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Envisioning a better future for wet AMD patients
NEW YORK—Aimed at helping older people save their vision and enjoy brighter lives, Ohr Pharmaceutical Inc., an ophthalmology research and development company, plans to launch Phase 3 trials to further evaluate OHR-102 (0.2 percent Squalamine lactate ophthalmic solution) as part of a combination therapy for the treatment of the wet form of age-related macular degeneration (wet AMD).
The announcement comes on the heels of the Association for Research in Vision and Ophthalmology (ARVO) conference in Denver in early May, when Dr. Jason Slakter, Ohr’s chief medical officer and a retina specialist at Vitreous-Retina-Macula Consultants of New York, presented data showing the visual acuity outcomes for patients completing a nine-month treatment period (modified intent-to-treat or mITT population).
“The results from the IMPACT study demonstrate that topically administered OHR-102 combination therapy can lead to improved visual function in patients with wet AMD and importantly, that the efficacy results may be determined by lesion size and composition,” Slakter stated in a news release.
“There was a clear and clinically meaningful benefit in patients whose lesions contained some classic CNV,” Slakter said, CNV being choroidal neovascularization—the creation of new blood vessels in the choroid layer of the eye. “These data support a Phase 3 development program in a targeted population which will be based upon a complete analysis of the IMPACT study results. We expect to commence the Phase 3 development program with OHR-102 combination therapy in the second half of 2015.”
Slakter tells DDNews that he expects the Phase 3 program will show that the two-prong combination therapy results in the best outcome for patients with wet AMD. The dynamic duo includes the current Lucentis monotherapy injections to be paired with the OHR-102 eye drops, theoretically allowing more people to have the ability to see better, longer.
OHR-102 would be used as an additional treatment to the current injections administered by a doctor once a month, Slakter says. The OHR-102 eye drops could help increase vision and possibly be administered by the patient at home.
“An 85-year-old patient came to me recently and said her granddaughter gives her artwork,” relates Slakter, an ophthalmologist with a thriving practice in Manhattan. “As a grandmother, she is pleased and pretends to admire the little girl’s drawings, but would really like to actually see her granddaughter’s work.”
Other elderly patients want to have enough vision to legally drive a car again, he added. The combination therapy could make such dreams reality.
Slakter is in the midst of planning two Phase 3 trials in numerous hospitals across the United States. In total, 1,300 patients with wet-AMD will take part in the two trials, half of them receiving the OHR-102 eye drops, while the other half receive a placebo.
At the ARVO conference in Denver, Ohr Pharmaceutical presented Phase 2 data noting that in the mITT population with lesions containing classic CNV, mean gains in visual acuity at month nine were +11 letters for the OHR-102 combination arm and +5 letters with Lucentis monotherapy, a clinically meaningful benefit of six letters.
In addition, 44 percent of the patients receiving OHR-102 combination therapy achieved a ≥3 line vision gain at nine months, as compared to 29 percent in the Lucentis monotherapy group. This positive effect on visual acuity in classic containing CNV population was observed early in the course of treatment and continued to increase through the end of the study. This population represents approximately two-thirds of the total wet AMD patient population.
The mITT data in classic containing lesions also showed a more pronounced separation between the OHR-102 and Lucentis monotherapy groups for those patients who achieved ≥4 and ≥5 line vision gains.
Of the patients receiving OHR-102, 22 percent achieved a ≥4 line gain and 14 percent achieved ≥5 gains at nine months, as compared to 7 percent with a ≥4 line gain and 7 percent with a ≥5 line gain for those who received Lucentis monotherapy. The mITT overall population, comprising the patients with either classic containing or occult-only lesions, demonstrated a lesser benefit, with patients gaining +7.8 letters for the OHR-102 combination arm and +5.3 letters for Lucentis monotherapy.
Ohr Pharmaceutical researchers also presented data on patients with classic containing lesions in the intent-to-treat population. In this group, the mean gains in visual acuity were +10.5 letters for the OHR-102 combination arm and +5.4 letters with Lucentis monotherapy, a clinically meaningful benefit of +5.1 letters. In addition, 42 percent of the patients receiving OHR-102 achieved a ≥3 line gain at nine months, as compared to 28 percent in the Lucentis monotherapy group.