Ophtesic (Lidocaine Eye Gel)
Topical ophthalmic anesthetic gel for eye procedures
Quick Facts About Ophtesic
Key Takeaways About Ophtesic
- Professional use only: Ophtesic is applied by your doctor or eye specialist before ophthalmic procedures — it is not a medicine you administer yourself at home
- Rapid onset: The anesthetic effect begins within approximately 5 minutes of application, numbing the eye surface for painless procedures
- Single-use product: Each tube is sterile and designed for one-time use only — it must be discarded immediately after the procedure
- Temporary blurred vision: You may experience blurred vision after use — do not drive or operate machinery until your vision has fully returned to normal
- Not for prolonged use: Repeated or prolonged application of topical ophthalmic anesthetics can damage the cornea and delay healing
What Is Ophtesic and What Is It Used For?
Ophtesic is a topical anesthetic eye gel containing lidocaine hydrochloride (20 mg/g) that produces temporary surface anesthesia of the eye. It is used by healthcare professionals to numb the eye before ophthalmic examinations and procedures, taking effect within approximately 5 minutes of application.
Ophtesic belongs to the class of local anesthetics known as amide-type agents. Lidocaine, the active ingredient, is one of the most widely used and well-studied local anesthetics in medicine, with a long history of safe and effective use in ophthalmology. When applied topically to the eye as a gel, it reversibly blocks sodium channels in the sensory nerve endings of the cornea and conjunctiva, preventing the generation and conduction of nerve impulses. This action produces a temporary loss of sensation (numbness) in the eye, allowing the physician to perform various procedures without causing pain or discomfort to the patient.
The gel formulation offers several advantages over traditional anesthetic eye drops. Because the gel has a higher viscosity than drops, it remains in contact with the eye surface for a longer period, providing more uniform and prolonged anesthesia. Studies published in the British Journal of Ophthalmology have shown that lidocaine gel produces comparable or superior anesthesia to liquid formulations for many ophthalmic procedures, with the added benefit of acting as a coupling medium during certain examinations.
Ophtesic is indicated for use in a wide range of ophthalmic procedures, including but not limited to:
- Tonometry — measurement of intraocular pressure (important for glaucoma screening)
- Gonioscopy — examination of the drainage angle of the eye
- Foreign body removal — extraction of particles or debris from the eye surface
- Minor surgical procedures — such as superficial corneal scraping or conjunctival biopsy
- Contact lens fitting — specialized examinations for rigid contact lenses
- Diagnostic staining — procedures requiring application of fluorescein dye
- Cataract surgery preparation — used as part of a combined anesthetic protocol
It is important to understand that Ophtesic is strictly for professional clinical use. It is applied by your ophthalmologist or other qualified healthcare professional in a clinical setting. This medicine is not intended for self-administration at home, and prolonged or unsupervised use of topical ophthalmic anesthetics can lead to serious corneal damage including epithelial erosion, stromal infiltration, and delayed wound healing. The European Medicines Agency (EMA) and the World Health Organization (WHO) classify lidocaine as an essential local anesthetic agent, underscoring its importance in clinical practice.
Lidocaine blocks voltage-gated sodium channels in sensory nerve fibers. When applied to the eye surface, it prevents nerve impulses from traveling from the cornea and conjunctiva to the brain, so you temporarily cannot feel pain or touch in the treated area. The effect is fully reversible, and normal sensation returns as the drug is naturally cleared from the tissue.
What Should You Know Before Using Ophtesic?
Ophtesic should not be used if you are allergic to lidocaine, other amide-type local anesthetics, or any of the inactive ingredients. Your doctor will assess your medical history and current medications before deciding to use this product.
Contraindications
You must not receive Ophtesic if you have a known allergy (hypersensitivity) to lidocaine hydrochloride, to other amide-type local anesthetics such as bupivacaine, mepivacaine, prilocaine, or ropivacaine, or to any of the other ingredients in this medicine (listed in the composition section below). Allergic reactions to amide-type local anesthetics are rare but can include contact dermatitis, urticaria, or in very rare cases anaphylaxis. If you have previously experienced an adverse reaction to any local anesthetic, inform your doctor before any procedure.
There is an important distinction between amide-type and ester-type local anesthetics. If you are allergic to ester-type anesthetics (such as tetracaine, proparacaine, or procaine), this does not necessarily mean you will react to Ophtesic, as cross-reactivity between the two classes is extremely rare. However, you should always disclose any drug allergies to your healthcare provider so they can make an informed decision.
Warnings and Precautions
Several important warnings apply to the use of Ophtesic:
- For ophthalmic use only: Ophtesic is designed exclusively for application to the eye. It must not be injected, swallowed, or applied to other body areas.
- Prolonged use risk: Extended or repeated use of topical ophthalmic anesthetics can cause corneal opacity (clouding of the clear front surface of the eye). This condition, known as anesthetic keratopathy, can impair vision and may not be fully reversible. For this reason, Ophtesic is used only for specific procedures and never prescribed for ongoing pain management.
- Corneal protection: After the anesthetic takes effect, your eye cannot feel pain or detect foreign objects. Take special care to protect your eyes from accidental injury, dust, or wind until the anesthetic wears off completely. Do not rub your eyes during this period.
- Single-use product: The 3.5 g single-dose tube is sterile and intended for one-time use only. Using a previously opened tube risks introducing bacteria into the eye and may cause serious infection. Your doctor will discard the tube and blister packaging immediately after the procedure.
- Contact lens wearers: Do not insert contact lenses while the eye is still numb, as you may not feel whether the lens is positioned correctly or causing irritation.
Never use Ophtesic or any topical anesthetic eye drops/gel at home to treat eye pain. Self-administration of these products can mask symptoms of serious eye conditions, delay proper treatment, and lead to permanent corneal damage. If you are experiencing eye pain, consult your doctor or ophthalmologist promptly.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before Ophtesic is used. Lidocaine is known to cross the placental barrier. However, the systemic absorption of lidocaine from a single topical ophthalmic application is minimal, and the amount reaching the bloodstream is extremely small compared to other routes of administration such as injection or dental anesthesia.
Lidocaine is excreted in breast milk in small amounts. Given the very low systemic absorption from ophthalmic use, the risk to a nursing infant is considered negligible. The World Health Organization considers lidocaine compatible with breastfeeding when used in standard clinical doses. Nevertheless, your doctor will weigh the potential benefits of the procedure against any theoretical risk before proceeding.
There are no adequate and well-controlled studies of topical ophthalmic lidocaine specifically in pregnant women. Animal reproduction studies have not demonstrated fetal harm at clinically relevant doses. Your healthcare provider will use clinical judgment to determine whether the benefits justify the use of Ophtesic during pregnancy.
Driving and Operating Machinery
You may experience temporary blurred vision following the application of Ophtesic. This is a normal and expected effect of the gel formulation contacting the eye surface. You should not drive a vehicle, ride a bicycle, or operate machinery until your vision has returned to normal. The duration of visual disturbance varies but typically resolves within 30 minutes to one hour after the gel is rinsed from the eye.
In addition to blurred vision, the temporary loss of the protective blink reflex and reduced tear sensation means your eye is more vulnerable to drying, dust, and accidental injury. Avoid exposure to wind, bright sunlight, or dusty environments until full sensation has returned. Your doctor will advise you when it is safe to leave the clinic.
How Does Ophtesic Interact with Other Drugs?
Ophtesic has minimal systemic absorption, so significant drug interactions are rare. However, inform your doctor about all medicines you are taking, including other eye drops, as concurrent use of certain medications may affect the procedure or the anesthetic effect.
Because Ophtesic is applied topically to the eye and the systemic absorption of lidocaine from this route is minimal (typically less than 5% of the applied dose reaches the bloodstream), clinically significant drug interactions are uncommon. Unlike injectable lidocaine, which can interact with antiarrhythmic drugs, beta-blockers, and CYP1A2 inhibitors at therapeutic plasma concentrations, ophthalmic lidocaine rarely achieves the blood levels necessary for such interactions to occur.
Nonetheless, it is important to inform your healthcare provider about all medications you are currently using, including:
- Other ophthalmic medications: Some eye drops may affect the pH or surface chemistry of the eye, potentially altering the onset or duration of Ophtesic's anesthetic effect. Your doctor will manage the timing and order of any additional eye medications.
- Preservative-containing eye drops: Some eye drops contain preservatives such as benzalkonium chloride that may interact with the gel formulation. Your doctor will advise on the appropriate intervals between different eye medications.
- Other local anesthetics: If you have recently received another local anesthetic (for dental work, skin procedures, etc.), inform your doctor. Although the systemic absorption from ophthalmic use is very low, the theoretical risk of additive effects exists.
| Drug/Class | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Other local anesthetics | Additive effect | Low (minimal systemic absorption) | Inform doctor of recent anesthetic use |
| Ophthalmic beta-blockers (e.g., timolol) | May alter corneal permeability | Low | Allow interval between applications |
| Preservative-containing eye drops | May affect gel stability | Low | Doctor manages application timing |
| Antiarrhythmic agents (Class I) | Theoretical additive cardiac effect | Very low (negligible systemic levels) | No dose adjustment needed |
| Sulfonamide antibiotics | No significant interaction | None | Can be used concurrently |
The key principle to remember is that topical ophthalmic lidocaine results in very low systemic exposure. The risk of systemic drug interactions is therefore substantially lower than with other routes of lidocaine administration. Your ophthalmologist will have a complete picture of your medication list and can make adjustments as necessary.
What Is the Correct Dosage of Ophtesic?
Ophtesic is applied by your doctor, not self-administered. The standard dose is approximately 1 gram of gel spread over the eye surface and surrounding area 5 minutes before the procedure. No more than one tube should be used per eye per procedure.
Ophtesic is administered exclusively by your ophthalmologist or other qualified healthcare professional. You will not need to manage the dosing yourself. The following information is provided for your understanding and awareness of what to expect during the procedure.
Standard Dosing Protocol
The recommended dose is approximately 1 gram of Ophtesic gel (equivalent to roughly one-third of the 3.5 g tube), which is applied directly to the surface of the eye and the surrounding tissue (adnexa). This amount is generally sufficient to produce adequate anesthesia for most procedures. Your doctor will apply the gel and allow it to remain on the eye for 3 to 5 minutes before rinsing it off and beginning the procedure.
Adults
Dose: Approximately 1 g of gel per eye (about one-third of the tube)
Application: Spread over the eye surface and adnexa by the physician
Wait time: 3–5 minutes before rinsing and starting the procedure
Maximum: No more than 1 tube (3.5 g) per eye per individual procedure
Reapplication: Additional gel may be applied during longer procedures to maintain anesthesia
Elderly Patients
No specific dose adjustment is required for elderly patients. However, the corneal epithelium may be more fragile in older individuals, and the physician will take care to use the minimum effective amount. Elderly patients may also have slower clearance of the drug, potentially resulting in a slightly longer duration of anesthesia.
Pediatric Use
The safety and efficacy of Ophtesic in children have not been specifically established through dedicated clinical trials. When used in pediatric patients, the dose is adjusted by the physician based on the size of the eye and the nature of the procedure. Lidocaine is generally considered safe for topical ophthalmic use in children under appropriate medical supervision.
How Ophtesic Is Applied
Your doctor will follow a standardized procedure to ensure sterile and effective application:
- Preparation: The blister packaging is opened and the tube and nozzle are removed from the sterile blister. Both components are inspected for integrity.
- Assembly: The nozzle is screwed onto the tube threading and turned clockwise to puncture the aluminum membrane seal.
- Application: With the tube pointing downward, the doctor gently squeezes the side of the tube to dispense gel, covering the eye surface and surrounding area (adnexa).
- Wait period: The gel is left in place for 3 to 5 minutes to allow the anesthetic to take full effect.
- Rinse: Before proceeding, the gel is rinsed from the eye with sterile saline solution. The nozzle tip must never touch the eye or eyelid directly.
- Disposal: The tube and blister packaging are immediately discarded after use in accordance with clinical waste protocols.
For longer procedures, additional gel may be applied during the course of the intervention to maintain adequate anesthesia. The decision to reapply is based on the physician's clinical assessment of the patient's comfort and the duration of the procedure.
Overdose
Due to the low concentration (20 mg/g) and the limited amount applied (typically 1 g or 20 mg of lidocaine per eye), systemic overdose from ophthalmic use of Ophtesic is extremely unlikely. For comparison, the maximum recommended systemic dose of lidocaine for infiltration anesthesia is 4.5 mg/kg body weight (approximately 300 mg for a 70 kg adult), far exceeding the amount used in this preparation.
In the unlikely event of excessive systemic absorption, symptoms of lidocaine toxicity may include numbness of the tongue and lips, lightheadedness, visual disturbances, muscular twitching, and in severe cases, convulsions or cardiac arrhythmias. Your healthcare professional is trained to recognize and manage such events, though they are virtually unprecedented with topical ophthalmic use at recommended doses.
What Are the Side Effects of Ophtesic?
Like all medicines, Ophtesic can cause side effects, although not everyone experiences them. The most commonly reported effects include temporary eye redness, burning sensation, and corneal changes. These are typically mild and resolve on their own.
The side effects reported with Ophtesic are generally localized to the eye and are transient in nature. Because this medicine is applied as a single dose in a clinical setting, most adverse effects resolve within hours of the procedure. The frequency of most side effects is classified as "not known" (cannot be estimated from the available data), as post-marketing surveillance data are limited for this specific formulation.
The following side effects have been reported in clinical use and post-marketing surveillance:
Eye-Related Side Effects
Frequency not known (cannot be estimated from available data)
- Conjunctival redness (bloodshot appearance) — the most common reaction, typically mild and resolving within hours
- Changes in the corneal epithelium — superficial, transient changes to the outer layer of the cornea detectable on examination
- Burning sensation in the eyes — a brief stinging feeling upon initial application that typically subsides within seconds
- Keratitis (inflammation of the cornea) — reported with repeated use; single-dose use carries very low risk
- Corneal edema (swelling of the cornea) — temporary swelling that resolves as the drug effect wears off
Systemic Side Effects
Rare with topical ophthalmic use
- Headache — reported infrequently, usually mild and self-limiting
Allergic Reactions
Very rare
- Contact dermatitis — localized skin reaction around the eye
- Hypersensitivity reactions — including urticaria (hives), itching, or swelling
- Anaphylaxis — extremely rare with lidocaine; your healthcare team is equipped to manage this
It is important to distinguish between the expected pharmacological effects of the drug and true side effects. After application, the eye will be numb and you may experience blurred vision — these are the intended effects of the anesthetic, not side effects. True adverse effects are unwanted reactions that go beyond the expected therapeutic outcome.
The risk of corneal toxicity increases significantly with prolonged or repeated use of topical ophthalmic anesthetics. This is why Ophtesic is strictly a single-dose, professional-use product. Corneal toxicity from abuse of topical anesthetics is well documented in the medical literature and can cause persistent epithelial defects, stromal infiltrates, ring-shaped keratitis, and permanent vision loss. A study published in Cornea (2019) found that patients who self-administered topical anesthetics for chronic eye pain were at significant risk of severe corneal damage.
Contact your eye doctor if you experience persistent eye redness, pain, or visual changes that last more than 24 hours after the procedure. While most side effects resolve quickly, persistent symptoms may indicate an issue that requires medical attention. If you experience signs of an allergic reaction such as swelling of the face, difficulty breathing, or widespread rash, seek emergency medical care immediately.
Reporting Side Effects
Reporting suspected side effects after a medicine has been authorized is important. It allows continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority. In the European Union, reports can be submitted through the national reporting systems of each member state. In the United States, adverse events can be reported to the FDA MedWatch program. In the United Kingdom, reports are submitted through the Yellow Card Scheme.
How Should You Store Ophtesic?
Store Ophtesic below 25°C (77°F), out of the reach of children. Do not use after the expiry date. The product is for single use only and must be discarded immediately after the procedure.
Proper storage of Ophtesic is essential to maintain the sterility and efficacy of the product. Although in most cases this medicine is stored and handled by healthcare facilities rather than patients, the following guidelines apply:
- Temperature: Store at or below 25°C (77°F). Do not freeze. Do not expose to excessive heat or direct sunlight, as this may degrade the active ingredient or alter the gel consistency.
- Keep out of reach of children: Store in a location where children cannot access the product. Accidental ingestion or eye application by a child without medical supervision could be harmful.
- Expiry date: Do not use after the expiry date printed on the tube and outer carton (after "EXP"). The expiry date refers to the last day of the indicated month. Using expired medicine may result in reduced efficacy or increased risk of microbial contamination.
- Single-use only: The product is intended for a single application and must be discarded immediately after use, even if gel remains in the tube. Do not save unused portions for later use.
- Proper disposal: Do not dispose of this medicine in wastewater or household waste. Return unused or expired medicines to a pharmacy for safe disposal in accordance with local environmental regulations.
The sealed blister packaging protects the tube and nozzle from environmental contamination before use. Do not use the product if the blister packaging appears damaged, opened, or compromised in any way. Your healthcare provider will check the packaging integrity before use.
What Does Ophtesic Contain?
Ophtesic contains lidocaine hydrochloride (anhydrous) 20 mg per gram of gel as the active ingredient, along with a small number of well-characterized excipients that form the gel base.
Understanding the full composition of Ophtesic is important for identifying potential allergens and for healthcare professionals managing patients with known sensitivities. The formulation is intentionally simple, containing a minimal number of excipients to reduce the risk of adverse reactions.
Active Ingredient
Lidocaine hydrochloride (anhydrous): 20 mg per 1 gram of gel. Lidocaine is a well-established amide-type local anesthetic first synthesized in 1943 by Nils Löfgren and Bengt Lundqvist. It is listed on the WHO Model List of Essential Medicines and is one of the most widely used local anesthetics worldwide. In this formulation, the hydrochloride salt form is used because it is water-soluble and stable in aqueous gel preparations.
Inactive Ingredients (Excipients)
| Ingredient | E Number | Function |
|---|---|---|
| Hypromellose (Hydroxypropyl methylcellulose) | E464 | Gel-forming agent — provides the viscous gel consistency that keeps the formulation in contact with the eye surface |
| Sodium hydroxide | E524 | pH adjustment — used to adjust the gel to a physiologically appropriate pH for comfort and stability |
| Hydrochloric acid | E507 | pH adjustment — used in combination with sodium hydroxide to achieve the optimal pH range |
| Water for injections | — | Solvent — high-purity water that forms the base of the gel formulation |
Notably, Ophtesic does not contain preservatives such as benzalkonium chloride, which is commonly found in multi-dose eye preparations and is known to cause irritation and corneal toxicity with repeated use. The preservative-free, single-dose design is an advantage for ocular surface health, particularly in patients who may be sensitive to preservatives or who have pre-existing corneal conditions.
Physical Characteristics
Ophtesic is a clear, colorless gel packaged in a 3.5 gram aluminum tube with a separate nozzle attachment, all enclosed in a sterile blister. The product is available in cartons containing 1, 20, or 100 tubes, though not all pack sizes may be marketed in every country. The gel is smooth, transparent, and free of particles when inspected visually.
Frequently Asked Questions About Ophtesic
Ophtesic is a topical anesthetic eye gel containing lidocaine hydrochloride (20 mg/g). It is used by healthcare professionals to produce temporary surface anesthesia (numbness) of the eye before ophthalmic examinations and procedures such as tonometry, gonioscopy, foreign body removal, and minor surgical interventions. The gel is applied directly to the eye surface and takes effect within approximately 5 minutes.
Ophtesic begins to produce anesthesia within approximately 5 minutes of being applied to the eye surface. The doctor will apply the gel and then wait 3 to 5 minutes before rinsing it off and beginning the procedure. The duration of the anesthetic effect depends on the individual and the procedure, but typically lasts long enough for most routine ophthalmic examinations and minor interventions. Additional gel can be applied for longer procedures.
Reported side effects include conjunctival redness (bloodshot appearance), changes in the corneal epithelium, a brief burning sensation upon application, inflammation of the cornea (keratitis), corneal swelling (edema), and headache. These effects are generally mild and temporary. Prolonged or repeated use — which is not the intended use of this product — can cause more serious corneal damage. Allergic reactions to lidocaine are very rare.
You may experience temporary blurred vision after Ophtesic is applied. Do not drive a vehicle, ride a bicycle, or operate machinery until your vision has returned to normal. The blurred vision typically resolves within 30 minutes to one hour after the gel is rinsed from the eye. Additionally, while the eye is numb, the protective blink reflex is reduced, so take extra care to protect your eyes from dust, wind, and accidental injury.
Lidocaine can cross the placenta, but the systemic absorption from a single topical ophthalmic application is very low. The World Health Organization considers lidocaine compatible with breastfeeding at standard clinical doses. There are no specific studies on ophthalmic lidocaine in pregnant women, but the minimal systemic exposure makes the risk very low. Always inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding, so they can weigh the benefits and risks.
No. Ophtesic is strictly for professional clinical use and requires a prescription. Self-administering topical anesthetic eye drops or gels for eye pain is dangerous and can lead to severe corneal damage, delayed wound healing, and permanent vision loss. If you are experiencing eye pain, consult your doctor or ophthalmologist. They will diagnose the underlying cause and provide appropriate treatment.
References
- European Medicines Agency (EMA). Summary of Product Characteristics: Lidocaine ophthalmic preparations. EMA Clinical Assessment Reports. Available at: www.ema.europa.eu
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Lidocaine listed as an essential local anesthetic. WHO Technical Report Series. Available at: www.who.int
- Amiel H, Koch PS. Tetracaine hydrochloride 0.5% versus lidocaine 2% jelly as a topical anesthetic agent in cataract surgery. Journal of Cataract & Refractive Surgery. 2007;33(1):98-100.
- Assia EI, Pras E, Yehezkel M, et al. Topical anesthesia using lidocaine gel for cataract surgery. Journal of Cataract & Refractive Surgery. 1999;25(5):635-639.
- Pharmakakis NM, Katsimpris JM, Melachrinou MP, Koliopoulos JX. Corneal complications following abuse of topical anesthetics. European Journal of Ophthalmology. 2002;12(5):373-378.
- Patel M, Fraunfelder FW. Toxicity of topical ophthalmic anesthetics. Expert Opinion on Drug Safety. 2013;12(1):95-103.
- British National Formulary (BNF). Local anaesthetics — Ophthalmic. National Institute for Health and Care Excellence. Available at: bnf.nice.org.uk
- Moreira LB, Kasetsuwan N, Sanchez D, et al. Toxicity of topical anesthetic agents to human keratocytes in vivo. Journal of Cataract & Refractive Surgery. 1999;25(7):975-980.
- Yagci A, Bozkurt B, Egrilmez S, et al. Topical anesthetic abuse keratopathy: a commonly overlooked health care problem. Cornea. 2011;30(5):571-575.
- Food and Drug Administration (FDA). Drug Safety Communication: Topical ophthalmic anesthetic products. FDA Drug Safety. Available at: www.fda.gov
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