The American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology have joined with the U.S. Food and Drug Administration and the National Eye Institute to form a first-of-its-kind joint task force to discuss the design of a study to identify dissatisfied post-LASIK patients, define their significant symptoms and examine the impact of those symptoms on quality of life. The task force marks the first time that the FDA has requested guidance from outside organizations regarding the design of such a study. The task force's goal is to hammer out issues involving the feasibility and design of a study.
"We are pleased to have this opportunity to collaborate with the FDA and NEI on designing the study," said Richard L. Lindstrom, MD, ASCRS president and chair of the joint task force. "ASCRS and the Academy will rely upon the best interests of patients, scientific validity and transparency to guide their actions through this process."
The FDA approached ASCRS in the fall of 2006 for guidance in designing a post-LASIK quality-of-life study. The call for this study was spurred by a few FDA petitioners who urged a moratorium on eye surgeries that were not medically necessitated. Although the FDA did not see the majority of requests as meriting new investigation, the agency consented to allow the petitioners to present testimony at a special meeting of the Ophthalmic Device Panel. The FDA has set April 24-25, 2008 for the ODP session. At this meeting panel members of the ODP will review issues related to poor outcomes from LASIK and phakic IOL devices and consider how this affects patients' quality of life.
ASCRS also launched a meta-analysis on patient reported outcomes and quality of life after LASIK. Task force member Kerry Solomon, MD, is directing the study, which will cull through the world's reported literature on quality of life after LASIK with various outcomes. He is slated to report his findings at the 2008 ASCRS ASOA Annual Symposium and Congress in
No final decisions by the joint task force regarding the need for a study or its design have as yet been made. The task force continues to explore the development of a comprehensive patient-reported quality-of-life and symptoms survey instrument; ASCRS will also share any relevant information on dissatisfied patients gleaned from the World Literature Review with all task force members.
Ultimately, joint task force recommendations will be put to the governing boards of the ASCRS and AAO to consider. Then, it will fall to the regulatory agencies to determine what, if any, steps need to be taken.
One-Year SAILOR Results Disclosed
Final one-year results from Cohort 1 of the Phase IIIb SAILOR study, which evaluated the safety of Lucentis (ranibizumab injection) in patients with wet age-related macular degeneration, were presented by David Boyer, MD, at the Bascom Palmer Eye Institutes' 2008 Angiogenesis Meeting. SAILOR is the largest randomized clinical trial ever conducted in wet AMD with about 4,300 patients. Large studies like SAILOR are important because they may be able to provide significant safety information that smaller studies may not be able to detect.
The results suggested:
• At one year, rates of adverse events in patients receiving either 0.3 mg or 0.5 mg of Lucentis were generally low and consistent with those seen in the pivotal Phase III trials
• One-year results also demonstrated that the FDA-approved dose of Lucentis (0.5 mg) was not associated with the higher rate of stroke observed during a planned interim analysis at six months. The data suggested a trend towards a higher incidence of stroke in the 0.5-mg dose group (1.2 percent vs. 0.7 percent in the 0.3-mg group), though the results were not statistically significant. (For context, the incidence of stroke in Americans aged 65 or older is 1.4 percent.)
Genentech Makes Lucentis More Widely Available
In March, Genentech began implementing enhancements to the patient and provider support programs for Lucentis (ranibizumab injection), which include Lucentis Access Solutions and the Genentech Access to Care Foundation. The enhancements are designed to improve enrollment timing and broaden eligibility requirements. New enhancements include:
• Confirmation by phone that a patient, who is uninsured or denied coverage, is or may be eligible for free drug within 48 hours in most cases.
• Conditional enrollment for eligible patients with inconclusive insurance coverage who otherwise qualify medically and financially via a letter that will be faxed to the physician's office.
• Increased support to independent non-profit co-pay organizations, with a particular focus on groups with fast and efficient processes in place, such as the Chronic Disease Fund.
• Expanded eligibility criteria for all of Genentech's products' access programs, to include patients who meet approved medical criteria and an annual adjusted gross income of up to $100,000 (previously $75,000), as well as patients who have reached their maximum lifetime insurance limits.
• Physicians and patients can contact Lucentis Access Solutions and the Genentech Access to Care Foundation at 1 (866) 724-9394 or LucentisAccessSolutions.com.
Genentech has discussed these enhancements with the AAO and the American Society of Retina Specialists to ensure that they are effectively communicated and that physicians can feel confident in using these programs when needed.
Since their first marketed product was approved, Genentech has offered a number of services to help ensure access to products, including providing free drug to eligible uninsured patients, conducting benefits investigations, assisting with prior authorizations, providing appeals and denials support, and answering billing and coding questions for physicians. Since 1985, Genentech has donated approximately $1 billion in free medicine to uninsured patients, and since 2005 has donated more than $140 million to various independent, non-profit organizations that provide co-pay assistance.
Alcon Releases Anecortave Acetate For POAG Results
Alcon released the primary efficacy and safety results of the second controlled proof of concept clinical study of anecortave acetate administered as an anterior juxtascleral depot in the sub-Tenon's space to reduce intraocular pressure in patients with open-angle glaucoma.
In the safety and efficacy study, 89 patients were randomly assigned to one of three arms: 7.5 mg of anecortave acetate dosed with 0.25 mL of 30 mg/mL suspension; 15 mg of anecortave acetate dosed with 0.5 mL of 30 mg/mL suspension or 0.5 mL of vehicle. Prior to enrolling in the study, all patients had been diagnosed with OAG, had confirmed visual field changes and had off-therapy IOPs between 24 mmHg and 36 mmHg. One injection of drug or vehicle was administered to each patient and IOPs were assessed at two weeks, six weeks and at month three, with month three predefined as the visit for primary efficacy. The study design also allowed for a patient to be retreated if more than 42 days had passed since the last administration of anecortave acetate and the patient's IOP exceeded 18 mmHg in two consecutive visits scheduled one week apart. The study will continue with clinical assessments at six-week intervals, potentially through month 24. The presented results are based on the intent-to-treat data set of all 89 patients.
The primary conclusion was that both the 7.5-mg and 15-mg doses of anecortave acetate demonstrated statistically significant lower mean IOP than vehicle at the month three primary efficacy end-point (ANOVA p< 0.05). Additional data in the presentation supported the activity of anecortave acetate in lowering IOP. Approximately 55 percent of patients in the 7.5-mg and the 15-mg arms who were treated with anecortave acetate according to the study design were deemed successes at month three. In the vehicle treatment group, approximately 50 percent of patients were treatment failures by week two, and two patients (6.4 percent) were treatment successes at month three. Treatment success was pre-defined in the study as maintenance of IOP at or below 21 mmHg. Taken together, these data support the activity of anecortave acetate and also the company's prior decision to conduct additional clinical trials involving higher concentrations of drug.
The most frequently reported adverse events were related to the procedure and included eye pain, foreign body sensation, hyperemia and blurred vision, which were reported at an incidence of 5 percent to 15 percent. The most frequently reported events related to test article were conjunctival deposits and eye pain, reported at an incidence of less than 5 percent.
