Lux Biosciences (Jersey City, N.J.) has completed patient enrollment in the Phase III Lux Corneal Transplant Implant Development and Advancement of Therapy—dubbed LUCIDA—clinical trial program for Lumitect, formerly known as LX201. LX201 is a silicone matrix ocular (episcleral) implant designed to provide the continuous release for one year of therapeutic levels of cyclosporine A locally to the eye to prevent corneal transplant rejection.
The LUCIDA clinical trial program is investigating the 1-year use of LX201 in 493 patients at elevated immune-mediated risk of rejection or graft loss subsequent to cornea transplantation. The program has three protocols: The two masked, placebo-controlled studies are identical protocols in distinct geographic regions in which high-risk cornea transplant patients receive a LX201 implant at the time that penetrating keratoplasty is performed. The first includes 190 patients in the U.S. and Germany; the second includes 181 patients in India. A third protocol was discontinued after slow enrollment, but safety data from those who were enrolled will be used in the overall data.
Lux Biosciences expects data from the first of two pivotal LUCIDA studies later in 2009, while data from a second study would become available in the first half of 2010, the company said in a press release.
Lumitect is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for 1 year, the company said. Two different dose level implants are being studied, a 0.75 inch implant that elutes approximately 20-25 µg/day of cyclosporine A, and a 0.5 inch implant that elutes approximately 15 µg/day of cyclosporine A. The device is implanted under the eyelid into the subconjunctival space. It has received Orphan Drug status in both the United States and Europe, and Fast Track status in the United States.

A Phase 1a trial of an orally administered synthetic retinoid replacement for 11-cis-retinal has shown promising results, said developer QLT (Vancouver, Canada) in a press release. QLT091001 was found to be safe and well-tolerated and achieved its primary goal of estimating an appropriate dose for studies in patients during the Phase 1a trial. The drug is being developed for the potential treatment of Leber's Congenital Amaurosis (LCA), an inherited progressive retinal degenerative disease that leads to retinal dysfunction and visual impairment beginning at birth. The Phase 1a trial is an open-label, single center, ascending dose trial to evaluate the safety and tolerance of multiple administrations of the synthetic retinoid drug in 20 healthy adult volunteers. Participants were enrolled in 6 cohorts of increasing doses. Patients in the highest dose cohort reported mild adverse events (including facial flushing and headache) that were transient in nature and were resolved during the treatment period, QLT said. These are expected adverse events in the retinoid class, the company added. No serious adverse events related to the study treatment were reported. The company expects to initiate a Phase 1b trial later this year in pediatric patients with LCA. 

LCA-Vision (Cincinnati, Ohio) has reduced the number of laser platforms it will use in its LasikPlus venues to just two—the Visx Star S4 IR (Abbott Medical Optics, Santa Ana, Calif.) and the Allegretto Wave Eye-Q 400 Hz (Alcon, Fort Worth, Texas). The company said in a news release that the decision was made “following a first-of-its-kind rigorous contralateral prospective randomized study, comparable to a Food and Drug Administration clinical study.” The company said all its excimer lasers performed well, and that the decision was “influenced by the economics negotiated with individual manufacturers and savings associated with supporting fewer platforms.”

As part of its EyeSmart campaign to empower Americans to take charge of their eye health, the American Academy of Ophthalmology (AAO, San Francisco) has launched "Ask an Eye M.D.," a new online service through which the public can submit questions about their eyes to a panel of ophthalmologists. A number of questions will be selected for answers from among those submitted, with the responses posted online. “Our hope is that the service will educate the public about eye health issues, so that people can know their risks and save their sight,” said H. Dunbar Hoskins Jr., M.D., executive vice president of the Academy. The EyeSmart campaign is sponsored by the Academy in partnership with EyeCare America, a public service program of the Foundation of the AAO. In addition, more than 80 state, local and specialty ophthalmology societies are lending their support to the campaign. People can submit questions at .

EYEWORLD WEEK Online edited by David Laber and Enette Ngoei

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Monday, distributed by e-mail, and posted live on Monday mornings.

Chief Medical Editors: Stephen A. Obstbaum, M.D., and Stephen S. Lane, M.D.

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