brigham and Women’s Hospital. “It may be a rare problem, but these are the kinds of circumstances where we may need to think about alternatives for manufacturing and supplying the product.

“Sometimes, manufacturers have been encouraged to continue the supply based on public outcry. But if they’re not going to produce the product anymore as a for profit company, that’s their prerogative. But this is really a societal problem. We should be trying to develop a way of dealing with these issues so it doesn’t fall on shoulders of individual patients to bang on Pfizer’s door.”

Pfizer did acknowledge that Emergent BioSolutions (EBS) performs all of the fill and finish, which refers to filling the eye solution into bottles and then final packaging before distribution. But Emergent, which last year won contracts to help produce Covid-19 vaccines, is now embroiled in a scandal over contamination of millions of doses of the shots at its Baltimore plant and was harshly criticized by the Food and Drug Administration after an inspection last week.

Whether Emergent would be in a position to maintain its involvement with this medication is unclear. We asked the company for comment and will pass along any reply. Also unclear is whether a compounding pharmacy could step in, given the manufacturing challenges. Meanwhile, Pfizer declined to identify the company that supplies the active pharmaceutical ingredient, although AMRI confirmed that it previously filed documentation with the Food and Drug Administration to supply the ingredient in the U.S.

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

“In the old days, pharmaceutical companies would make loss leaders out of a product as a service to both doctors and patients as a goodwill effort. But nowadays, Pfizer is out of the eye care business, so there’s no incentive to produce this. I wonder whether they would be different if this was a profitable drug. Then they might find some way to minimize the manufacturing and API issues.”

  • Get Boston physician Dr. Walton to hop on the band wagon – and approach Bausch Health Care. They are specialists in ophthalmologic / eye-care drugs and products (anyone with contact lenses would know). As the users of this what seems to be miracle drug will want to keep using it, other avenues of production should be pursued. Pfizer should be shamed into disclosing to for instance Bausch so that the product can still be made. And more shame on Pfizer for getting filthy rich from Covid vaccines, yet being scrooge to all shareholders with “regular” dividends. It is making itself into a cheap, greedy, totally un-cooth business.

  • Me too. I have just written Mr. Silverman to thank him for this article. Pfizer has caused me to lose the sight in my left eye and I’ve been trying to get the word out. It was a relief to read this because I’ve been feeling completely alone in it.

    Unlike some, I have no surgical options. I lost the sight in my left eye when Phospholine Iodide became unavailable in 2019. They brought the drug back in August 2020 which meant I could at least retain light and shadow. Now it will be gone after May 1st.

    I was born with congenital glaucoma in both eyes and have no pharmaceutical or surgical alternatives. It took years to arrive at the one drug that could save my sight.

    Supply chain problems surely make this drug expensive and inconvenient. But how can a company like Pfizer, poised to make billions from its’ Covid vaccine, refuse to take a loss on a drug just because the affected group is small? Or why won’t they turn it over to a smaller, specialty company for free or with a royalty deal? My doctor tells me there are such companies interested.

    I believe Phospholine Iodide was once under the control of Merck and that the FDA put pressure on them when this withholding became an issue years ago.

    I have gotten nowhere with Pfizer, the FDA or my U.S. Senators.

    I have had many surgical procedures since childhood. As a boy I was a patient of the renowned Dr. Harold Scheie, a humanitarian who saved my sight with a procedure named for him, accepting only my police officer father’s basic insurance. I am monitored regularly and have been on numerous eye drops, in various combinations, through the years to keep my intraocular pressure under control. My right eye was always my “bad eye” in terms of vision, but its’ pressure has remained fairly controllable since Dr. Scheie’s last operation in 1968. Now that bad eye is all I have.

    In my 30s the left eye began to give me trouble and there have been many procedures, including one for a detached retina. There are no further surgical options for this eye and every conceivable combination of drugs proved ineffective until my doctor arrived at Phospholine a few years ago. I had finally found the perfect cocktail of eye drops that would keep my pressure down and preserve my sight.

    I’m disgusted with Pfizer for putting profits before people.

  • Can you take it to the Supreme Court or contact the president somebody should care another post mention the statistics can you get a petition signed I will sign it

  • That is so sad I can’t believe it he might want to check Germany they have a really good drug Market also believe it or not in India. . Don’t give up I saw the other post that somebody wrote that there is a company in the US it has the same active ingredients wow I thought Pfizer was a hero during the pandemic now I’m guessing this they’re all about the dollar

  • Shame on Pfizer! Apparently they care very little for their patients who have to use this. It’s not a therapy for a minor, inconvenient, issue, but one’s sight; without which, one needs assistance, & cannot live independently.
    I am sure if one of their family members required it, they would continue its production! Disgusting policy

  • This is Latanoprost. You can find it produced by other companies! As I found info in internet Mylan Inc still produce it in USA. Also I would recommend to see into analogs as Ksalatamax just search by active ingredient which you know! Do not give up!!!

    • It’s not latanoprost – the API is echothiophate iodide and works by an entirely different mechanism.
      Echothiophate iodide is not produced/marketed by any other company.

  • Just disgraceful…if it were one of their family members in this position I bet they wouldn’t be discontinuing the eye drops…shame on you all that made this horrible decision…just so wrong

  • Mention of Emergent of course brings the J&J vaccine – and its side-effects to mind. There the wisdom is that the blood clots only affect 1 in 1 million. (Not actually true, but we’ll pass on that.) But in this case – the need is … one in 3 million?
    And odd that if there are only 100 of these patients, one physician is Boson treats half of them? Odd and sad …

    • Hello, it may seem odd that one doctor in Boston has such a concentration of such patients, but that is because he is a super specialist in pediatric glaucoma. He is the doctor that OTHER pediatric ophthalmologists send difficult cases to. People travel from all over the world to see Dr. Walton.

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