Alice Rinaldi and Mary Lu Ruckman have two things in common.

Both were losing their sight to a condition that affects close to 2 million Americans every year. And the sight of both has been restored, with a drug tested by a Palm Beach Gardens ophthalmologist that recently received Food and Drug Administration approval.

The drug, Lucentis, treats wet, age-related macular degeneration, or AMD, the leading cause of blindness in those 60 and older.

The disease blurs the sharp central vision and affects the part of the eye needed to see fine detail. Blood vessels behind the retina leak blood and fluid, making vision worse.

Two years ago Rinaldi, 76, of Hobe Sound noticed something alarming. When she tried to read, the center parts of words were disappearing. A trip to retina specialists Mark Michels and Adrian Lavina in Palm Beach Gardens confirmed she suffered from the condition.

It took a little persuasion, but Rinaldi agreed to participate in a clinical trial using Lucentis. It essentially saved her sight.

"I asked what were the consequences if I didn't do it. He said it would be blindness," Rinaldi said.

Within two months of the first injections, Rinaldi noticed marked improvement.

"I have not one regret. The drug is a miracle," she said.

Lucentis is made by Genentech of San Francisco. Injected into the eye, it inhibits the formation and leakage of new blood vessels in the back of the eye, the primary cause of central vision loss associated with wet macular degeneration. It's being touted as one of the most important developments in ophthalmology because of its potential not only to stop but also to reverse vision loss associated with wet AMD.

"It's probably the highlight of my career," said Michels, who has been among a group of retina specialists around the country who participated in the clinical trials that led to the FDA approval on June 30.

Michels' practice treated about 150 patients during the clinical trials. Since the FDA approval, he added another 25. He also is co-writing an article about the drug for The New England Journal of Medicine.

The odds of developing wet macular degeneration increase with age. The rate is about 18 percent among those 70 to 74, but shoots up to 47 percent among those 85 and older.

Ruckman, 85, also of Hobe Sound was diagnosed last year with AMD. Like Rinaldi, she noticed a "black hole" in her vision. Michels first put her on another drug, Macugen, an FDA-approved drug also injected into the eye. However, although it's been shown to slow progression of the disease, it reverses it in only a small percentage of patients. After four treatments, Ruckman didn't appear to be getting better, so Michels switched her to Lucentis.

"The first treatment was absolutely magnificent. I could see and the black spot was gone," she said.

The current regimen is to treat a patient monthly for three months, then observe to see whether additional treatments are required. Michels said that in some cases, patients can go a few months without another injection. Genentech estimates that the average number of Lucentis injections is expected to range from five to seven a year. Michels equates them with "booster" shots.

In clinical trials, 95 percent of patients on Lucentis at least maintained their vision in the treated eye, and it improved for as many as 40 percent. The drug works better on those whose condition is caught early.

The most common side effects include eye pain, intraocular pressure, inflammation and "floaters" - specks that float about in the field of vision.

Other drugs offer some help for AMD sufferers. Avastin, which the FDA has approved for treatment of colorectal cancer, also is being used "off-label" to treat AMD. The FDA permits doctors to use drugs off-label for conditions other than for what they are approved.

Avastin also is made by Genentech but is significantly less expensive. The company has said it does not support this off-label use and has no plans to conduct clinical trials to study Avastin use in the eye.

Cost of injection: $1,950

Although Michels is thrilled that the drug has received the FDA's blessing, he's "frustrated" by its $1,950-per-injection price tag - compared with $995 for Macugen and about $50 per dose for Avastin.

A Genentech spokeswoman said the company hopes to ensure that no one goes without the drug because he can't afford it.

"We put nearly a decade of study into Lucentis, so our job is to make sure we can help provide access for patients to Lucentis and make sure cost is not a barrier," Dawn Kalmar said.

Medicare patients with supplemental insurance will pay $50 or less out of pocket, she said. For those who have a high co-payment or no supplemental insurance, Genentech will refer them to independent charities to help defray the cost. And for those who have no insurance or who are denied coverage, Genentech has an "Access to Care" foundation, which last year provided $200 million in free drugs to 18,000 patients.

susan_miller@pbpost.com