Macugen 2-year safety data favorable in exudative AMD

The 2-year safety profile of pegaptanib is “favorable” in patients with exudative age-related macular degeneration, according to a study.

Members of the VEGF Inhibition Study in Ocular Neovascularization (VISION) Clinical Trial Group analyzed data from two concurrent, prospective, randomized, multicenter, double-masked, sham-controlled studies comparing three intravitreous doses of Macugen (pegaptanib, Pfizer/OSI).

Patients were randomized to receive 0.3 mg (295 patients), 1 mg (301 patients), 3 mg (296 patients) of Macugen or sham injections (298 patients) every 6 weeks for 54 weeks. After the first year, patients were re-randomized for a second year to either discontinue therapy or to continue therapy with the same dose as in the first year. In the second year, 425 patients continued with the same dose; a total of 2,663 injections were administered to this patient group.

All doses were well tolerated, with the most common ocular adverse events being transient, mild to moderate in intensity and attributed to the injection preparation and procedure, the authors said.

In year 1, serious injection-related complications included endophthalmitis, retinal detachment and traumatic cataract. The authors note most endophthalmitis cases followed violations of the injection preparation protocol. In the patients who had 2-year follow up, there were no reports of endophthalmitis or traumatic cataract. Rhegmatogenous retinal detachment was reported in four patients.

“Given the lack of ocular inflammatory response generated by intravitreous pegaptanib sodium, selective blockade of the most pathologically driven isoform of VEGF, and absence of evidence to suggest drug-related thromboembolic events in these pivotal trials, the 2-year safety profile of pegaptanib sodium remains compelling,” they said.

The study is published in the June issue of Ophthalmology.