Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced that it has dosed the first subject in its Phase 1 / 2 U.S. clinical trial (ABA-1, CLARA) of AURN001, a cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction.
ORASIS PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF QLOSI™ (PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.4% FOR THE TREATMENT OF PRESBYOPIA
Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced that the U.S. Food and Drug Administration (FDA) has approved QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is expected to be commercially available in the U.S. in the first half of 2024.
“The FDA approval of QLOSI marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the U.S. living with presbyopia, or blurry near vision,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. “I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible.”
QLOSI (pronounced CLOH-see) is a prescription eye drop that can be used daily, or as needed, up to twice per day. QLOSI demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision. QLOSI is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.
ONL Therapeutics Completes Enrollment in Phase 2 Study of First-in-Class Fas-Inhibitor in Patients with Macula-Off Rhegmatogenous Retinal Detachment
ONL Therapeutics, Inc. announced today the completion of patient enrollment in its Phase 2 clinical trial of ONL1204 Ophthalmic Solution in patients with macula-off rhegmatogenous retinal detachment (RRD). The ongoing Phase 2 clinical trial is a randomized, controlled study designed to assess 135 patients across three arms, including two treatment groups and a sham group. The goal of the study is to evaluate the safety and efficacy of a single intravitreal (IVT) injection of ONL1204 as an adjunct to standard-of-care surgical repair in subjects with macula-off RRD at 37 sites across the United States.
Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its novel cell therapy, Vyznova™, for the treatment of bullous keratopathy of the cornea. The Company believes this is the first-ever regulatory approval in the world for an allogeneic cell therapy to treat corneal endothelial disease.
ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutics to protect and improve the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. ONL is developing a platform of products for use in a wide range of blinding diseases, including retinal detachment, glaucoma, AMD and IRD.
ONL Therapeutics Closes First Tranche of $15 Million Series C Financing to Advance Lead Compound into Phase 2 Clinical Trial
ONL Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease, today announced it has closed on the first tranche of a $15 million Series C Preferred Stock financing round. Proceeds from the financing will primarily support the advancement of ONL1204 Ophthalmic Solution into a Phase 2 clinical trial in patients with macula-off rhegmatogenous retinal detachment (RRD). We expect to initiate this new U.S.-based Phase 2 study in acute retinal detachment next quarter and to continue to generate data throughout the year from our two ongoing chronic Phase 1b studies in geographic atrophy (GA) associated with age-related macular degeneration and progressing open-angle glaucoma (OAG) that are being conducted in Australia and New Zealand.
Orasis Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023.
Preliminary unaudited fourth quarter 2022 revenue is expected to be approximately $16.1 million, representing growth of approximately 91% compared to the prior year period.
Preliminary unaudited 2022 fiscal year revenue is expected to be approximately $49.0 million, representing growth of approximately 117% compared to the prior year.
Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The NDA is based on data from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of CSF-1. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events of headache and instillation site pain occurred in only 6.8% and 5.8% of participants, respectively. Of all CSF-1 participants, only 2.6% reported moderate treatment-related adverse events. All other adverse events were mild.
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that Tarsus will be added to the NASDAQ Biotechnology Index® (NASDAQ: NBI), effective December 19, 2022.
The NASDAQ Biotechnology Index is designed to track the performance of a set of biotechnology and pharmaceutical companies listed on The Nasdaq Stock Market. Companies in the Index must meet eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria. The Index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (NASDAQ: IBB). Because of this designation, shares of Tarsus will be included in the portfolios of NASDAQ Biotechnology Index funds.