Orasis Pharmaceuticals Completes $78 Million Financing to Support Commercial Launch of Qlosi™

News, Orasis

Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced the completion of a $78 million financing to support the commercial launch of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel corrective eye drop for the treatment of presbyopia in adults. The Series D financing included a $68 million equity component, co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc., along with participation from Catalio Capital Management, Freepoint Capital Group, and returning investors—Visionary Ventures, Bluestem Capital, SBI (Japan) Innovation Fund, Sequoia Capital, and Maverick Ventures, as well as other individuals. Concurrent with its equity raise, Orasis has secured $15 million in structured capital from Catalio Capital Management, of which $10 million will be drawn at closing.

“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.

Iantrek Announces Publication of Results of its Bio-interventional Uveoscleral Outflow Technology in Patients with Open-Angle Glaucoma

Iantrek, News

Iantrek, Inc., a venture-backed, medical technology company pioneering next-generation bio- and micro-interventional approaches for the treatment of ophthalmic diseases, today announced that clinical results of its uveoscleral outflow technology in 243 eyes with open-angle glaucoma were published in the peer-review Journal of Clinical Medicine. Topline results were presented earlier this year at the 2024 American Society of Cataract and Refractive Surgery Annual Meeting in Boston, MA.

ONL Therapeutics Closes $65 Million In Oversubscribed Series D Financing

News, ONL

ONL Therapeutics has secured $65M in Series D financing to advance the development of ONL1204 Ophthalmic Solution with the initiation of a Phase 2 global study for the treatment of geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Johnson & Johnson Innovation – JJDC, Inc. led the round that was backed by a consortium of investors that included Bios Partners, Novartis Venture Fund, and Visionary Ventures, amongst others.

Pelage Pharmaceuticals AdvancesClinical Program with First PatientsDosed in Phase 2 Study for Hair Lossand GV-Led $14M Series A-1

News, Pelage

Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, today announced that the first patients have been dosed in its Phase 2a clinical trial evaluating the safety and efficacy of PP405. Pelage also raised a $14 million Series A-1, led by GV with support from Main Street Advisors, Visionary Ventures, and YK BioVentures, following an initial $16.75 million Series A financing announced in February 2024. The Series A-1 follows positive Phase 1 data, which demonstrated proof of mechanism and target engagement in patients with androgenetic alopecia, supporting a Phase 2 study.

Perry J. Sternberg Joins Sydnexis as Chief Executive Officer

News, Sydnexis

Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company focused on the treatment of progression of pediatric myopia, is excited to announce the appointment of Perry J. Sternberg as Chief Executive Officer and as a member of the Board of Directors. An accomplished pharma/biotech executive with over 30 years in the industry and 15 years in eye care, Perry will provide invaluable leadership experience to help guide Sydnexis’ strategic direction and next phase of growth.

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Pelage Pharmaceuticals

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Pelage Pharmaceuticals (Pelage) is a clinical-stage biopharmaceutical company committed to developing first-in-class therapeutic based on breakthrough discoveries to activate hair growth through a mechanism that targets the metabolism of hair follicle stem cells. The product is currently being clinically tested for all genders, skin types, and hair types.

Pelage Pharmaceuticals Announces $16.75M Series A Financing led by GV to Revolutionize Regenerative Medicine for Hair Loss

News, Pelage

Pelage Pharmaceuticals, a clinical-stage regenerative medicine company pioneering a new generation of treatments for hair loss, announced today that the company has closed a $16.75 million Series A financing led by GV with participation from Main Street Advisors, Visionary Ventures and YK BioVentures, to advance a first-in-class treatment for androgenetic alopecia or pattern baldness, and other types of alopecia including chemotherapy-induced hair loss. The Phase 1 trial evaluating PP405, a novel topical agent designed to treat androgenetic alopecia and other forms of hair loss, showed 0.05% PP405 topical treatment for seven days is safe and tolerable with no adverse events, and provided confirmation of a daily dosing regimen. Importantly, the study demonstrated biological activity, proof of mechanism of action seen in preclinical studies, and showed treatment with PP405 stimulated statistically significant activation of a critical hair follicle stem cell activation marker.

ORASIS PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF QLOSI™ (PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.4% FOR THE TREATMENT OF PRESBYOPIA

News, Orasis

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

News, ONL

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.