Hyaluronidase injection approved by FDA

December 15, 2004

Rancho Cucamonga, CA-The drought may be over for ophthalmic surgeons who used Wydase, a hyaluronidase injection discontinued by its manufacturer in 2001, to speed the onset of anesthesia.

Rancho Cucamonga, CA-The drought may be over for ophthalmic surgeons who used Wydase, a hyaluronidase injection discontinued by its manufacturer in 2001, to speed the onset of anesthesia.

The FDA has approved a new hyaluronidase injection USP in 150 units/ml, in 1-ml vials, by Amphastar Pharmaceuticals Inc. that the company said has properties and side effects similar to Wydase. Amphastar has begun to ship Amphadase directly and through major drug wholesalers.

Hyaluronidase is an enzyme that breaks down hyaluronic acid in connective tissue, increasing tissue permeability. It is often used to facilitate the dispersion and absorption of other drugs, especially in nerve-block anesthesia and anesthesia before ophthalmic surgery.

Also, ISTA Pharmaceuticals Inc., Irvine, CA, announced Dec. 3 that the FDA has approved a single-use vial size of 200 USP units/ml of its hyaluronidase injection (Vitrase) ovine sterile solution for use as a spreading agent to facilitate the dispersion and absorption of other drugs. ISTA's product is a proprietary formulation of highly purified, preservative-free ovine hyaluronidase, which has been studied extensively in several ophthalmic conditions.

The company anticipates it will launch the new vial size, as well as the previously approved 6,200 USP units multi-purpose vial, early in the first quarter of 2005, said Vicente Anido Jr., PhD, ISTA's chief executive officer, in a prepared statement.

According to an American Academy of Ophthalmology roundtable discussion posted online, Wydase was used in about 750,000 procedures in 1999, and its withdrawal from the market sent "shock waves" throughout the ophthalmic community. Surgeons said they used it most often to reduce the amount of anesthesia required for cataract surgery.