Visx maneuvers to defend itself against possible takeover
HCFA set to issue new carrier memorandum on Visudyne coverage
Ciba's glaucoma drug approved
Hospitals facing regulatory, payment burdens
Legislators head home
FDA releases draft guidelines for refractive implants
Briefs

Visx maneuvers to defend itself against possible takeover

Visx Inc. reported that Carl Icahn, the financier famous for his 1986 takeover of Trans World Airlines and a takeover attempt on Nabisco Group Holdings Corp. earlier this year, filed to buy more than $15 million worth of its stock. While the amount represents less than 15% of shares of Visx stock outstanding, the action prompted the company to adopt what the Wall Street Journal characterized as a “poison-pill plan,” a strategic move in which a company targeted for takeover makes its stock less attractive to a prospective purchaser.
After a special meeting called to address Icahn’s letter, Visx’s board of directors unanimously approved a “shareholder’s rights plan,” in which holders can exercise their rights if a person or a group acquires 10% or more of the company’s common stock. Rights will be distributed as a dividend at the rate of one right for each share of common stock, par value $0.01 per share, of the company held by stockholders of record as of the close of business on Aug. 7. Each right entitles holders to buy one share of Visx for $150. According to a WSJ report, the company’s stock fell $1.25, or 5.4%, to $22 in 4 p.m. Nasdaq stock market trading on July 28, but rose $1.50 to $23.50 per share in after-hours trading. A government filing indicated that Visx had 60.7 million shares outstanding as of April 30.

HCFA set to issue new carrier memorandum on Visudyne coverage

With the recent approval of Visudyne’s (verteporfin for injection, CIBA and QLT Inc.) inclusion on the U.S. Pharmacopoeia, Medicare will issue a clarifying memorandum to its carriers. At present, physicians performing the procedure in the office should bill for ocular photodynamic therapy using the unlisted procedure code 67299, which will include the infusion. The supply of verteporfin should be billed separately using J3490 until further notice.

Ciba's glaucoma drug approved

Ciba Vision's glaucoma drug Rescula (unoprostone isopropyl ophthalmic solution) 0.15% won marketing approval from the Food and Drug Administration on Thursday. The drug is a new synthetic docosanoid compound, indicated for the treatmentof open-angle glaucoma or ocular hypertension. According to Ciba, Rescula is unique among glaucoma medications in that it is the only ocular therap containing a docosanoid, a lipid with 22-carbon atoms derived from docosahexaenoic acid. Ciba also claimed that Rescula consistently and safely lowers intraocular pressure when used as a monotherapy or in combination with other drugs, and that it lowers IOP without affecting cardiovascular or pulmonary functions.

Hospitals facing regulatory, payment burdens

Two recent federal actions have hospitals crying foul. The FDA announced last week that hospitals have a year to stop reprocessing “single-use” medical devices or file for 510(k) approval for the reprocessed items. Ophthalmic single-use items commonly sterilized and reused by hospitals or third-party reprocessors include keratome blades, surgical drapes, and phaco needles. So far, it appears that the rules will not apply to ambulatory surgery centers. More information is available at www.fda.gov/cdrh/reuse/reuse-documents.shtml. Hospitals are also facing the implementation of a new Ambulatory Payment Classification (APC) system, which began Aug. 1. Some hospitals claim their reimbursements will drop dramatically under the APCs, which are part of the move to a prospective payment system for outpatient care.

Legislators head home

Legislators headed back to their home districts for the August recess. When they return to Washington, time will be short for action on two key measures. The first of these is passage of a strong patient’s bill of rights, which has been stalled in conference committee over partisan differences. The second legislative priority for ophthalmology is to get physician practice expense changes incorporated in a bill designed to give some funding back to Medicare providers. Ophthalmologists will receive a Grassroots Alert with further information about how to contact their representatives this month to urge their support for these priorities.

FDA releases draft guidelines for refractive implants

BRIEFS: Georgia Brown, practice administrator for Everett & Hurite Ophthalmic in Pittsburgh, was featured in the Pittsburgh Post-Gazette for her participation in the Patient Access Coalition’s grassroots campaign in Pa., Mich., and Mo. to convince Congress to approve a patient’s bill of rights this year. ... The European Union Commission has given Ciba Vision approval to market Visudyne for the treatment of the wet form of age-related macular degeneration, Novartis, Ciba’s parent company, announced last week. … Staar Surgical Co. announced that it submitted a request to the FDA to begin manufacturing its one-piece Collamer intraocular lens at its Monrovia, Calif., headquarters. The request was prompted by the strong sales the Collamer has shown since it received FDA approval in April. ... QLT reported that its sales of Visudyne in the United States beat analysts expectations by 60%, with sales of $25.5 million (Canadian). The company also reported $14.5 million in net income for the second quarter, up from $6.1 million in the comparable year-ago quarter. … KeraVision Inc.’s second-quarter net loss was 57 cents a share, compared with 45 cents a share in the year-ago quarter. The company attributes the size of the loss to investments in professional and consumer market-development activities in the United States. … Sight Resource announced second-quarter net losses of 8 cents a diluted share ($695,000) on revenues of $16.5 million, compared with income of 3 cents a diluted share in the year-ago quarter. Sight Resources is appealing a Nasdaq ruling that notified the company that it no longer meets the asset requirements for continued listing on the national market. Coherent Inc.’s third-quarter net income was 36 cents per share ($9.9 million), up 45% from year-ago pro forma results. Sales increased 30% during the same period. … SurgiLight Inc.’s second-quarter net income was $39,000, compared with a $27,000 net loss in the first quarter. Six-month net income was $0.001 per share ($12,000) compared with 1 cent per share in the year-ago period. … Akorn announced second-quarter net income of $2.2 million, up 30% from the year-ago quarter. Revenue, at $18.3 million, is up 14%; research and development expenses increased 56%. ... The FDA has approved Lacrimedics’ 510(k) application for the Opaque Herrick lacrimal plug, which should be available this month.