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Quarterly dosing with ranibizumab may not be ideal
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SOUTH SAN FRANCISCO, Calif. — Quarterly dosing with intravitreal ranibizumab for the treatment of age-related macular degeneration may not be optimal, according to results from a phase 3b study.
Genentech executives discussed the results of the Lucentis (ranibizumab) PIER study late last week. The phase 3b trial enrolled 184 patients with predominantly classic, minimally classic or occult with no-classic wet AMD. Patients were randomized to receive either Lucentis 0.3 mg, Lucentis 0.5 mg or control injections (control group) once a month for the first 3 months, then once every 3 months for a total of 24 months.
“Patients treated with Lucentis, on average, demonstrated an initial increase in mean visual acuity compared to baseline after 3 monthly injections,” Genentech officials said in a release. At month 3, the 0.3 mg group showed an increase of 2.9 lines, and the 0.5 mg group showed an increase of 4.3 letters. The control group, by contrast, lost an average of 8.7 letters in the same time period.
On average, after the follow-up injections at months 6, 9 and 12, patients returned to baseline visual acuity, while patients in the control group experienced “significant visual loss,” Genentech said.
The PIER data “suggest that treating patients on a quarterly basis may be less effective than monthly or individualized dosing,” said Hal Barron, MD, senior vice president of development and chief medical officer at Genentech. In previous studies, patients dosed monthly have shown an average 11 letter gain.
As with previous Lucentis studies, side effects that occurred more frequently in the Lucentis groups than in the control groups included conjunctival hemorrhage, eye pain and increased IOP. There were no reported cases of endophthalmitis, serious intraocular inflammation or other key ocular serious adverse events. There were no deaths, myocardial infarctions or cerebral vascular events in the first year of the study.
Lucentis has been filed with the Food and Drug Administration, and will be ruled upon by June 30, Ian Clark, Genentech executive vice president, commercial operations, said in a Web cast. Mr. Clark said he expects the company to begin shipping the drug to retinal specialists within 48 hours of approval. He predicted about 87% of the eligible patient population will be on Medicare, and that ophthalmologists would be able to use the miscellaneous code to be reimbursed from the Centers for Medicare and Medicaid Services, he said.