Presbia announces 2-year Microlens data from PMA trial

Presbia (NSDQ:LENS) touted interim data today from its U.S. pivotal clinical trial, which it hopes will eventually support pre-market approval from the FDA for its Flexivue Microlens. The company is 2 years into the 3-year long trial and said that it anticipates submitting final data to the FDA in September 2017. The company’s lens is intended to correct presbyopia, farsightedness that is often age-related. Presbia’s custom lenses are implanted in the patient’s non-dominant eye in the hopes of helping the patient see near objects more clearly. To place the microlens in a patient’s eye, a small pocket is created in the cornea using a femtosecond laser and following the implantation, the pocket seals naturally and the lens sits at the center of the visual axis. The Flexivue lens was developed to take advantage of binocular vision – when patients use both eyes and the images are fused in the brain, according to Presbia. Through November 30 of this year, the trial has enrolled 421 participants. All of the study subjects have passed through the 12 month post-operative visit. Presbia said that participants gained, on average, 5 lines of uncorrected near visual acuity in treated eyes. More than 80% of patients achieved at least 20/40 uncorrected distance vision and 98% of participants achieved 20/40 best corrected distance vision in the treated eyes, according to regulatory filings. LENS shares were trading at $3.69 in mid-morning ac...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Implants Optical/Ophthalmic Regulatory/Clearance Presbia Source Type: news

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CONCLUSION: Using Ologen as drug depot for bevacizumab in a trabeculectomy (TE) with MMC is a safe and active surgical method without an increased risk of complications in comparison to pure TE with MMC or TE with MMC and Ologen implant. After 12 months, this treatment exhibited no significant advantages. PMID: 30736077 [PubMed - as supplied by publisher]
Source: Klinische Monatsblatter fur Augenheilkunde - Category: Opthalmology Tags: Klin Monbl Augenheilkd Source Type: research
CONCLUSIONS AND SIGNIFICANCE: Auditory information is a relevant cue when somatosensory and visual inputs are modified and range of vestibular function influence in a dynamic motor activity as gait, facts which must be considered in the neurodevelopment control. PMID: 30729843 [PubMed - as supplied by publisher]
Source: Acta Oto-Laryngologica - Category: ENT & OMF Authors: Tags: Acta Otolaryngol Source Type: research
Conclusions: Single IVD could significantly decrease macular edema and improve visual outcome for eyes with persistent long-term macular edema after macular ERM removal and the effect can be sustained as long as 6 months after the initial injection. However, in order to maintain the visual and anatomical outcome, repeat IVD might be considered if macular edema recurs. PMID: 30693103 [PubMed]
Source: Journal of Ophthalmology - Category: Opthalmology Tags: J Ophthalmol Source Type: research
ConclusionsIn this small case series with long-term follow-up, treatment of non-infectious uveitic macular edema with the injectable fluocinolone acetonide implant was associated with improved central retinal thickness and corrected distance visual acuity and a manageable safety profile. The advantage of this device is the long-term drug release and the fact that it can be injected into the vitreous as a minor surgical procedure, which is in contrast to other treatment options.
Source: Journal of Ophthalmic Inflammation and Infection - Category: Opthalmology Source Type: research
ConclusionsTo the best of our knowledge, this is the first report of fluocinolone acetonide intravitreal therapy in a patient with corneal disease. In the 6-month follow-up period, no surgical intervention was needed in the eye with the fluocinolone acetonide implant, whereas further penetrating keratoplasties and amniotic membrane transplants were performed in the fellow eye. Intravitreal fluocinolone acetonide may be considered as a treatment option in severe cases of autoimmune corneal disease.
Source: Journal of Medical Case Reports - Category: General Medicine Source Type: research
Conclusion: AADI is a safe and effective treatment for the control of intraocular pressure in patients with glaucoma.
Source: Indian Journal of Ophthalmology - Category: Opthalmology Authors: Source Type: research
Discussions about a global FDA In recent years, with the digitization of healthcare and the spread of communication technologies, the idea of borderless health started to emerge, and we expect it to reach a tipping point and represent a widespread practice instead of a sporadic phenomenon soon. The Medical Futurist expects to see the increase in the supply and demand of cross-border health services in the coming months. Just imagine a French patient sending a tissue of his tumor to a Belgian company specializing in precision diagnostics. They establish that a Swiss pharma company has the exact type of clinical trial that t...
Source: The Medical Futurist - Category: Information Technology Authors: Tags: Business Future of Medicine Medical Professionals Patients Policy Makers Researchers 3d printing bioprinting blockchain car digital digital health digital health trends fda genomics Healthcare Organovo smartwatch Source Type: blogs
When a patient walks into Dr. Jason Yong’s clinic at Brigham &Women‘s Faulkner Hospital complaining of pain, his work has just begun. “Pain is a common symptom and it’s totally generic,” Yong explained to MassDevice. “The other thing that makes it challenging is that it’s so subjective.” After Yong exhausts the pharmaceutical possibilities for managing his patient’s pain, he turns to technological options such as implantable neuromodulation systems. Neuromod devices use electrodes to deliver stimulation directly to a patient’s brain, spinal cord or peripheral ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Neurological Pain Management Wall Street Beat Abbott Brigham & Women's Hospital Source Type: news
(University of East Anglia) New research from the University of East Anglia (UK) uses an improved laboratory model to simulate cataract surgery on human donor eyes. During cataract surgery, the eye's cloudy natural lens is removed and replaced with an artificial intraocular lens (IOL). The research team's latest human model allows evaluation of IOL implants under conditions that mimic the inflammation that patients experience after cataract surgery. It is hoped that the model will aid the development of next generation lenses.
Source: EurekAlert! - Social and Behavioral Science - Category: International Medicine & Public Health Source Type: news
Glaukos is probably at the top of its game when it comes down to maintaining a presence in the micro-invasive glaucoma surgery (MIGS) market. The San Clemente, CA-based company reaffirmed its laser-like focus on the market during a presentation at the 37th annual J.P. Morgan Healthcare Conference earlier on Wednesday. Glaukos’ CEO Thomas Burns began his presentation speaking on the strengths of the firm and its goals going forward. “Our mission is aspirational,” Burns said. “As a company we are seeking to transform glaucoma therapy, and in doing so we ...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
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