On this episode of Presbyopia Playbook, Mark Schaeffer, OD, FAAO, is joined by Maria Pribis, OD, FAAO, to discuss the adverse event profile of pilocarpine eye drops for presbyopia, with a focus on screening, patient selection, and counseling that precedes a prescription.
Dr. Schaeffer is Clinical Excellence Captain at MyEyeDr in Birmingham, Alabama. Dr. Pribis is in practice at Stamford Ophthalmology in Stamford, Connecticut.
Pilocarpine fast facts
- FDA-approved pilocarpine formulations for the treatment of presbyopia in adults include:
- VUITY (Allergan/AbbVie): Pilocarpine HCl ophthalmic solution 1.25%
- QLOSI (Orasis Pharmaceuticals): Pilocarpine HCl ophthalmic solution 0.4%
- Most common adverse reactions based on clinical trials:1,2
- VUITY: Headache and conjunctival hyperemia
- QLOSI: Instillation site pain and headache
- Product warnings: Both labels warn that rare cases of retinal detachment have been reported with miotics. Individuals with pre-existing retinal disease are at increased risk.1,2
- Dilated fundus examination is recommended as part of individual risk assessment before prescribing miotics for presbyopia.3
Common adverse events of pilocarpine drops
Dr. Pribis discussed concentration and pilocarpine tolerability, noting that since the lower-concentration pilocarpine formulation became available, she has observed a few commonly reported side effects in her practice.
"Never will I ever say, 'Call me if you have any issues.' I hate patient phone calls that I could have prevented," she explained. "So my goal is to tell the patients what's normal ... and then what is actually dangerous."
Burning
Burning has been the most commonly reported side effect in Dr. Pribis' practice. She characterizes it as transient, typically resolving within seconds to a few minutes. Dr. Pribis frames it for patients as part of how the drug penetrates and begins to work, typically within 20 minutes after instillation.2
Transient dimming
Transient dimming was the second effect Dr. Pribis routinely discusses with her patients. She added that one patient described the experience as "a storm rolling in and then rolling out," a description she now uses with other patients to convey the visual quality and limited duration of the effect.
"I think it's important for us when we're talking about prescribing medications, what can happen and how we can help educate our patients so that they know what to expect," Dr. Shaeffer added. "Because when we set expectations, we get to help drive that conversation and drive that experience."
Headache
Headache is the third adverse effect Dr. Pribis addresses in her standard counseling. Of the patients in her practice who discontinue pilocarpine, most do so because of a long-lasting headache rather than burning or other common side effects.
She tells patients that headaches are generally transient, but that a prolonged headache likely indicates they are not a good candidate for continued use.
Both product labels report adverse event rates consistent with what Dr. Pribis describes:
- VUITY: Adverse events reported in the GEMINI 1 and GEMINI 2 trials:¹
- Greater than 5% of participants report headache and conjunctival hyperemia
- 1 to 5% of participants report blurred vision, eye pain, visual impairment, eye irritation and increased lacrimation
- QLOSI: Adverse events reported in the NEAR-1 and NEAR-2 trials:²
- 5 to 8% of patients: instillation site pain, headache
- 2 to 5% of patients: blurred vision
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Patient selection and screening
Dr. Pribis described firm screening criteria. She does not prescribe pilocarpine to high myopes or to patients with prior LASIK and an elongated axial length. Her practice cutoffs are an axial length >26.5mm or a refractive error >–6.00D, using A-scan measurements when available.
Dr. Pribis referenced newer VUITY data showing a lower likelihood of ciliary muscle movement, but, in her view, she still maintains her cutoff to be safe. To date, she reported no cases of retinal tear or detachment in her patients on these drops. Dr. Schaeffer emphasized that every candidate should undergo a dilated fundus evaluation or other retinal examination prior to initiation.
This aligns with the prescribing information for both VUITY and QLOSI, each of which warns that:1,2
- Rare cases of retinal detachment have been reported with miotics
- Individuals with pre-existing retinal disease are at increased risk
- Examination of the retina is advised in all patients prior to the initiation of therapy
The 2022 ASCRS Consensus Statement on VUITY similarly recommends considering a dilated fundus examination as part of individual risk assessment before prescribing miotics for presbyopia, with OCT of the macula as an additional option based on clinical context.3
In one case of thinking outside the box for appropriate patient selection, Dr. Pribis described a surgical colleague who had proposed pilocarpine for an unhappy multifocal IOL patient with slightly large pupils. Because the patient had been a –8.00D myope pre-operatively, brimonidine was used instead to achieve a miotic effect without the cholinergic agonist–related risks.
Pilocarpine as an addition to glasses and contact lenses
Dr. Pribis described pilocarpine as an option she introduces alongside eyeglasses and contact lenses. She positions it as an "and," usable for specific situations such as social events or presentations, rather than as a replacement for existing correction.
Before providing the pilocarpine prescription, Dr. Pribis covers four points with patients, drawing on her clinical experience as well as the patient counseling sections of both the VUITY and QLOSI prescribing information:1,2
- Brief burning on instillation
- Transient dimming
- The possibility of headache
- A low risk of retinal complications, with instructions to contact the office immediately in case of sudden floaters, flashes, or a curtain in the vision
Key takeaways
- Examination of the retina is advised in all patients prior to initiation of therapy with pilocarpine for presbyopia.1,2,3
- Both labels carry warnings regarding rare retinal detachment with miotics. Both note increased risk in patients with pre-existing retinal disease.1,2
- Dr. Pribis does not prescribe pilocarpine to patients with axial length greater than 26.5mm or more than 6.00D of myopia, and considers history of refractive surgery in that calculation.
- Proactive counseling on common adverse events, including burning, dimming, and headache, may help reduce post-instillation patient calls, according to Dr. Pribis' experience.
This article was written by Sonia Kelley, OD, MS, based on the recorded video from Drs. Schaeffer and Pribis.
