FDA Approves Genentech Drug For Eye Disease

The Food and Drug Administration approved a drug Friday that's been shown to improve vision in patients with a type of age-related macular degeneration that causes blindness.
The drug Lucentis, by Genentech Inc. (DNA), South San Francisco, Calif., is the first FDA-approved treatment that's been shown to stabilize vision in the vast majority of people with so-called wet AMD and improve it in many others. Genentech is majority-owned by Roche Holding AG (RHHBY) of Switzerland. Swiss-based Novartis AG (NVS) was also involved in the development of Lucentis.

The drug was approved under the FDA's priority review mechanism, which cuts about four months off the typical 10-month drug review time and is usually reserved for drugs the agency deems would be a "significant improvement" compared with existing treatments.

Genentech said it would begin shipping the product Friday.
"Lucentis provides new hope for patients with wet AMD because it is the first therapy to provide a benefit in vision for a significant number of patients," Genentech Chief Executive Arthur Levinson said in a press release.

About 15 million Americans have age-related macular degeneration, and roughly 10% of those suffer from the so-called wet form of AMD, which causes most cases of blindness from AMD. Wet AMD occurs when abnormal blood vessel growth harms or destroys part of the eye.

Lucentis, which is a variation of Genentech's cancer drug Avastin, is designed to inhibit a protein needed in blood vessel formation. It would be injected into the eyes every month.
Lucentis, however, is generating controversy among eye doctors because some of them had already started using Avastin to treat wet AMD at a fraction of the cost of cancer treatment because less drug is needed. At least one local Medicare plan decided last month to pay for use of Avastin in the eye even though the drug is not FDA approved for that use. Genentech has not promoted Avastin as an eye treatment and has been focused on developing Lucentis.

In late 2004, the FDA approved a drug, Macugen, developed by OSI Pharmaceuticals Inc. (OSIP) and Pfizer Inc. (PFE), which was shown to slow vision loss. Wiley Chambers, FDA's deputy director of its anti-infectives and opthamologic products division, said Macugen and another wet AMD treatment, Visudyne, marketed by Novartis and QLT Inc. (QLTI), have shown "variable results" in patients and improve vision in about 5% to 10% of people using the drugs. Clinical studies of Lucentis showed the drug improved vision in about one-third of patients in the clinical trials, Chambers explained.
Friedman Billings Ramsey analyst Jim Reddoch predicts Lucentis sales of $84 million this year, rising to $457 million in 2008. In comparison, Genentech's Avastin sales were $1.1 billion in 2005.

The company expects Lucentis to cost $1,950 per dose, and the average patient would receive five to seven doses per year, for total annual costs of $9,750 to $13,650, according to Quinton C. Oswald, Genentech's vice president sales and marketing, tissue growth and repair.

While its recommended that Lucentis be injected monthly, FDA's Chambers said some patients might be injected on a less frequent basis.

The drug was involved in two Phase III studies that looked at about 1,100 patients. The studies compared Lucentis to either a sham injection or Visudyne. Genentech said that 95% of people taking Lucentis maintained their vision after one year, and up to 40% had vision improvement, defined as being able to read three more lines, or 15 letters, on eye charts.
The studies of Lucentis showed the most common adverse reactions among patients treated with Lucentis included conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure and intraocular inflammation.
Genentech expects to get Medicare coverage for Lucentis "immediately." The company will contribute to programs designed to assist patients who can't afford Lucentis.
Shares of Genentech closed Friday at $81.80, up $1.67, or 2.1%.