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Lucentis preserves, improves vision for AMD patients, phase 3 study shows
Preliminary data suggests the drug may improve vision in 95% of study participants.
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SOUTH SAN FRANCISCO, Calif. – A drug in development for treatment of wet age-related macular degeneration maintained or improved vision in about 95% of patients after 1 year in a phase 3 clinical trial, according to the developer of the drug.
Preliminary analysis of data showed that approximately 95% of patients receiving Lucentis (ranibizumab, Genentech) maintained vision at 1 year, the primary endpoint in the trial, according to a press release from Genentech. For this study, maintenance of vision was defined as a loss of less than 15 letters in visual acuity. In the control arm of the study, in which patients received sham injections, 62% of patients maintained vision. The difference was statistically significant.
In addition, patients treated with Lucentis had, on average, a significant improvement in visual acuity compared to their visual acuity at study entry. This was a secondary endpoint in the study. Control patients had a decrease in visual acuity from baseline to 12 months.
Adverse events were similar to those seen in earlier trials of Lucentis, Genentech noted in the release. Common side effects that occurred more often in those dosed with Lucentis than in the sham group included conjunctival hemorrhage, eye pain and vitreous floaters.
‘Significant improvement’ seen
“These Lucentis data exceeded our expectations because they show, for the first time in a phase 3 trial, a statistically significant improvement in vision for patients in a disease that has remained chronic and progressive despite current treatment options,” said Hal Barron, MD, senior vice president, development and chief medical officer for Genentech.
The phase 3 study included 716 patients in the United States with minimally classic or occult wet AMD who were randomized two-to-one to receive intravitreal Lucentis injections or the sham control regimen. Patients in the Lucentis arm of the study were further randomized to receive either 0.3-mg or 0.5-mg doses of Lucentis once a month for 2 years.
“The news is incredibly exciting for my patients with AMD since we now have a treatment that may actually improve vision instead of just preventing vision loss,” said Peter K. Kaiser, MD, a retinal specialist at the Cole Eye Institute in Cleveland and an Ocular Surgery News Retina/Vitreous Editorial Board Member.
Dr. Kaiser told Ocular Surgery News the preliminary results did not surprise him, “since the phase 2 results have been robust and reproducible over several studies.” He said he looks forward to the full study results to be released in July at the American Society of Retina Specialists Annual Meeting in Montreal, Canada. However, he cautions that without seeing the full data set, comparisons to other drugs are premature.
Additional phase 3 trials
According to Genentech, two additional phase 3 trials on Lucentis are under way.
The Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization AMD, or ANCHOR, study is comparing two doses of Lucentis to photodynamic therapy in 423 patients. Genentech said in its press release that the results from this multicenter, international study are expected in the fourth quarter of 2005.
In another study, in 184 patients, dosing of Lucentis is once a month for the first three doses, and then once every 3 months for 2 years. Results of this trial are expected in the first half of 2006, the company said.
Dr. Kaiser expects additional data to be released in July that would allow physicians to compare this data to other drugs and randomized studies. Some of these additional findings include mean change in vision, percentage of patients with significant vision improvement, percentage of patients with severe vision loss, change in lesion size and composition, and complication rates.
Lucentis is being developed by Genentech and Novartis Ophthalmics. Genentech retains marketing rights to the drug in North America while Novartis has marketing rights for the rest of the world, the press release said.
Analysts expect the drug to reach the marketplace some time in 2007.
Genentech is partially owned by Roche Holdings, a Swiss-based pharmaceutical company.
For Your Information:
- Peter K. Kaiser, MD, can be reached at Division of Ophthalmology A31, Medical and Surgical Retina Unit at the Cole Eye Institute, 9500 Euclid Ave., Cleveland, OH 44195; 216-444-6702; fax: 216-445-2226; e-mail: pkkaiser@aol.com. Dr. Kaiser is a clinical investigator for the Cleveland Clinic, which receives research grant support from Genentech, Eyetech and Novartis. He is an unpaid member of the scientific advisory boards for Genentech and Novartis.
- Genentech, developer of Lucentis, can be reached at 1 DNA Way, South San Francisco, CA 94080-4990; 650-225-1000; fax: 650-225-6000; Web site: www.gene.com.
- Michelle Dalton is the Managing Editor of the OSN SuperSite. She writes daily updates on developments in all aspects of ophthalmology.