Phase III RCT comparing salivary flow rate of Transcutaneous Electrical Nerve Stimulation (TENS) versus Pilocarpine in patients who are receiving parotid sparing VMAT in Head and Neck Cancer patients - Nil

Start Date21 Oct 2024

Sponsor / Collaborator-

CTR20242702 / CompletedPhase 1

盐酸毛果芸香碱滴眼液在老视患者中随机、双盲、单次和多次给药的药代动力学研究

[Translation] A randomized, double-blind, single-dose and multiple-dose pharmacokinetic study of pilocarpine hydrochloride eye drops in presbyopic patients

主要研究目的：评价盐酸毛果芸香碱滴眼液受试制剂与参比制剂盐酸毛果芸香碱滴眼液（Vuity）的药代动力学特征。次要研究目的：考察受试制剂和参比制剂在受试者给药后的安全性。

[Translation]

The main purpose of the study is to evaluate the pharmacokinetic characteristics of the test preparation of pilocarpine hydrochloride eye drops and the reference preparation of pilocarpine hydrochloride eye drops (Vuity). The secondary purpose of the study is to investigate the safety of the test preparation and the reference preparation after administration to the subjects.

Start Date14 Aug 2024

Sponsor / Collaborator

Nanjing Zenkom Pharmaceutical Co., Ltd.

[+1]

IRCT20240502061625N1 / SuspendedPhase 1/2IIT

Comparison of the effect of oral gel pilocarpine 2% and ginger 25% in patients with dry mouth after radiotherapy

Start Date13 Jul 2024

Sponsor / Collaborator

Islamic Azad University

100 Clinical Results associated with Pilocarpine Hydrochloride

100 Translational Medicine associated with Pilocarpine Hydrochloride

100 Patents (Medical) associated with Pilocarpine Hydrochloride

6,870

Literatures (Medical) associated with Pilocarpine Hydrochloride

01 Dec 2024·JOURNAL OF ETHNOPHARMACOLOGY

Salvinorin A ameliorates pilocarpine-induced seizures by regulating hippocampal microglia polarization

Article

Author: Wu, Tong-Xuan ; Ji, Miao-Jin ; Yang, Jiao ; Cai, Ji-Heng ; Zhou, Chao ; Wu, Qi ; Gao, Zhi-Qiang

ETHNOPHARMACOLOGICAL RELEVANCE:

Salvia divinorum (Epling and Játiva) is a psychoactive plant traditionally used by the Latinos for various medicinal purposes. Salvinorin A (Sal A), the main bioactive constituent of S. divinorum, is a natural highly selective kappa opioid receptor (KOR) agonist. Considering the anti-inflammatory effect of S. divinorum and endogenous hippocampal dynorphin/ kappa opioid receptor (KOR) system playing an anticonvulsant function, we hypothesis that Sal A can be a potential candidate to treat epilepsy. Here, we identified whether Sal A ameliorated epileptic seizures and neuronal damages in animal model and in vitro model and investigated its underlying mechanisms.

MATERIALS AND METHODS:

Mice epilepsy model was induced by pilocarpine following seizures assessed by Racine classification. Hippocampus tissues were obtained for genetic, protein, and histological investigation. Furthermore, lipopolysaccharide (LPS)-activated BV2 microglial cells were utilized to validate the anti-inflammatory and microglia polarization regulation effects of Sal A.

RESULTS:

Sal A treatment significantly prolonged the latency to status epileptics (SE) and shortened the duration of SE in the pilocarpine-induced model. It also alleviated neuronal damages via activation of the AMPK/JNK/p-38 MAPK pathway and inhibition of apoptosis-related protein in hippocampus tissues. Furthermore, Sal A dose-dependently reduced microglia-mediated expression of pro-inflammatory cytokines and increased anti-inflammatory factors levels in SE mice and LPS-activated BV2 microglial cells by regulating microglia polarization. In addition, the effect of Sal A in vitro was totally blocked by KOR antagonist nor-BNI.

CONCLUSION:

Sal A treatment protects against epileptic seizures and neuronal damages in pilocarpine-induced models by suppressing the inflammation response through regulating microglial M1/M2 polarization. This study might serve as a theoretical basis for clinical applications of Sal A and its analogs and provide a new insight into the development of anti-seizure drugs.

01 Dec 2024·NEUROPHARMACOLOGY

Effects and mechanisms of anterior thalamus nucleus deep brain stimulation for epilepsy: A scoping review of preclinical studies

Review

Author: Betta, Victor Hugo Cardoso ; dos Santos, Pedro Bastos ; Motta Pollo, Maria Luiza ; Gimenes, Christiane ; Hamani, Clement ; Covolan, Luciene ; Saad Barbosa, Felipe Farinha ; Covolan, Luciano Arnaldo Mian ; Dos Santos, Pedro Bastos

Deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) is a safe and effective intervention for the treatment of certain forms of epilepsy. In preclinical models, electrical stimulation of the ANT has antiepileptogenic effects but its underlying mechanisms remain unclear. In this review, we searched multiple databases for studies that described the effects and mechanisms of ANT low or high frequency stimulation (LFS or HFS) in models of epilepsy. Out of 289 articles identified, 83 were pooled for analysis and 34 were included. Overall, ANT DBS was most commonly delivered at high frequency to rodents injected with kainic acid, pilocarpine, or pentylenetetrazole. In most studies, this therapy increased the latency to the first spontaneous seizure and reduced the frequency of seizures by 20%-80%. Electrophysiology data suggested that DBS reduces the severity of electrographic seizures, decreases the duration and increases the threshold of afterdischarges, reduces the power of low-frequency and increase the power high-frequency bands. Mechanistic studies revealed that ANT DBS leads to a series of short- and long-term changes at multiple levels. Some of its anticonvulsant effects were proposed to occur via the modulation of serotonergic and adenosinergic transmission. The latter seems to be derived from the downregulation of adenosine kinase (ADK). ANT DBS was also shown to increase hippocampal levels of lactate, alter the expression of genes involved in calcium signaling, synaptic glutamate, and the NOD-like receptor signaling pathway. When delivered during status epilepticus or following the injection of convulsant agents, DBS was found to reduce the expression of proinflammatory cytokines and apoptosis. When administered chronically, ANT DBS increased the expression of proteins involved in axonal guidance, changed functional connectivity in limbic circuits, and increased the number of hippocampal cells in epileptic animals, suggesting a neuroprotective effect.

01 Dec 2024·BRAIN RESEARCH

Metformin alleviates reactive gliosis and neurodegeneration, improving cognitive deficit in a rat model of temporal lobe epilepsy

Article

Author: Medhi, Bikash ; Anand, Shashi ; Minz, Ranjana W ; Bojja, Sree Lalitha

Cognitive impairment is a prevalent co-morbidity associated with epilepsy. Emerging studies indicate that neuroinflammation could be a possible link between epilepsy and its comorbidities, including cognitive impairment. In this context, the roles of glial activation, proinflammatory mediators, and neuronal death have been well studied and correlated with epilepsy-associated cognitive impairment in animal studies. While recent reports have demonstrated the anti-epileptogenic and anti-convulsant actions of metformin, its effect on epilepsy associated cognitive deficit remains unknown. Therefore, the current study investigated the effect of metformin treatment on neuroinflammation, neurodegeneration, and cognitive deficits after inducing status epilepticus (SE) with lithium-pilocarpine in rats. Metformin treatment improved the hippocampal-dependent spatial and recognition memory in Morris water maze and Novel object recognition tasks, respectively. Further, metformin treatment attenuated microglial and astroglial activation, accompanied by reduced IL-1β, COX-2 and NF-ĸβ gene expression. Additionally, metformin conferred neuroprotection by inhibiting the neuronal death as assessed by Nissl staining and transmission electron microscopy. These findings suggest that metformin holds promise as a therapeutic intervention for cognitive impairment associated with epilepsy, possibly through its modulation of glial activation and neuronal survival. Further research is needed to elucidate the precise mechanisms and to assess the long-term effect of metformin in epilepsy-associated cognitive impairment.

News (Medical) associated with Pilocarpine Hydrochloride

28 Oct 2024

·www.globenewswire.com

CORXEL and LENZ Therapeutics Announce Positive Topline Data from China Phase 3 Presbyopia Trial of LNZ100

Primary endpoint was met with 74% of participants dosed with LNZ100 achieving three-lines or greater improvement at 3 hours post treatment，and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). The difference in efficacy was statistically significant in the LNZ100 treatment group compared to the vehicle group (p<0.0001) Rapid onset and long duration shown with 69% of participants achieving three-lines or greater improvement at 30 minutes and 30% at 10 hours 91% of participants indicated they noticed an improvement in their near vision LNZ100 could potentially be the best-in-class non-invasive treatment for presbyopia SHANGHAI, China and SAN DIEGO, Oct. 27, 2024 (GLOBE NEWSWIRE) -- Corxel Pharmaceuticals (CORXEL) and LENZ Therapeutics (Nasdaq: LENZ) today announced positive topline data from the Phase 3 JX07001 clinical trial of LNZ100 in patients with presbyopia in China. CORXEL is a leading biotech company committed to bringing innovative science and medicines to underserved patients with serious and life-threatening diseases. LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia. In this China Phase 3 safety and efficacy trial, LNZ100 (1.75% aceclidine HCl) achieved the primary endpoint and key secondary endpoints, with statistically significant three-lines or greater improvement in Best Corrected Distance Visual Acuity (BCDVA) at near, and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). More results showed (all p<0.0001): Rapid onset: 84% and 69% achieved two-lines and three-lines or greater improvement at 30 minutes respectively.3 hours post treatment: 88% and 74% achieved two-lines and three-lines or greater improvement at 3 hours respectively，and maintained their optimal distance visual acuity (i.e., not losing 5 or more letters).Long duration: 61% and 30% achieved two-lines and three-lines or greater improvement at 10 hours respectively. LNZ100 was well-tolerated with no serious treatment-related adverse events observed in the trial. The study was a Phase 3, multicenter, randomized, double-blind, vehicle-controlled study, including a 4-week efficacy study followed by a 5-month extension safety study, designed to evaluate the efficacy and safety of LNZ100 (an aceclidine-based ophthalmic solution) in participants with presbyopia. The objectives were to assess the potential of LNZ100 to improve near vision among Chinese presbyopia patients and to evaluate the efficacy and safety profiles.  The trial has enrolled 300 participants, with a broad enrollment criteria of between 45 and 75 years of age with a refractive range of -4.0D SE to +1.0D SE, including those who had undergone laser-assisted cornea refractive surgery/monofocal IOL implantation. Professor Jia Qu, Principal Investigator and Co-Principal Investigator，Vice Chairman of Ophthalmology Branch, Chinese Medical Association, Director of optometry department, Wenzhou Medical University said: “we are very pleased with the results of the LNZ100 trial, particularly the significant efficacy and favorable safety profile of LNZ100 in patients with presbyopia, demonstrating an important advance in the field of presbyopia treatment in China. Currently, patients mainly rely on wearing eyeglasses as treatment for presbyopia. There is a large unmet need for non-invasive and reversible treatments. We expect that LNZ100 will fill this vacuum and become an innovative force in the treatment of presbyopia in China, providing more patients with the hope of clear vision." Professor Fan Lyu, Principal Investigator and Co-Principal Investigator，Head of optometry working-group under Ophthalmology Branch, Chinese Medical Association, Director of National Clinical Medical Research Centre for Eye Diseases said: "The main active ingredient of LNZ100, aceclidine, causes temporary pupil constriction, resulting in an optical effect that significantly extends the depth of focus and improves the quality of vision. The statistically significant data and clinically meaningful outcomes observed in the trials provide strong support for the efficacy and safety of LNZ100. We anticipate that LNZ100 will be a practical treatment option for a wide spectrum of patients and will have a favorable impact on paradigm shift of helping improve near-vision in the Chinese presbyopia population. “We are especially grateful to all the hard-working and dedicated researchers, partner organizations and all the volunteers who participated in the study,” Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL, said. “The common goal is to benefit hundreds of millions of people around the world, to set an international leading research benchmark, and to introduce novel treatment concepts and potentially optimal products to China first, providing a safe and convenient treatment option for the vast number of presbyopia patients. Looking ahead, we will actively communicate and cooperate with drug regulatory authorities to expedite the submission and approval of LNZ100. We believe that LNZ100 will not only significantly improve patients' vision and quality of life, but will also have a profound impact on the field of presbyopia treatment and research in China.” “We would like to first congratulate the team at CORXEL for their effort in their Phase 3 clinical study in China. We are pleased with the impressive and consistent performance demonstrated by LNZ100 in our collective studies, further validating the vision of targeting an ‘all eyes, all day’ solution,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “With this data, we believe LNZ100 has further enhanced its potential as a global therapy and is further on its path towards providing access to the estimated 400 million people with presbyopia in China. This data signifies a tremendous joint effort between the CORXEL and LENZ teams and comes in rapid succession to the recent FDA acceptance of our New Drug Application for LNZ100 in the United States.” About PresbyopiaPresbyopia is a physiological phenomenon associated with aging that results in a progressively worsening ability to see nearby objects clearly. It is caused by the gradual hardening of the lens. This results in a decline of the eye's adjustment function, and the inability to focus the image of nearby objects on the retina, leading to a decline in near vision. Studies have shown that the onset of presbyopia typically occurs around the age of 38, reaching a prevalence rate of nearly 100 percent at the age of 52 in China. It is estimated that more than 400 million people in China suffer from presbyopia.  Currently, the treatment options for presbyopia are very limited. Wearing glasses requires frequent removal and insertion, causing many inconveniences in work and life. Surgery, as an irreversible invasive operation, has a very limited acceptance. There are no approved drugs for the treatment of presbyopia in China and the medical need for non-invasive, safe, efficient and reversible treatments for presbyopia remains unsolved.  About LNZ100LNZ100 (aceclidine) eye drops are being developed by LENZ Therapeutics and CORXEL acquired the Greater China rights for the development and commercialization in April 2022. LNZ100 is formulated with aceclidine, a miotic, and designed to achieve optimal pupil diameter without impacting distance vision, a key limitation of other miotics. Miotics are compounds that cause pupil constriction, or miosis, creating a pinhole effect that enables better focus of incoming light from near objects onto the retina. Research has shown that a pupil diameter below two millimeters (2 mm) is optimal for presbyopia treatment and results in clinically meaningful improvement in near vision. Unlike other miotics such as pilocarpine and carbachol, aceclidine’s mechanism of action is pupil-selective, meaning it can activate the iris sphincter muscle and cause miosis of the pupil to a diameter below 2 mm without overstimulating the ciliary muscles that can cause a myopic shift and impair distance vision. As a result, aceclidine does not require any remaining accommodation to improve near vision, broadening its benefits to older presbyopes whose lens has lost this capacity. Therefore, we expect that users may be able to benefit from treatment even as they age from mid-40s to well into their mid-70s and across a broad range of refractive errors, as demonstrated in clinical testing to date. About CORXELCORXEL, formerly named Ji Xing Pharmaceuticals, is a leading biotech company headquartered in US and China committed to bringing innovative science and medicines to underserved patients with serious and life-threatening cardiometabolic diseases. Backed by RTW Investments, CORXEL was founded in 2019 to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in diseases. With a strong and further developing asset pipeline, industry leading talent, and patient-centric focus, CORXEL is dedicated to deliver a meaningful and lasting impact on patients. The full portfolio of CORXEL consists of 2 assets with global rights and 4 assets with Greater China rights in late-stage clinical development. The portfolio with global rights are JX09 for hypertension and JX10 for acute ischemic stroke (AIS), while the portfolio with Greater China rights include aficamten, etripamil, varenicline solution nasal spray/US brand name TYRVAYA®, and LNZ100. For further information about CORXEL, please visit www.corxelbio.com.   About LENZ TherapeuticsLENZ Therapeutics is a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in patients with presbyopia. LENZ’s product candidate, LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. LNZ100 was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. LENZ is committed to commercializing an ideal pharmaceutical presbyopia solution that enhances vision for “all eyes, all day”. LENZ is headquartered in San Diego, California. For more information, visit: LENZ-Tx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of United States federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of LNZ100 to have best-in-class performance and LNZ100 as a global therapy; the size of the addressable population for LNZ100; expectations regarding the commercial opportunity and beneficial characteristics of LNZ100; and plans and expectations regarding commercialization of LNZ100, if approved. These statements are based on numerous assumptions concerning the development of LENZ’s products and target markets and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements, including those risk factors described in the section titled “Risk Factors” in LENZ’s Quarterly Report on Form 10-Q filed for the quarter ended June 30, 2024 and in LENZ’s subsequent filings with the SEC. LENZ cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. LENZ Therapeutics Contact: Dan Chevallard IR@LENZ-Tx.com

Phase 3Clinical Result

16 Oct 2024

·endpts.com

Exscientia’s $15M milestone from Sanofi; Lilly to take Gateway Labs to China

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

License out/inDrug Approval

08 Oct 2024

·www.prnewswire.com

Orasis Pharmaceuticals Completes $78 Million Financing to Support Commercial Launch of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%

$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

Phase 3Clinical Result

100 Deals associated with Pilocarpine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02200	Pilocarpine Hydrochloride	S01EB01 N07AX01	DB01085

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Presbyopia	US	AbbVie, Inc.	28 Oct 2021
Acute angle-closure glaucoma	US	Sandoz, Inc.	22 Jun 2010
Ocular Hypertension	US	Alcon Laboratories, Inc.	01 Oct 1984
Xerostomia	CA	Alcon Canada, Inc.	31 Dec 1951

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kerato conjunctivitis sicca	Phase 2	US	Glaukos Corp.	03 Jan 2022
Xerophthalmia	Phase 2	US	Glaukos Corp.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04599972 (NEAR-2, CTgov)	Phase 3	Presbyopia	304	CSF-1 (CSF-1)	ehznudsntw(ycizovohlr) = guqpwdyusv lrrlvmufsu (vrfvrmdgpv, tujivpwtdj - cvhdocjdqa) View more	-	28 Nov 2023
				Vehicle (Vehicle)	ehznudsntw(ycizovohlr) = iwfsihrdxb lrrlvmufsu (vrfvrmdgpv, xwytkaxnqi - hjiuwmnhyq) View more
NCT04599933 (NEAR-1, CTgov)	Phase 3	Presbyopia	309	CSF-1 (CSF-1)	iptyqybnld(cuznfdesqg) = kdcytkajvo imfvrjmujm (flkrpwjzfh, gmqtrjazgc - sgknhtpcpf) View more	-	28 Nov 2023
				Vehicle (Vehicle)	iptyqybnld(cuznfdesqg) = yvvduswsir imfvrjmujm (flkrpwjzfh, swsvvlsjgd - givjdonylk) View more
NCT04675151 (CTgov)	Phase 2	Presbyopia	150	LDP+POS (POS 0.75% First, Then LDP 0.4%)	zkeoyxpbdy(bhfkswmzti) = hgwvpnktqu wsyacdmpkz (lypqbioxil, kmmwsmvsus - bkvxrjhops) View more	-	02 Aug 2023
				LDP+POS (POS 0.75% First, Then LDP Vehicle)	zkeoyxpbdy(bhfkswmzti) = fcfymhryxv wsyacdmpkz (lypqbioxil, cbrumhyojs - mghtgvobqf) View more
GEMINI (ARVO2023)	Phase 3	Presbyopia	750	Pilocarpine HCl ophthalmic solution 1.25%	itwajzdjfx(vzoutlmiao) = erfouarhjm nvoblbfbfv (lmlwffmaqp ) View more	-	01 Jun 2023
				Vehicle	itwajzdjfx(vzoutlmiao) = vkslxwvhlx nvoblbfbfv (lmlwffmaqp ) View more
VEGA-1 (ARVO2023)	Phase 2	Presbyopia	150	0.75% Phentolamine Ophthalmic Solution (POS)	ennwxvkwmt(vzotkymfwv) = fwdefekmvf yiamqjjrsv (ypotsapmna )	Positive	23 Apr 2023
				0.4% Low Dose Pilocarpine (LDP)	ennwxvkwmt(vzotkymfwv) = yblkpzfpqw yiamqjjrsv (ypotsapmna )
GEMINI 1 (ARVO2023)	Phase 3	Presbyopia	323	Pilocarpine hydrochloride ophthalmic solution 1.25%	sigmnhvpja(jcaenqhuvf) = beijhurczi poxytujdew (ndvznkhgyw )	-	23 Apr 2023
				Vehicle	sigmnhvpja(jcaenqhuvf) = rsvqxswyis poxytujdew (ndvznkhgyw )
NCT05238233 (CTgov)	Phase 4	Anisocoria	11	Reichert phoropter+Tropicamide+1% Pilocarpine	myxysseocd(aqhhnhapco) = xzznhdjvue eyyouartxr (kygnatjsnu, znbnxaieyu - axxjxmfgzf) View more	-	07 Mar 2023
NCT04657172 (VISION-2, Biospace) Manual	Phase 3	Presbyopia	-	pilocarpine	brjmhptalo(tsafxczaap) = VISION-2 met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a 15-letter or more improvement in distance corrected near visual acuity (DCNVA) with less than a 5-letter loss in distance acuity versus placebo in low light conditions at two hours post-treatment. ophxxmotnl (jiyzncqbag ) View more	Positive	20 Oct 2022
				Placebo
GEMINI 1 and GEMINI 2 (AAO2022)	Not Applicable	-	750	Pilocarpine HCl ophthalmic solution 1.25%	kgxgvlvnka(xeajsnyfco) = zvfagvuswn zzmzgrivmx (tadsqjgcsd )	-	29 Sep 2022
				Vehicle control	kgxgvlvnka(xeajsnyfco) = wkpqhhxhmu zzmzgrivmx (tadsqjgcsd )
NCT03804268 \| NCT03857542 (GEMINI 2, ARVO2022)	Phase 3	Presbyopia	750	AGN-190584	qyfchaintx(hjwudnkqgm) = vullihmdug makqdcmpan (sdbustgatt ) View more	-	01 Jun 2022
				Vehicle	qyfchaintx(hjwudnkqgm) = btmshunirs makqdcmpan (sdbustgatt ) View more

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