at press time

ThinOptX Seeking New Funding
Clinical Trial for Ultra-Thin IOL Halted.

ThinOptX, which recently began a U.S. clinical trial for its ultra-thin ThinLens IOL that can be implanted through a 1.5-mm microincision, has run short of cash and is seeking either venture capital funding or a partnership with a financially strong eyecare company. The Virginia-based company has put the clinical trial on hold until funding is forthcoming.

"This is something we ran into because of slow summer sales in Europe, where the ThinOptX lens has been approved since 2002," ThinOptX President and CEO Wayne Callahan recently told Ophthalmology Management. "We're currently in discussions with six to eight venture capital groups. We will find the money we're seeking."

ThinOptX's current financial problems came to light when a former company executive sent out a number of e-mails to people in the eyecare industry announcing his availability for new employment opportunities. The e-mail went into some detail about the ThinOptX financial situation.

"That e-mail was unfortunate," says Callahan. "I've been in this business for 27 years and have a track record of two previous successful IOL startups. I've been around long enough to expect some peaks and valleys when you're starting a new company. This is obviously a valley. But we have a great product that's been praised by many leading cataract surgeons. We had some excellent papers at the recent ESCRS meeting and we're also expecting approval to market the lens in Australia very soon, so there's plenty of good news that's going to benefit ThinOptX in the future."

Callahan said FDA approval of the hydrophilic acrylic ThinOptX lens should take about 2 years once the clinical trial resumes, but that finding new funding shouldn't be difficult because ThinOptX has approximately 20 patents relating to manufacturing innovation and the development of thin IOLs.

"We're open to partnerships, licensing deals or venture capital," says Callahan. "However, all of these types of deals involve negotiations, and we don't want to give too much of the company away just to solve a problem that we believe is temporary."

2004 PAT Survey Shows Wider Use of ISI
Steroids Gain Acceptance in Wet AMD and DME.

U.S. retina specialists have almost universally adopted photodynamic therapy (PDT) as their treatment of preference for wet AMD, and many have recently begun to combine injections of intravitreal steroids with PDT therapy to produce a greater patient benefit.

These are two of the key findings of the 2004 American Society of Retina Specialists (ASRS) Preferences and Trends Survey, which is often referred to as the PAT Survey.

"PDT with Visudyne has clearly established itself as the leading treatment for wet AMD over the last 4 years, but intravitreal steroid injections (ISI) are once again the headline stealers this year, as they seem to be used with ever-increasing frequency for a variety of disorders," says John S. Pollack, M.D., assistant professor of Ophthalmology at Rush Medical College in Chicago and a partner with Illinois Retina Associates, S.C. Dr.Pollack serves as editor of the ASRS PAT Survey, along with co-editor Kirk H. Packo, M.D.

Dr. Pollack notes that reports last year from Richard Spaide, M.D., and others suggest that combining PDT with ISI may provide greater benefit than PDT alone. This technique was adopted very quickly by retina specialists, with 59% of PAT Survey respondents reporting using the technique in 2004, as compared to only 21% a year earlier.

Since 2001 the PAT Survey has also asked its membership how they manage diabetic macular edema (DME) that's unresponsive to maximal laser treatment. The Survey shows a rapid increase in popularity in ISI over the last 3 years.

"Despite the absence of completed large, prospective, randomized clinical trials, numerous small studies have presented compelling evidence that this treatment may represent a reasonably safe and effective option for patients who have no other proven options left for management of refractory macular edema," says Dr. Pollack.

FDA Grants Three New Approvals
Macugen OK'd for All AMD Lesion Subtypes and Sizes.

The FDA was in a giving mood just prior to Christmas as it approved a high-profile treatment for wet AMD, wavefront-guided laser surgery for hyperopia and astigmatism, and a combination drug for steroid-responsive inflammatory ocular conditions.

The most widely awaited approval was given to pegaptanib sodium injection (Macugen), an Eyetech/Pfizer drug delivered intravitreally. Approval was based on two pivotal Phase II/III studies in which 70% of treated patients lost less than three lines of vision after 54 weeks.

Macugen targets vascular endothelial growth factor (VEGF), a protein that acts as a signal in triggering the abnormal blood vessel growth and leakage that is the hallmark of neovascular AMD.

"Macugen is a novel treatment based on elegant science that for the first time targets the underlying cause of the disease, which has led to our broad AMD label, including all subtypes and sizes," said David R. Guyer, M.D., CEO and co-founder of Eyetech Pharmaceuticals.

Additionally, VISX, Inc. received approval to treat hyperopia and astigmatism with the CustomVue wavefront-guided laser vision correction procedure. The approval covers procedures up to +3D MRSE, with cylinder up to +2D, however VISX says surgeons will have the discretion to treat up to +5D MRSE.

The CustomVue procedure is the first wavefront-guided laser treatment for hyperopia to be approved in the United States and employs the VISX WaveScan System.

Also approved was Bausch & Lomb's novel combination product, loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension (Zylet). Zylet is indicated for the treatment of inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of infection exists.

In other FDA-related news, Alcon, Inc. has submitted the third and final reviewable unit of its New Drug Application (NDA) for anecortave acetate for depot suspension (Retaane 15 mg) to the FDA. Alcon is seeking approval of the drug as a treatment for patients with subfoveal choroidal neovascularization due to wet AMD.

Refractive Surgery Update

IntraLase placements surge. IntraLase Corp., which produces the IntraLase FS laser to cut the flap in LASIK surgery, said consolidated revenues for its third quarter more than doubled over the comparable prior-year period to $15.5 million.

Revenues benefited from continued growth in demand for IntraLase FS lasers, with the company placing for sale or lease 27 lasers in the quarter compared to 14 sales or leases in the third quarter of 2003. Laser revenues were $8.6 million vs. $3.4 million in the comparable quarter a year ago.

The company estimated that IntraLase lasers were used to cut the corneal flap in approximately 15% of all LASIK procedures performed in the United States in the third quarter of 2003, a 70% increase over the year-ago period.

B&L gains in refractive. Bausch & Lomb reported an impressive 22% year-over-year gain in refractive sales in the third quarter, spurred by higher sales of per-procedure cards, upgrades to the Zyoptix platform for custom LASIK, and higher sales of refractive-related diagnostic equipment.

Nidek hyperopia study. Nidek Inc. has announced 9-month clinical data from its U.S. clinical study for the treatment of hyperopia and hyperopic astigmatism with the company's EC-5000 platform. The data covers 248 treated eyes out of a total of 300 approved for this study.

At the 9-month mark, 98.1% of treated patients demonstrated uncorrected visual acuity of 20/32 or better.

"The results we have generated to date exceed and surpass FDA criteria for hyperopia approval and we look forward to collecting all the 9-month data and thereafter working with the FDA to evaluate our submission process," commented George Waring, III, M.D., medical monitor for the study and chairman of NIDEK's Medical Advisory Group.

In other news, Nidek said it has shipped its 1,000th Nidek EC-5000 Excimer Laser System. The company said this milestone establishes Nidek as the worldwide leader in excimer lasers in terms of installed base and market share.

Study: Stem Cells Can Preserve Vision
Researchers See Potential Use in Retinal Diseases.

In a groundbreaking study, researchers from Harvard's Schepens Eye Research Institute have shown that transplanted stem cells can preserve, and even improve, vision in eyes damaged by retinal disease.

The researchers said results of a mouse study demonstrated that transplanted stem cells can develop into new retinal cells, prevent the death of "at risk" retinal cells, and improve the vision of treated mice. The results were published in the November issue of Investigative Ophthalmology and Visual Science.

"These findings hold great promise for potential treatments for people suffering from macular degeneration, diabetic retinopathy and other retinal diseases," says Michael Young, Ph.D., an assistant scientist at Schepens and the lead author of the study.

Beginning with the premise that stem cells have the capacity to change into other kinds of cells, Young and his team transplanted retinal cells from young "green" mice into the eyes of normal-colored mice with retinal disease. Green mice are genetically raised so that all of their tissues are fluorescent green, which makes it possible to detect where the transplanted cells are and how they are growing and changing.

After several weeks, the team evaluated the eyes of the treated mice and found that the green cells had migrated to where they were needed in the damaged retina and had changed into what looked like normal retinal cells.

The scientists also found that many of the retinal cells that were on the verge of dying before the transplant appeared to regain or retain their function. The Schepens researchers speculated that the transplanted cells were secreting a factor or substance that saved these fragile cells.

To test whether the mice with transplanted stem cells could see better, the team then placed them and a group of nontreated control mice in separate dark cages and flashed a series of increasingly lower level lights at both groups over a period of time. Being photophobic, mice stop their normal activity when they detect light. The researchers took advantage of this natural response and found that the mice with the transplanted cells continued to respond to the light as it reached its lowest levels. The control mice did not.

The team is now investigating the use of stem cells in pigs, whose eyes are larger and more like human eyes.

IN THE NEWS

ISTA Pharmaceuticals, Inc. said the FDA has approved a single-use vial (200 USP Units/mL) of hyaluronidase injection ovine sterile solution (Vitrase) for use as a spreading agent to facilitate the dispersion and absorption of other drugs in ophthalmic procedures. Vitrase is a proprietary formulation of highly purified, preservative-free ovine hyaluronidase, which has been studied extensively in several ophthalmic conditions.

Vicente Anido, Jr., Ph.D., ISTA's CEO, said "We are pleased with the current approval and anticipate that we will launch the new vial size, as well as the previously approved 6,200 USP Units multipurpose vial, early in the first quarter of 2005. We believe the smaller-sized vial will greatly enhance the convenience of using Vitrase as a spreading agent by ophthalmologists. Further, the availability of Vitrase provides ophthalmologists with a preservative-free alternative to other available hyaluronidases, including non-FDA approved hyaluronidases sold by compounding pharmacies."

In May, the FDA approved Vitrase in a 6,200 USP Units multipurpose vial, for use as a spreading agent.

B&L gets approval. Bausch & Lomb has received approval from the FDA for an enhanced fitting guide for its Vision Shaping Treatment, a vision-correction method that uses custom-fit gas permeable contact lenses worn overnight to temporarily reshape the cornea to correct nearsightedness and low amounts of astigmatism. The fitting process includes precise measurements and computer mapping of the eye to create a custom contact lens that physically reforms the shape of the cornea.

Oxigene begins trial. Oxigene, Inc. said it has initiated a Phase II clinical trial of its lead compound Combretastatin A4 Prodrug (CA4P) in patients with myopic macular degeneration (MMD) under its Investigational New Drug application submitted to the FDA.

The Phase II clinical trial is an open label, dose-ranging, international multicentered study that will assess the safety and efficacy of CA4P in the treatment of MMD.