Evaluation of a topical anesthetic gel reduces patient discomfort after intravitreal injections

A press release issued by Harrow, Inc. announced positive results from a prospective, randomized, contralateral-eye study that evaluated IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% in patients undergoing same-day bilateral intravitreal injections.

Patients reported approximately 58% less discomfort overall in the eyes treated with IHEEZO compared with the fellow eye treated with proparacaine ophthalmic solution 0.5%, a difference that reached significance at four assessments conducted after the injections.

Millions of intravitreal injections are administered in the US annually making them among the most frequently performed procedures in ophthalmology. Patients with retinal diseases often undergo these repeatedly over months or years making the injection experience including patient discomfort an important consideration for patients and retina specialists, the press release mentioned.

About the ophthalmic gel

Chloroprocaine hydrochloride ophthalmic gel 3% is described as an ester anesthetic intended for topical ophthalmic use and indicated to induce ocular surface anesthesia. The drug is administered by a healthcare provider and is not injected or administered intraocularly.

The ophthalmic gel carries the risks of corneal injury due to insensitivity and corneal opacification. The most common adverse reaction is mydriasis in approximately 25% of patients, the press release described.

About the study

The investigators conducted a single-center, prospective, randomized, contralateral-eye comparison in a private retina practice. The study evaluated 100 eyes of 50 adult patients who were undergoing same-day bilateral intravitreal injections. Both eyes of all patients received 2% lidocaine-soaked pledgets before the study drug was administered.

One randomly assigned eye of each patient was treated with IHEEZO before the injection, and the fellow eye received preservative-containing proparacaine ophthalmic solution 0.5%. This design allowed each patient to serve as his or her own control and reduced between-patient variability. Patient-reported ocular discomfort was assessed using a 0-to-10 numeric rating scale at 2 minutes and 1, 6 to 12, and 24 hours after injection, the investigators explained.

Patient-reported pain levels

The study identified significant (P ≤ 0.048 for all comparisons) differences favoring IHEEZO at each assessment, with an approximate difference of 58% less discomfort overall in the eye treated with the drug under study compared with the fellow eye treated with proparacaine ophthalmic solution 0.5%. The greatest treatment differences between the two drugs were found immediately after injection, the point at which discomfort is the highest. At 2 minutes, the discomfort scores were 1.44 vs 3.06, for a difference of 1.62 points and at 1 hour 1.26 vs 2.82, a difference of 1.56 points. Lower discomfort scores associated with IHEEZO were recorded throughout the 24-hour assessment.

Principal Investigator Travis Peck, MD, of Retina Consultants of Delmarva, Salisbury, MD, commented, "Patient comfort is a larger part of the intravitreal injection experience than it is sometimes given credit for. In this study, because each patient received both anesthetic approaches on the same day, we were able to directly compare the patient experience. Patients consistently reported less discomfort in the IHEEZO-treated eye across all time points. For retina specialists who perform a high volume of injections and care for patients who return repeatedly for treatment, these are practical and clinically relevant findings."

Mark L. Baum, Harrow’s Chief Executive Officer, stated, “The results provide new clinical evidence from a real-world practice setting supporting IHEEZO's differentiated clinical profile versus commonly administered legacy ophthalmic anesthesia modalities and demonstrate a measurable improvement in patient-reported comfort following intravitreal injections. Retina specialists work to preserve vision in patients who require ongoing treatment over many years, and the experience of each of those visits matters and ideally, should be optimized.”