Pilocarpine Ophthalmic Spray for Presbyopia

(VISION-2 Trial)

No longer recruiting at 8 trial locations

Overseen By Greg Bennett, MSEd

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Eyenovia Inc.

Must not be taking: Ophthalmic medications

Disqualifiers: Glaucoma, Ocular hypertension, Cardiac disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 visits

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an eye spray called pilocarpine to determine its effectiveness for people with presbyopia, a common condition where near vision becomes blurry with age. Participants will apply either the pilocarpine spray or a placebo (a fake treatment) to their eyes and then undergo vision and eye health assessments over a few hours. The trial aims to determine if the spray safely improves close-up vision. Ideal candidates are those who struggle with near vision tasks like reading or using a phone, but not those with serious eye conditions or a history of eye surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for presbyopia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who need certain eye medications, except for artificial tears for dry eye syndrome.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that pilocarpine eye treatments are usually well-tolerated. Studies by the International Agency for Research on Cancer have found that pilocarpine does not cause cancer. However, some possible side effects exist. For instance, if the eye medicine becomes contaminated, it could cause serious eye damage or even vision loss.

To prevent this, keep the container tightly closed. While pilocarpine is considered "toxic" if swallowed in large amounts, this study uses a spray for the eyes, which differs. Remember, any medicine can have side effects, so it's important to be informed and follow instructions carefully. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for presbyopia, which often involve reading glasses or contact lenses, pilocarpine ophthalmic spray is unique because it offers a non-invasive way to temporarily improve near vision. This spray uses a 2% pilocarpine solution delivered through the innovative Optejet dispenser, which allows for precise application directly to the eyes. Researchers are excited about this treatment because it could offer a quick and convenient alternative for those who want to avoid traditional corrective lenses.

What evidence suggests that Pilocarpine Ophthalmic might be an effective treatment for eye conditions?

Research has shown that pilocarpine in an eye spray can assist people with presbyopia, a condition where close-up vision becomes difficult with age. In earlier studies, a 1.25% pilocarpine spray improved near vision for up to 30 days. Many participants could read two to three lines better on vision charts just three hours after application. This indicates that pilocarpine can enhance vision in the short term and may be beneficial for longer durations. In this trial, participants will receive a slightly stronger 2% pilocarpine ophthalmic spray, which could yield even better results. ^{6 7 8 9 10}

Who Is on the Research Team?

Tsontcho (Sean) Ianchulev, MD, MPH

Principal Investigator

Eyenovia Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Poor near vision impacting daily living that requires near correction

Primary

Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants self-administer 1 of the 2 study treatments to both eyes during each of the 2 treatment visits

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for efficacy and safety assessments over a 3-hour period post-treatment

3 hours

What Are the Treatments Tested in This Trial?

Interventions

• Pilocarpine Ophthalmic
• Placebo

How Is the Trial Designed?

Group I: Pilocarpine 2% Ophthalmic Spray Experimental Treatment 1 Intervention

2% pilocarpine ophthalmic spray administered with the Optejet dispenser

Group II: Placebo Spray Placebo Group 1 Intervention

Placebo ophthalmic spray administered with the Optejet dispenser

Who Is Running the Clinical Trial?

Eyenovia Inc.

Lead Sponsor

Trials

9

Recruited

950+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40880143/

Efficacy and safety of pilocarpine hydrochloride ophthalmic ...

Pilocarpine 1.25% effectively improves near vision in presbyopia, with sustained benefits up to day 30 and potential long-term adaptability.

2.

ajo.com

ajo.com/article/S0002-9394(25)00439-8/abstract

Short-Term Efficacy and Safety of Pilocarpine Ophthalmic ...

Efficacy outcomes were the gain of ≥3 lines and ≥2 lines in mesopic, high-contrast binocular distance-corrected near visual acuity (DCNVA) at 3 hours postdose ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002939425004398

Short-Term Efficacy and Safety of Pilocarpine Ophthalmic ...

Efficacy outcomes were the gain of ≥3 lines and ≥2 lines in mesopic, high-contrast binocular distance-corrected near visual acuity (DCNVA) at 3 hours postdose ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03804268

NCT03804268 | Efficacy Study of Pilocarpine HCl ...

Participants received one drop of pilocarpine HCl ophthalmic solution 1.25% in each eye, once daily, for up to 30 days. Intervention/Treatment, Drug : ...

5.

journals.lww.com

journals.lww.com/ijo/fulltext/2025/09000/efficacy_and_safety_of_pilocarpine_hydrochloride.4.aspx

Efficacy and safety of pilocarpine hydrochloride ophthalmic ...

Conclusion: Pilocarpine 1.25% effectively improves near vision in presbyopia, with sustained benefits up to day 30 and potential long-term adaptability.

6.

medline.com

medline.com/media/catalog/Docs/MSDS/MSD_SDSD16359.pdf

SAFETY DATA SHEET

International Agency for Research on. Cancer (IARC):. Not considered to be a carcinogen. Page 7. SAFETY DATA SHEET. Pilocarpine Hydrochloride Ophthalmic ...

7.

somersetpharma.com

somersetpharma.com/wp-content/uploads/2023/12/SDS-pilocarpine.pdf

Pilocarpine HCL ophthalmic solution, USP

TOXICITY: The oral-rat LD50 for pilocarpine is: 200 MG/KG. Pilocarpine is classified a "toxic" by OSHA.

8.

sigmaaldrich.com

sigmaaldrich.com/sds/SIGMA/P6503?srsltid=AfmBOoqk4pR9EVkMNTbpWgWeXTGv9pFD-wtsF8fy5v7NLxnW0EYMMbXU

SAFETY DATA SHEET

Product is sensitive to light and moisture. Storage class. Storage class (TRGS 510): 6.1A: Combustible, acute toxic Cat. 1 and 2 / very toxic.

9.

mayoclinic.org

mayoclinic.org/drugs-supplements/pilocarpine-ophthalmic-route/description/drg-20065516

Pilocarpine (ophthalmic route) - Side effects & dosage

Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.

10.

mmbio.byu.edu

mmbio.byu.edu/0000017e-0db3-d5d4-a57f-0df3ea260000/pilocarpine-hydrochloride-pdf

Pilocarpine hydrochloride

OSHA: No component of this product present at levels greater than or equal to 0.1% is on OSHA's list of regulated carcinogens.