Eyetech confident about future of aptamers

New York-Eyetech Pharmaceuticals reassured investors in late June that pegaptanib sodium injection (Macugen), its drug for treatment of neovascular age-related macular degeneration (AMD), is a commercial success since its launch last January. The company revised its 2005 sales projections and expects the anti-VEGF aptamer to generate between $175 and $190 million-approximately $40 million more than earlier estimates.

The biotech company is pleased with its launch of pegaptanib sodium. CEO David R. Guyer, MD, noted that the drug is "on track for one of the top 10% of launches in the last 20 years of pharmaceuticals."

During Eyetech Vision Day, Dr. Guyer expressed his confidence in pegaptanib sodium, the first aptamer approved for human use in the treatment of AMD, and its potential expanded role in the treatment of other eye diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). He also wanted to share with investors the company's excitement about the future potential of other Eyetech products that are in development with its strategic partners, Pfizer Ophthalmics and Archemix Corp.

Eyetech Pharmaceuticals in early June adopted a "poison pill" shareholder rights' plan with a 15% trigger, to avoid the possibility of a hostile takeover.

"The shareholder rights' plan is an appropriate measure and was recommended to us by our board and outside counsel as a way at these low share prices to make sure that we maintain the ability of the board to respond appropriately to unwanted activity related to the stock price," explained Paul G. Chaney, chief operating officer, Eyetech Pharmaceuticals. "The shareholder rights' plan creates some protection that is in the best interest of stockholders. It means that it is in the control of the board.

"It is a signal that the company intends to maintain its independence and control if someone were to try to make a bid," Chaney explained. He had no comment when asked if anyone had tried to acquire Eyetech.

Back-of-eye diseases The potential worldwide market for treatment of back-of-the-eye diseases is promising, Dr. Guyer said. From 2005 to 2010, the commercial market of treatments for AMD is expected to expand from $2.8 to $5.8 billion. During that same period, the market for products for diabetic retinopathy and macular edema is projected to reach $4 billion. Eyetech Pharmaceuticals is focusing its efforts on meeting those needs with its pegaptanib sodium franchise.

As far as AMD treatments are concerned, Eyetech has a specific advantage being the pioneer in aptamer technology and the first one to bring a product to market, Dr. Guyer said. So far, pegaptanib sodium has shown to be safe and effective in preserving vision in patients with all types of neovascular AMD for 3 years.

"The drug, Macugen, has a remarkable safety profile," explained Donald J. D'Amico, MD, professor of ophthalmology, Harvard Medical School, Boston, and a consultant to Eyetech Pharmaceuticals, Alcon Laboratories, and Iridex. "To date, there has been no evidence of cataract formation or cataract acceleration with multiple doses and no evidence of changes in IOP. There have been some injection-related side effects, such as endophthalmitis, traumatic cataract, and retinal detachment. But these have been quite modifiable due to the improvements in our understanding of the injection protocol, including sterile technique."

Eyetech Pharmaceuticals plans to start phase II/III clinical trials of pegaptanib sodium for the treatment of DME in the second half of 2005. Phase II trials for the treatment of central RVO are in progress. There are no effective treatments for DME or RVO to date, Dr. Guyer said.