The U.S. Food and Drug Administration has given the pre-market approval to Advanced Medical Optics, Inc.’s Healon D®. To be used as a surgical aid in procedures such as corneal transplant, cataract extraction, glaucoma filtration and implantation of intraocular lens (IOL), the ophthalmic visco-surgical device (OVD) offers incomparable clarity in the field of surgery and protects corneal cells well. Its molecular weight being low, Healon D® stays in place for the entire process of surgery. It ensures safer environment for doctors and patients as it is latex free.

The U.S. Food and Drug Administration has given 510(k) clearance to the company’s SOLX 790 for use in Titanium: Sapphire laser trabeculoplasty (TLT). The clearance followed the results of a multi-center clinical trial which established the equivalence of TLT to ALT in its ability to reduce intraocular pressure (IOP) in patients suffering from primary open angle glaucoma and poorly controlled IOP. The laser emits pulses of energy at a wavelength of 790 nm that loosens particles in the trabecular meshwork. The penetration of this energy into the tissue is deeper than other currently used trabeculoplasty lasers. The treatment is long-lasting and less damaging.

SynergEyes Inc. has recently launched a revolutionary hybrid contact lens designed for people who need further vision correction after undergoing refractive vision surgery, such as LASIK. SynergEyes(R) PS (post-surgical) is also designed for patients who have experienced some type of corneal trauma or suffer from certain degenerative vision conditions. Approved for marketing by the FDA, SynergEyes PS hybrid contact lenses bond a “hard” and “soft” contact lens together resulting in a one-of-a-kind vision correction option that provides crisp, clear vision for surgically altered corneas in a comfortable, healthy contact lens.

Hi-Tech Pharmacal Co Inc has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution. Hi-Tech Pharmacal’s dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic version of Merck’s Cosopt, for the treatment of glaucoma. The company said that it has 180 days of marketing exclusivity for generic dorzolamide hydrochloride with timolol maleate ophthalmic solution, and will begin marketing the product upon the completion of Merck’s pediatric exclusivity period in October 2008.