Will FDA approved phentolamine ophthalmic solution 0.75% eye drops impact pediatric care?


In this Contemporary Pediatrics® interview, Rupa Wong, MD, discusses the recent FDA approval of phentolamine ophthalmic solution 0.75% eye drops to treat pharmacologically-induced mydriasis, and how this could impact the treatment landscape for the pediatric population. [Editor's note: RYZUMVI was previously known as Nyxol, which is referenced in the interview.]

Rupa Wong, MD, managing partner, Honolulu Eye Clinic, clinical associate professor, University of Hawaii John A. Burns School of Medicine, details the FDA approval of phentolamine ophthalmic solution 0.75% eye drops (RYZUMVI; Ocuphire Pharma and Viatris).

Interview highlights

  • Rupa Wong, MD, is a board-certified pediatric ophthalmologist.
  • The FDA approved phentolamine ophthalmic solution 0.75% eye drops for pharmacologically-induced mydriasis.
  • Pediatric ophthalmologists often use cyclopentolate, which was not studied in the relevant clinical trials, to paralyze the focusing muscles in children.
  • Cyclopentolate is preferred over tropicamide for younger children to determine their refractive error accurately.
  • The FDA approval of phentolamine eye drops may benefit older children who do not require cycloplegia and want to reduce light sensitivity during exams or outdoor activities.

Interview transcript (edited for clarity):

Rupa Wong, MD:

I am Dr. Rupa Wong, I am a board certified pediatric ophthalmologist, managing partner of Honolulu eye clinic, and clinical assistant professor at the University of Hawaii School of Medicine.

Contemporary Pediatrics:

What is your reaction to the FDA approval of phentolamine ophthalmic solution 0.75% eye drops, to treat pharmacologically-induced mydriasis, and why?


I know there is a lot of excitement about this eye drop it hasn't been in existence since the previous type of eye drop, called REV-EYES was also introduced to be able to reduce the dilation effect. The thing is, I don’t think there is going to be that much that changes in terms of the pediatric patient population. The reason for this is most pediatric ophthalmologists, we don’t just dilate the pupil, as is done for adults to examine the inside of the eye, we’re actually also cyclopleging the children. Cycloplegia means paralyzing the focusing muscle of the eye. The reason for that is it helps us uncover the true refractive error for children. We use a drop called cyclopentolate in various concentrations depending on the age of the child,” Wong said. “That actually was not studied in the [phentolamine ophthalmic solution 0.75%] clinical trials, so we don’t know if it is going to reverse. I don’t think it will because phentolamine ophthalmic solution 0.75% is an alpha-type antagonist, as opposed to the muscarinic acetylcholine receptors that are helping with the focusing muscles. I don't know if it's going to really change much of our practice and pediatric ophthalmologists, since we don't have any data that it's going to work with the eyedrops that we actually use in clinical practice. They were specifically looking at reversing three drops, phenylephrine eye drops, tropicamide eyedrops, and then a combo drop called Paremyd. These are drops that are typically used in the adult population. So yes, though they were studying the [phentolamine ophthalmic solution 0.75%] eyedrops in pediatric patients, they weren't using it with an endpoint of seeing if it reversed the dilation caused by the drop we actually use in that pediatric patient population.

Contemporary Pediatrics:

Can you further explain why cyclopentolate is often used for younger children as opposed to tropicamide?


The reason that we use the stronger cyclopentolate eyedrops, as opposed to the tropicamide eyedrop that they studied, is it's really essential to paralyze the focusing muscles in children when trying to determine the refractive error. So as an adult, if you go in to get your eyes checked, they put you behind the phoropter and they say, "what's better 1 or 2?" We obviously cannot do that with infants or even young kids, and there's a tendency for young kids to like extra minus prescription, it just helps them see clearly. So, unless we paralyze that focusing muscle, we run the risk of getting a prescription that is too strong or even unnecessary. This is really pretty standard for most pediatric ophthalmologists to use cyclopentolate eyedrops in the office. Some will use tropicamide, but maybe in a stronger concentration in terms of stronger frequency pattern than we do in adults. So, I don't know if this is really going to change the way that most of us practice, if we're going to actually offer it to pediatric patients. In the older age, which they did study of children, it certainly might be something that could be used some of those we don't need cycloplegia, which is paralyze the focusing muscles, we can use the more adult dilating drops. That's what I do in the office because the purpose of those drops are twofold, one to make the pupil large so that we can examine the inside of the eye and that's what these reversal eyedrops are doing, they're negating that effect, and then the second is to paralyze the focusing muscle. If we have an older kid that we're not too concerned about, if they have strabismus or amblyopia or uncorrected refractive error, if they're pretty much routine eye exam, then some doctors might tend towards using the older types of eyedrops the tropicamide and phenylephrine, which were studied in these clinical trials of [phentolamine ophthalmic solution 0.75%]. So, for those patients, I think it might be a benefit. I live in Hawaii, a lot of kids want to get back out into the beach, they want to get back out to do their outdoor activities, and the larger pupil makes that really challenging because it makes them very light sensitive. I think for the older kids, certainly that [this FDA approval] might be a possibility it might be really helpful.

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