Aurion Biotech Receives Approval from Japan’s PMDA for New Drug Application

Aurion, News

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.

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ONL Therapeutics

Companies

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

News, ONL

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 Submits New Drug Application for Investigational Novel Eye Drop Candidate

News, Orasis

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 Added to NASDAQ Biotechnology Index

News, Tarsus

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.

Re-Vana Therapeutics Raises $11.9 Million in Series A Financing

News, Re-Vana

Re-Vana Therapeutics Ltd, a privately-held specialty drug delivery company developing sustained-release therapeutics for the treatment of vision-threatening ocular diseases, today announced the closure of its Series A round with $11.9 million in funding, an oversubscription of $4 million. The financing was led by Visionary Ventures. Additional investors include ExSight Ventures, InFocus Capital Partners and existing U.K. investors, Qubis Ltd, Co-Fund NI, and TechStart Ventures. Re-Vana has demonstrated that its groundbreaking platform can achieve 6 months or greater sustained delivery of an anti-VEGF biologic at therapeutically-relevant levels with high drug loading, controlled burst release, and a favorable degradation profile.

Aurion Biotech Wins Prestigious Prix Galien Startup Award

Aurion, News

Visionary portfolio company, Aurion Biotech, whose mission is to restore vision to millions of patients with its life-changing regenerative therapies, today announced it has won the prestigious Prix Galien Award for Best Startup in Biotech / Pharma. The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, fosters, recognizes, and rewards excellence in scientific innovation to improve the state of human health. Aurion Biotech received the Best Start-up in Biotech / Pharma award, one of six different award categories, and was chosen from more than 146 products from 129 nominee companies, spanning 14 therapeutic areas. According to the Galien Foundation, the Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.

TearClear Announces Positive Top-Line Results from Clear Phase 3 Study for Treatment of Glaucoma

News, TearClear

TearClear, an ophthalmic pharmaceutical company that transforms trusted drugs into branded best-in-class therapies, announced today that the company’s lead product, TC-002 (latanoprost ophthalmic solution 0.005%) met the primary and all secondary endpoints in the CLEAR Phase 3 pivotal trial. With these results, TearClear plans to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first quarter of 2023. Upon approval, TC-002 will offer patients the first and only means of delivering preservative-free doses of latanoprost from conventional multi-dose bottles.