General Information

Viroptic Ophthalmic Solution, 1% Sterile (trifluridine ophthalmic solution) is an antiviral drug.

Viroptic is specifically indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.

Viroptic is supplied as a solution. Instill one drop of Viroptic Ophthalmic Solution, 1% onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of nine drops until the corneal ulcer has completely re-epithelialized. Following re-epithelialization, treatment for an additional 7 days of one drop every 4 hours while awake for a minimum daily dosage of five drops is recommended.

If there are no signs of improvement after 7 days of therapy or complete reepithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of Viroptic for periods exceeding 21 days should be avoided because of potential ocular toxicity.

Mechanism of Action

Trifluridine is a fluorinated pyrimidine nucleoside with in vitro and in vivo activity against herpes simplex virus, types 1 and 2 and vacciniavirus. Some strains of adenovirus are also inhibited in vitro. Trifluridine interferes with DNA synthesis in cultured mammalian cells. However, its antiviral mechanism of action is not completely known.

Side Effects

Adverse effects associated with the use of Viroptic may include, but are not limited to, the following:

• mild, transient burning or stinging upon instillation
• palpebral edema
• superficial punctate keratopathy
• epithelial keratopathy
• hypersensitivity reaction
• stromal edema
• irritation
• keratitis sicca
• hyperemia
• increased intraocular pressure

Clinical Trial Results

During a controlled multicenter clinical trial, 92 of 97 (95%) patients (78 of 81 with dendritic and 14 of 16 with geographic ulcers) responded to therapy with Viroptic as evidenced by complete corneal re-epithelialization within the 14-day therapy period. Fifty-six of 75 (75%) patients (49 of 58 with dendritic and 7 of 17 with geographic ulcers) responded to idoxuridine therapy. The mean time to corneal re-epithelialization for dendritic ulcers (6 days) and geographic ulcers (7 days) was similar for both therapies.

In other clinical studies, Viroptic was evaluated in the treatment of herpes simplex virus keratitis in patients who were unresponsive or intolerant to the topical administration of idoxuridine or vidarabine. Viroptic was effective in 138 of 150 (92%) patients (109 of 114 with dendritic and 29 of 36 with geographic ulcers) as evidenced by corneal re-epithelialization. The mean time to corneal re-epithelialization was 6 days for patients with dendritic ulcers and 12 days for patients with geographic ulcers. The clinical efficacy of Viroptic in the treatment of stromal keratitis and uveitis due to herpes simplex virus or ophthalmic infections caused by vacciniavirus and adenovirus has not been established by well-controlled clinical trials. Viroptic has not been shown to be effective in the prophylaxis of herpes simplex virus keratoconjunctivitis and epithelial keratitis by well-controlled clinical trials. Viroptic is not effective against bacterial, fungal, or chlamydial infections of the cornea or nonviral trophic lesions.