The FINANCIAL — VEGF Trap-Eye can achieve durable improvements in visual acuity and in biologic measurement parameters in the formation of new blood vessels in the treatment of age-related macular degeneration (AMG).
This was shown in the final evaluation of a Phase 2 study presented at the annual meeting of the Retina Society in Scottsdale, Arizona. These parameters include retinal thickness and active choroidal neovascularization lesion size (the damaged part of the retina). Bayer HealthCare and Regeneron Pharmaceuticals, Inc (Nasdaq:REGN) are developing VEGF Trap-Eye together. The treatment successes continued for up to a year.
According to Bayer, the study showed that VEGF Trap-Eye was also associated with a reduction in the size of the choroidal neovascular membrane (CNV), the active lesion that is the underlying cause of vision loss in patients with wet AMD. Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p<0.0001 versus baseline) and 5.4 letters (p<0.085 versus baseline), respectively. Patients in the 2.0 mg monthly cohort also achieved a statistically significant 1.75 mm2 reduction in total lesion size. A reduction in total lesion size was not seen in the cohort initially dosed with 0.5 mg monthly.
"Progression of the active CNV lesion and resulting vision impairment are an inevitable consequence of untreated wet AMD. The reduction in total active CNV lesion size achieved with VEGF Trap-Eye treatment in this Phase 2 clinical study could potentially translate into clinically meaningful outcomes in the larger, controlled Phase 3 studies that are underway," stated Jason Slakter, M.D., head of the independent reading center for the study and a Clinical Professor of Ophthalmology, New York University School of Medicine, New York.
In this double-masked Phase 2 trial, participants were initially treated with either monthly or quarterly fixed dosing for 12 weeks and then continued to receive treatment for another 40 weeks on a PRN (as needed) dosing schedule. Patients receiving fixed monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12 weeks (i.e. 4 fixed doses) followed by PRN dosing achieved mean improvements in visual acuity versus baseline of 9.0 letters (p<0.0001 versus baseline) and 5.4 letters (p<0.085 versus baseline), respectively, at the end of one year. The proportion of patients with vision of 20/40 or better (part of the legal minimum medical requirement for an unrestricted driver’s license in the U.S.) increased from 23 percent at baseline to 45 percent at week 52 in patients initially treated with 2.0 mg monthly and from 16 percent at baseline to 47 percent at week 52 in patients initially treated with 0.5 mg monthly. During the week 12 to week 52 PRN dosing period, patients initially dosed on a 2.0 mg monthly schedule received, on average, only 1.6 additional injections and those initially dosed on a 0.5 mg monthly schedule received, on average, 2.5 injections.
Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg for 12 weeks followed by PRN dosing also achieved mean decreases in retinal thickness versus baseline of 143 microns (p<0.0001 versus baseline) and 125 microns (p<0.0001 versus baseline) at week 52, respectively.
While PRN dosing following a fixed quarterly dosing regimen (with dosing at baseline and week 12) also yielded improvements in visual acuity and retinal thickness versus baseline at week 52, the results generally were not as robust as those obtained with initial monthly treatment.
“Anti-VEGF therapy has dramatically changed the treatment paradigm for wet AMD, and improvement in visual acuity is now feasible in most patients. The biggest challenge we have is that with our current drugs, the majority of patients need frequent injections into their eye to maintain their visual acuity gains,” stated David M. Brown, M.D., a study investigator and a retinal specialist at The Methodist Hospital in Houston.”These study results reinforce our interest in further exploring whether continued administration of VEGF Trap-Eye on an as-needed basis after an initial period of fixed dosing can maintain a durability of effect over time in controlled Phase 3 clinical studies.”
VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was one reported case of eye inflammation (culture-negative endophthalmitis/uveitis) in the study eye, which was deemed not to be drug-related. The most common adverse events were those typically associated with intravitreal injections.
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