In-office compounded medication allows for immediate treatment of sight-threatening infections.

When a patient steps into your practice with a vision-threatening infection, you may have no time to waste.

Immediate treatment of serious eye infections, such as infectious corneal ulceration, is one of the major benefits of Harrow’s Fortisite (compounded tobramycin 1.5% plus vancomycin 5%). The availability of Fortisite for in-office use from Harrow’s ImprimisRx 503B outsourcing facility, announced in January 2023, represents the first time that ophthalmologists have been able to stock a fortified or high-concentration compounded antibiotic formulation for the immediate treatment of patients in need, according to the company.

Previously, physicians had to order Fortisite for delivery. Now, the medication can be kept on hand and stored in the office refrigerator.

FORTIFIED HELP

By definition, notes Eric D. Donnenfeld, MD, cornea, cataract and refractive surgeon, OCLI, Garden City, N.Y., fortified medications are stronger than commercially available medications. In the case of Fortisite, he notes, the tobramycin has a 1.5% concentration, compared with the 0.3% tobramycin that is FDA approved and commercially available.

What’s more, Dr. Donnenfeld points out, vancomycin, the second medication in Fortisite, is not available as an FDA-approved drop. Fortisite, he says, “is fortified and uses a medication that’s currently not FDA approved but has really been the standard of care for managing corneal ulcers for well over a decade.”

IMMEDIATE TREATMENT OF INFECTIONS

The major benefit of Fortisite is its immediate availability for patients suspected of having serious eye infections. Instead of sending a patient to a compounding pharmacy, a physician can store the medication in a refrigerator and dispense it as soon as needed.

Prior to Fortisite, physicians had two options for using antibiotics for patients with corneal ulcers, according to Brian M. Shafer, MD, adjunct assistant professor of ophthalmology, Perelman School of Medicine, University of Pennsylvania. The first was using commercially available FDA-approved antibiotics, such as moxifloxacin and ofloxacin. Unfortunately, he notes, some corneal ulcers have been recalcitrant to treatment with commercially available antibiotics.

The second option was to use fortified antibiotics from a compounding pharmacy. “This has been one of the biggest issues for treating corneal ulcers, because if a patient doesn’t have access to a compounding pharmacy in their vicinity, they have to travel — many of them for hours — to get the medication they need,” says Dr. Shafer. “That’s where Fortisite has come in and really changed the game. Now there’s no longer a lag time, nor is there a drive that the patient has to make to get the antibiotic.”

Dr. Donnenfeld agrees. “When it comes to an infectious keratitis that is vision threatening, time is of the essence because even a few hours can result in the infection spreading into the visual axis and causing permanent loss of vision. Having access to the best broad-spectrum therapy against infectious keratitis gives me a sense of security that I’ll always be ready for that worst-case scenario when a patient does come in with an infection and I want to treat it immediately.”

TWO AT ONCE

Because the medication comes in one bottle, the patient instills both medications at the same time, notes Dr. Donnenfeld. Before Fortisite, tobramycin was in one bottle and vancomycin in another. Patients instilled one drop, then waited an hour to instill the second drop. “Now they’re getting both medications every time they put a drop in their eye. They’re getting basically twice as much drug delivered to the eye as they were previously, Dr. Donnenfeld says.

“SHOTGUN THERAPY”

In general, notes Dr. Shafer, patients who need fortified antibiotics compared to commercially available antibiotics are those who have a corneal ulcer that is in central vision, or greater than 1 mm, or unresponsive to commercially available products. Any of those types of ulcers in those three categories have the potential to progress rapidly, he explains, which could lead to corneal perforation and blindness.

First-line treatment for infectious keratitis, typically involves “shotgun therapy” — that is, using a therapy that covers both gram-negative and gram-positive bacteria, says Dr. Donnenfeld. “There is no medication that really covers all these different infections, which is why a combination medication that has a great gram-negative coverage and a great gram-positive coverage is ideal for managing infectious keratitis.”

The organism that’s most commonly responsible today for infectious keratitis in many settings is methicillin resistant staphylococcus aureus (MRSA), says Dr. Donnenfeld, and commercially available antibiotics often have limited activity against these bacteria. The medication with the best activity against MRSA is vancomycin, he says, and that’s why vancomycin is used to manage these corneal ulcers. Of course, physicians would not use Fortisite for fungal keratitis, Dr. Shafer notes.

Because Fortisite contains very high concentration medications, it is potent, so patients might experience some adverse effects.

“Just as our compounded fortified antibiotics are very toxic to the ocular surface, we see the same thing with Fortisite in that it’s a medication that is very powerful and therefore is quite a bit caustic to the ocular surface,” says Dr. Shafer. “The most common thing that patients complain about is redness, irritation and burning with instillation of the drop. All of that is the same with the fortified antibiotics that we would get from compounding pharmacies.”

Due to Fortisite’s very high concentration medications, Dr. Donnenfeld says “there is a little bit more burning than in a conventional medication.”

REPLACEMENT GUARANTEE

Harrow says Fortisite is stable at refrigerated temperatures (5°C) for up to 180 days. The company offers a 100% replacement guarantee for any expired 503B Fortisite product, ensuring that physicians can stock Fortisite continuously in their offices without the expense of replacing an expired medication.

Dr. Shafer says he stocks three bottles at a time. As for Dr. Donnenfeld’s practice, “We have two bottles on hand in our office at all times,” he says.

Harrow offers same-day shipping to patients if the prescription is received by 3 p.m. EST and it is shipped cold overnight at no additional cost. No minimum order is required.

“Fortisite solves one of the great unmet needs I have in my practice and allows me to be a better clinician taking care of patients more safely and efficaciously that I’ve ever been able to do previously,” concludes Dr. Donnenfeld. OM