FDA Approves Phase III Study of Inlay for Presbyopia

ReVision Optics, Inc. (RVO), has received conditional approval from the U.S. Food and Drug Administration (FDA) to continue and complete enrollment in its Phase III clinical trial with its Raindrop™ Near Vision Inlay (formerly the PresbyLens). The prospective, multicenter Phase III clinical trial is evaluating the safety and effectiveness of the Raindrop Near Vision Inlay in improving near vision in subjects with presbyopia under an Investigational Device Exemption (IDE). Read more.

Implants for Presbyops Work, Says Study

“Patient satisfaction at 12 months was very positive with 9 patients reporting to be ‘completely satisfied,’ 3 were ‘very satisfied’ and 1 was ‘somewhat satisfied,’” said John Olkowski about the clinical results of a single-center study, The chief surgeon at EyeSight Hawaii explained at the International Society of Presbyopia Fourth Annual Conference in Milan that the study showed significant improvement in near visual acuity following treatment with Raindrop Near Vision Inlay (formerly the Vue+ and PresbyLens), products created by ReVision Optics, Inc. (RVO).  Significant improvement in this group of patients reportedly was observed within 7 days of treatment. Data showed that at one week following treatment with the Raindrop in the non-dominant eye, 19 of 25 subjects achieved uncorrected 20/25 or better near visual acuity with an average gain in near vision of 4 lines using the Optec 6500 visual acuity tester, according to RVO. Read more.

ReVision Releases Raindrop Near Vision Inlay Brand

ReVision Optics, Inc. (RVO), has released its Raindrop Near Vision Inlay as a replacement brand for Vue+ in the European Union, where it has received CE Mark and is commercially available, and PresbyLens in the United States, where it is currently being investigated in a Phase III clinical trial. The company will unveil the brand at next week’s ESCRS 2012, the XXX Congress of the European Society of Cataract & Refractive Surgeons, in Milan. The inlay is said to be designed as a surgical option for near and intermediate vision enhancement. In a 10-minute procedure, the two-mm diameter inlay is placed on the cornea of the patient’s non-dominant eye, where it microscopically changes the shape of the cornea’ surface. The inlay, which is approximately 80% water, reportedly is bioengineered to facilitate the normal or physiologic transport of nutrients and fluids within the cornea.Read more.

ReVision's PresbyLens Enters Phase 3 of Trials

ReVision Optics, Inc. (RVO), a leader in implantable inlay technology to treat presbyopia, announces the advancement of its proprietary product PresbyLens into the final phase of its U.S. clinical trial under an Investigational Device Exemption (IDE). PresbyLens is a clear, circular corneal inlay comprised of approximately 80% water and is less than half the thickness of a human hair. The Phase 3 clinical trial will evaluate the safety and effectiveness of the PresbyLens in improving near vision in subjects with presbyopia. In this prospective, multi-center trial, subjects will be implanted with the PresbyLens in their non-dominant eye. Read more.