Jane S. Ricciuti, RPh, MS

Disclosures

January 20, 2005

In This Article

Ophthalmic Agents

Macugen
(pegaptinib) Injection

Manufacturer: Eyetech Pharmaceuticals, Inc.

Drug Approval Classification: Original New Drug Application (Approval Date: 12/17/04)

Indication: Macugen (pegaptinib) injection is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Dosing: Pegaptinib 0.3 mg should be administered once every 6 weeks by intravitreous injection into the eye to be treated (see product labeling for additional detailed information).

Clinical Summary: Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist. VEGF is a secreted protein that selectively binds and activates its receptors located primarily on the surface of vascular endothelial cells. VEGF induces angiogenesis and increases vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD, a leading cause of blindness.

Pegaptinib was studied in 2 controlled, double-masked, and identically designed randomized studies in patients with neovascular AMD. Patients were randomized to receive control (sham treatment) or 0.3 mg, 1 mg, or 3 mg pegaptinib administered as intravitreous injections every 6 weeks for 48 weeks. A total of approximately 1200 patients were enrolled with 892 patients receiving pegaptinib and 298 receiving a sham injection. Patients received a mean 8.5 treatments out of a possible 9 total treatments across all treatment arms. The primary efficacy endpoint was the proportion of patients losing less than 15 letters of visual acuity, from baseline up to 54-week assessment.

The groups treated with pegaptinib 0.3 mg exhibited a statistically significant result in both trials for the primary efficacy endpoint at 1 year: Study 1, pegaptinib 73% vs Sham 60%; Study 2, pegaptinib 67% vs Sham 53%.

Adverse Effects: Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. The most frequently reported adverse events in patients treated with pegaptinib 0.3 mg for up to 2 years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10% to 40% of patients.

Pharmacokinetics: Pegaptinib mean maximum plasma concentration is about 80 ng/mL, and it occurs within 1 to 4 days after a 3-mg monocular dose (10 times the recommended dose). The mean area under the plasma concentration-time curve (AUC) is about 25 mcg·hr/mL at this dose. Based on preclinical data, pegaptanib is metabolized by endo- and exonucleases. In humans, after a 3-mg monocular dose (10 times the recommended dose), the average apparent plasma half-life of pegaptanib is 10 ± 4 days.

Macugen (pegaptinib) Injection Letter

Vision Blue
(trypan blue) Ophthalmic Solution

Manufacturer: D.O.R.C. International

Drug Approval Classification: Original New Drug Application (Approval Date: 12/16/04)

Indication: Vision Blue (trypan blue) ophthalmic solution is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens.

Dosing: Vision Blue is for use during cataract surgery and is packaged in a 2.25-mL syringe to which a blunt cannula has to be attached. After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of Vision Blue by the aqueous. Sufficient staining is achieved as soon as the dye has contacted the capsule.

Clinical Summary: Vision Blue is a 0.06% sterile solution of trypan blue (an acid di-azo group dye). Vision Blue is a selective tissue staining agent for use as a medical aid in ophthalmic surgery. Vision Blue is intended to be applied directly on the anterior lens capsule, staining any portion of the capsule which comes in contact with the dye.

Vision Blue (trypan blue) Ophthalmic Solution Label

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