Orasis Pharmaceuticals Ltd.

The eye drop maker Ocuphire Pharma and startup Opus Genetics are merging in an all-stock deal, the companies told Endpoints News . Ocuphire $OCUP will acquire privately-held Opus and adopt its name, and will trade under the new stock ticker $IRD effective Thursday, reflecting its focus on inherited retinal diseases. The combined company will have a late-stage eye drop and a pipeline of seven AAV-based gene therapies. Ocuphire CEO George Magrath will remain in his post and Opus CEO Ben Yerxa will become president. Magrath said that at a recent conference, a speaker from the FDA “mentioned that the biggest unmet need in ophthalmology right now [is] treatments for inherited retinal disorders, so that was music to my ears.” Ocuphire shareholders will own about 58% of the combined company and Opus’ shareholders will get about 42%, according to the announcement. The combined company will have about 20 employees. Michigan-based Ocuphire went public through a reverse merger with Rexahn Pharmaceuticals in the fall of 2020. North Carolina-based Opus came out of stealth three years ago, backed with $19 million in seed funding. The company’s science is based on work from Jean Bennett, who co-founded Spark Therapeutics and co-developed its treatment Luxturna. Bennett will become a board member of the combined company. After its founding, Opus bought two preclinical gene therapies from Iveric Bio for $500,000 upfront in December 2022. Opus has raised a total of about $26 million, Yerxa told Endpoints Tuesday. Opus’ lead gene therapy is OPGx-LCA5, which is in Phase 1/2 for an early-onset retinal degeneration condition known as Leber congenital amaurosis 5. On Tuesday, the companies said three of three adults in the trial had visual improvement at six months. “We took a gamble to use our little bit of available capital to get that early clinical data,” Yerxa said. “That was really key to get to that proof-of-concept to show that this idea of curated gene therapies, hand-selected, that they would read out in a meaningful way.” The next step entails testing the therapy in three pediatric patients, and data could come in the third quarter of next year. Magrath said that if those data show similar improvement, “the door is open to discuss with the FDA what the accelerated approval would look like.” Ocuphire has experience with regulatory approval from its eye drop, which was cleared by the FDA last year for pharmacologically-induced mydriasis. The drug has been out-licensed to Viatris, which is also fully funding two Phase 3 tests of the phentolamine ophthalmic solution in dim light vision disturbances and presbyopia, a common condition that causes blurry vision. Those studies are slated to have data readouts in the first quarter and first half of 2025, respectively. Ocuphire is running the clinical development and is responsible for regulatory filings before handing off to Viatris to lead commercialization, Magrath said. The presbyopia market has had its challenges. AbbVie pulled back on promoting a product for the disease and cut a next-generation drug, while the company Orasis hasn’t yet started selling its approved drug. On Monday, Lenz Therapeutics said the FDA set an approval deadline of Aug. 8 for its eye drop LNZ100. After the merger, Ocuphire will stop working on the Ref-1 inhibitor APX3330, an oral small molecule that had failed a Phase 2 trial in diabetic retinopathy last year. It plans to look for a partner for the drug, as well as for its follow-on Ref-1 inhibitors APX2009 and APX2014 for geographic atrophy and other retina conditions, Magrath said.

Plus, news about TenNor Therapeutics, Gan & Lee Pharmaceuticals, Orasis and Optus Pharmaceuticals: Exscientia receives $15M milestone from Sanofi: The companies are advancing two programs as part of a deal first announced in 2022. Exscientia said it’s now eligible for additional milestones worth more than $600 million, in addition to royalties. — Jaimy Lee Eli Lilly brings Gateway Labs to China: The drugmaker is launching one of its Gateway Labs in China, the company said Tuesday, the day after announcing plans to open one in the UK. Lilly also said it’s opening a research hub in Beijing called the Lilly China Medical Innovation Center. — Anna Brown TenNor raises more than $42M in Series E: The Chinese company plans to use the funds to support the development and potential approval in China of rifasutenizol, its candidate for Helicobacter pylori infection. AMR Action Fund chipped in as a new investor, alongside existing supporters such as Zhongshan Venture Capital. — Ayisha Sharma Gan & Lee’s trio of diabetes drugs passes mid-stage trials: The Beijing-based biotech unveiled promising blood sugar data from its GLP-1 agonist (GZR18), once-weekly insulin analog (GZR4) and premixed dual insulin analog (GZR101) from their respective mid-stage studies. Notably, the GLP-1 agonist showed greater reductions in HbA1c and body weight than Novo Nordisk’s semaglutide. — Ayisha Sharma Orasis signs licensing deal with Korean drugmaker: Optus is paying $18 million to commercialize, import and market Qlosi, an eye drop for presbyopia, in South Korea. It plans to launch the treatment there by 2026. — Jaimy Lee

$68 Million Series D Financing Co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc. Secured $15 Million in Structured Capital from Catalio Capital Management, with $10M Drawn at Closing PONTE VEDRA, Fla., Oct. 8, 2024 /PRNewswire/ -- 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. "We are proud to collaborate with leading, high-quality investors who share our dedication to reshaping vision possibilities for presbyopes seeking a break from reading glasses," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. "This significant funding will allow us to successfully launch Qlosi, providing the eye care community a near-vision solution with a balance of efficacy and tolerability, using the lowest effective concentration of pilocarpine approved."1,2 "We are pleased to co-lead this financing and to join an experienced syndicate of investors whose collective support is further validation of the market potential for Qlosi," said Paul McCreadie, Managing Partner at Arboretum Ventures. "We have high confidence in the Orasis team to successfully launch Qlosi and generate a positive impact on patients' near vision." For more information about Qlosi and Full Prescribing Information, visit . About Orasis Pharmaceuticals Orasis Pharmaceuticals developed Qlosi, a corrective eye drop for the treatment of presbyopia in adults. Orasis is led by a collaborative team of industry executives and eye care professionals with a broad range of experiences in research, development, and commercialization of pharmaceutical drugs, as well as finance and business development. Orasis is funded by a diverse group of sophisticated and experienced life science and healthcare investors. Orasis has offices in the United States and Israel. For more information, visit and follow us on LinkedIn and X. About Qlosi Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% is a novel corrective eye drop indicated for the treatment of presbyopia in adults. Qlosi's formulation includes the lowest effective concentration of pilocarpine approved,1,2 together with a multi-faceted vehicle, and does not contain an anti-microbial preservative. Qlosi was designed to achieve a balance between efficacy, safety, and comfort.3 Qlosi improves near visual acuity by pupil modulation, resulting in a "pinhole effect" and an increase in the depth of field, thus increasing the ability to focus on near objects without negatively impacting distance. About Arboretum Ventures Arboretum Ventures, LLC ("Arboretum") is a venture capital firm, founded in 2002, specializing in the healthcare sector. The firm has raised $1 billion in capital across its funds with its most recent Fund VI closing in 2023 at $268 million. Arboretum focuses on capital‐efficient investment opportunities in medical devices, life science tools & diagnostics, tech‐enabled care delivery, and pharma adjacencies. Arboretum's guiding vision is to identify transformative healthcare companies developing novel solutions to significant healthcare issues that simultaneously reduce cost and improve outcomes. For information, visit . Qlosi Indication and Important Safety Information Indication Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, for topical ophthalmic use is a cholinergic agonist indicated for the treatment of presbyopia in adults. Important Safety Information CONTRAINDICATIONS Hypersensitivity WARNINGS AND PRECAUTIONS Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous occupations in poor illumination. Rare cases of retinal detachment have been reported with miotics. Examination of the retina is advised in all patients prior to initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss. Qlosi is not recommended to be used when iritis is present. Qlosi should not be administered while wearing contact lenses. Remove lenses prior to the installation of Qlosi and wait 10 minutes before reinsertion. Avoid touching the tip of the vial to the eye or any other surface. ADVERSE REACTIONS The most common adverse reactions (5% to 8%) are instillation site pain and headaches. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Media Contact: [email protected] 412-327-9499 References: 1 Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%. Prescribing Information. Orasis Pharmaceuticals; 2023. 2 U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed September 26, 2024. . 3 Holland E, Karpecki P, Fingeret M, et al. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clinical Therapeutics. 2024;46(2):104-113. SOURCE Orasis Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED