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Eyedrop For Presbyopia

Vuity (pilocarpine 1.25%) eyedrops were approved by the FDA in 2021 for the treatment of presbyopia. It works by contracting the iris sphincter muscle to induce miosis and create a temporary pinhole effect to enhance near vision. Two phase 3 clinical trials (Gemini 1 and 2) found Vuity to be effective in improving near vision within 15 minutes for up to 6 hours with once daily use and no significant safety issues. However, case reports have linked pilocarpine use to rare retinal detachments. A dilated eye exam is recommended before prescribing Vuity, especially for patients with high myopia or retinal conditions.

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21 views26 pages

Eyedrop For Presbyopia

Vuity (pilocarpine 1.25%) eyedrops were approved by the FDA in 2021 for the treatment of presbyopia. It works by contracting the iris sphincter muscle to induce miosis and create a temporary pinhole effect to enhance near vision. Two phase 3 clinical trials (Gemini 1 and 2) found Vuity to be effective in improving near vision within 15 minutes for up to 6 hours with once daily use and no significant safety issues. However, case reports have linked pilocarpine use to rare retinal detachments. A dilated eye exam is recommended before prescribing Vuity, especially for patients with high myopia or retinal conditions.

Uploaded by

b99401114
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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Eyedrops for presbyopia

R3 莊宇勛
2022.7.29
Pilocarpine 1.25%
• Vuity
• FDA approval in 2021/10
• Treatment for presbyopia

• cholinergic muscarinic agonist


• contraction of the iris sphincter muscle
• Miosis
How to Use?
• Once daily (in the morning)

• Bilateral

• 30 days
光圈與景深
• Pinhole effect
Not just “pilocarpine” pHastTM
Proprietary Buffer
Decrease discomfort. Increase bioavailability.

Commercial pilocarpine pH=4, did not reach physiologic pH (approximately 7) in simulated tears, even after 10 minutes
Criteria
• Inclusion Criteria:
• 40-55 year old
• Subjective complaints of poor near vision
• +1 D~ -4D, cylinder <-2D
• CDVA 20/25 or above. Near vision 20/40 (J3) or 20/100(J10)
• Exclusion Criteria:
• History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any
intraocular surgery
• Use of any topical ophthalmic medications, including artificial tears other than the study medications
during the study
• Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes
• Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or
edema) in either eye that are likely to interfere with visual acuity
• Narrow iridocorneal angles (Shaffer grade ≤2 or lower on gonioscopy examination), history of angle-
closure glaucoma, or previous iridotomy
• Diagnosis of any type of glaucoma or ocular hypertension
Phase III- Gemini 1
• 323 participants
• 72.8% Female; 90.4% White
• Distance-corrected near visual acuity (DCNVA) of 20/40 (J3) to 20/100
(J10)
• Multicenter, double-masked, randomized control
• Primary End point: mesopic, high contrast, binocular DCNVA, on day 30
• At 40 cm
• Hour 3
• Gaining 3-lines
• With the same refraction correction
Waring GO 4th, Price FW Jr, Wirta D, et al. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical
Trial. JAMA Ophthalmol. 2022;140(4):363-371.
Gemini 1
• Onset: 15 min
• Duration: 6 hours
Distance Vision Acuity
• No one with an improvement of 3 lines or more in mesopic DCNVA
lost more than 5 letters in CDVA (corrected distance visual acuity)
Phase III- Gemini 2
• 427 participants (Vuity 212; vehicle: 215)
• Vuity 26% Placebo 11%
• 90% achieved 20/40 (or better) mesopic DCNVA
Gemini 2
Gemini 1
Adverse effect
• Headache(14.1%)
• conjunctiva hyperemia
• Eye irritation 2.5%

Gemini 1
Safety Information
• Contraindication: allergy
• Night driving.
• Hazardous occupation in poor illumination
• Iritis: prevent synechiae
• Rare case of retinal detachment.
• Seek medical care with sudden vision loss
Pupil diameter change

Mesopic: 10-11 lux


Photopic: > 251 lux
Cost-effectiveness
• $79 ( 台幣 2365 元 ) 含 5ml
• 頻次 QD OU
• 50 天 / 瓶 , 每天約花 47 元 , 一年約花 17000 元

80 NTD 15ml
Advantage Doubts
Milestone for treatment Long-term use? End point
for presbyopia. was 30 days of
observation?
May be used for
pseudophakic patient with Refraction change after
monofocal IOL. usage of Vuity? Myopic-
shift?
An excellent bridge to
enhance reading vision Risk of retinal detachment
until patients are ready for in high myopia patient
IOL surgery.
Retina detachment
• Miotics  long suspected of carrying a risk of retinal detachment

• Anterior displacement of the lens with associated anterior migration


of vitreous
• No serious ocular adverse effect in Gemini-1 and 2 such as retinal
detachment.

• Case series of 3 eyes from 2 patients who presented with retinal


detachments with concurrent pilocarpine 1.25% use for presbyopia.
Al-Khersan, H., Flynn, H. W., Jr, & Townsend, J. H. (2022). Retinal Detachments Associated With Topical
Pilocarpine Use for Presbyopia. American journal of ophthalmology, 242, 52–55.
Case 1
• 47M
• 1.25% Pilocarpine for one month
• Cataract surgery OD 3 months ago
• OD: +1.25-1.00 X90 OS+ 1.00 - 0.75 ×100
OS: superior horseshoe tear
• Symptoms: increased floaters OU  RRD OU

OD, inferotemporal break


Case 2
46M
• Vuity for 5 weeks
• Dilated fundus exam: cobblestone retinal degeneration OU at
temporal side
• OD: –2.50 - 1.50 ×071 OS: –2.25 - 1.00 ×090
• Nasal visual field defect OS  RRD OS
• Retina break at 1’oclock
Take Home Message
• Vuity is the first and only eyedrops for the treatment of mild to
moderate presbyopia. Clinical trial Gemini-1 and 2 show efficacy and
safety of Vuity.

• Dilated fundus exam should be performed before prescribing Vuity.


Reference
• Waring, G. O., 4th, Price, F. W., Jr, Wirta, D., McCabe, C., Moshirfar,
M., Guo, Q., Gore, A., Liu, H., Safyan, E., & Robinson, M. R. (2022).
Safety and Efficacy of AGN-190584 in Individuals With Presbyopia:
The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA
ophthalmology, 140(4), 363–371.
• Al-Khersan, H., Flynn, H. W., Jr, & Townsend, J. H. (2022). Retinal
Detachments Associated With Topical Pilocarpine Use for
Presbyopia. American journal of ophthalmology, 242, 52–55. Advance
online publication.
Thank You!

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