Section 2 knowledge spotlight constant and sustained reductions in Intraocular Strain (IOP), statistically vital (p<0.0001) by means of six months, with clinically significant reductions of 24-30% achieved with a single PAXTRAVA implant
Typically nicely tolerated with no affect on corneal well being noticed
Constant sturdiness of IOP discount and implant bioresorption exhibits potential for repeat dosing with out stacking of implants
Expanded Give attention to Retinal Illness Highlighted on the April 4th Eyecelerator
BEDFORD, Mass., April 06, 2024 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Firm”), a biopharmaceutical firm dedicated to enhancing individuals’s imaginative and prescient and high quality of life by means of the event and commercialization of modern therapies for moist age-related macular degeneration (moist AMD), diabetic retinopathy, and different ailments and circumstances of the attention, at the moment introduced optimistic Section 2 knowledge for PAXTRAVA (travoprost intracameral implant or OTX-TIC) in sufferers with open-angle glaucoma or ocular hypertension (reported collectively as “glaucoma”, under) The info are being introduced by Mark Gallardo, MD through the 2024 American Society of Cataract and Refractive Surgical procedure (ASCRS) Annual Assembly.
“Ocular may be very happy to report optimistic six-month topline outcomes for PAXTRAVA within the Section 2 glaucoma research. We designed the Section 2 scientific trial to judge PAXTRAVA over a number of time factors that we consider are clinically significant, by means of six months. Remark of IOP discount as early as the primary follow-up go to, at 2 weeks, and demonstration of a 24-30% discount in imply IOP by means of six months, with constant and sustained reductions at each timepoint, are on the core of our enthusiasm for these outcomes. That almost all of eyes (81.3%) handled with PAXTRAVA didn’t require further IOP decreasing remedy by means of six months additional helps the power of the info,” mentioned Rabia Gurses Ozden, MD, Chief Medical Officer at Ocular Therapeutix. “As we incorporate these efficacy knowledge, coupled with the expanded security database, into our analysis of subsequent steps for this system, we thank all the sufferers, caregivers and research websites who participated on this Section 2 research.”
Abstract of Knowledge and Findings:
Efficacy: PAXTRAVA 26 µg single implant demonstrated constant IOP management by means of 6 months:
- Statistically vital IOP adjustments from baseline have been noticed for each particular person and imply diurnal measurement at Week 2 (M0.5), Week 6 (M1.5), and Week 12 (M3), in addition to Months 4.5 and 6 (p<0.0001), though no formal statistical testing was prespecified
- Clinically significant imply IOP discount of ~24-30% from baseline noticed over six months
- A majority (81.3%) of handled eyes didn’t require further IOP-lowering remedy by means of 6 months indicating sustained and constant remedy results
Security: PAXTRAVA 26 µg was usually well-tolerated
- No affect on corneal endothelium was noticed at 6 months following a single administration
- Majority of opposed occasions (AEs) have been gentle in severity and usually resolved with topical medical remedy. Most ocular AEs inside 3 days have been deemed associated to the injection process by the investigators. Publish injection AEs noticed (>3 days submit injection process) have been in keeping with the travoprost label. One implant required removing (categorized as a critical opposed occasion), almost certainly as a result of a peri-implantation bacterial an infection, per investigator
- Constant bioresorption of the implant coupled with the sturdy impact seen within the trial suggests redosing can be potential, with out the chance of stacking implants
“I’ve devoted my profession to caring for individuals with glaucoma and the analysis of latest therapies. I’m captivated with PAXTRAVA due to the optimistic, sturdy IOP reductions, accompanied by a great general security profile,” mentioned Mark Gallardo, MD. Dr. Gallardo is a Research Investigator and Glaucoma Specialist at El Paso Eye Surgeons. He’s an lively principal investigator of modern new remedies, having participated in additional than 20 scientific trials over the past 7 years.
“We have been happy to look at that PAXTRAVA usually stays in place on the website of implantation and maintains its kind, that almost all of implants (64.5%) have been considerably or totally bioresorbed at six months and that the implants weren’t noticed to affect the encircling corneal endothelium. Collectively, these options may deal with the compliance problem of day by day eyedrops and allow repeat dosing, with out the chance of stacking, important for the remedy of power illness. The totality of those options makes me optimistic about this product candidate.”
The entire presentation (Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: Outcomes from a Section 2 Scientific Trial) will likely be out there within the Scientific and Medical shows part of the Firm’s investor web site.
Section 2 Research Overview: The PAXTRAVA Section 2 research was designed as a randomized, parallel-group, managed research to judge the protection and efficacy of PAXTRAVA in topics with open-angle glaucoma (“OAG”) or ocular hypertension (“OHT”) and reported collectively as “glaucoma”, per above. Following a normal medicine wash-out, sufferers have been randomized 1:1:1 into one in all three dosing teams (5 µg or 26 µg of PAXTRAVA or DURYSTA® (bimatoprost implant)), dosed in ‘the research eye’ and adopted for frequent assessments by means of the six month evaluation level. As a result of elevations in IOP noticed in seven out of the 16 topics enrolled within the PAXTRAVA 5 μg arm of the trial, the Firm closed enrollment on this arm and continued with the PAXTRAVA 26 μg and DURYSTA arms of the trial. Security and efficacy knowledge introduced at ASCRS and reported on this press launch are primarily based on the 26 µg dosing group, because of this.
The enrolled topics had a imply age of 65 years and had been beforehand handled with a imply of about 1.2 IOP-lowering brokers prior to check entry. The remedy teams have been nicely balanced for key demographics and baseline traits. The first efficacy endpoints included measurement of adjustments in intraocular stress (IOP) at three diurnal measurements (8 AM, 10AM and 4 PM) at weeks 2, 6, 12 and secondary endpoints included measurements in any respect different visits together with 4.5 and 6 months. No formal statistical testing was prespecified within the scientific trial protocol or the statistical evaluation plan. Different assessments included an analysis of the necessity for extra IOP-lowering remedy, adjustments in endothelial depend and central corneal thickness, in addition to an analysis of security for the interval.
Abstract of subsequent steps: Search an end-of-Section 2 assembly with the FDA to finalize growth plans for PAXTRAVA Section 3 trials and transfer to a subsequent technology, business injector that eases initiation of remedy.
Strategic Give attention to Retinal Illness Highlighted on the April 4th Eyecelerator@ASCRS Convention
On Thursday, April 4th, Pravin Dugel, MD, Government Chairman of Ocular Therapeutix introduced on the Eyecelerator@ASCRS convention. “Ocular was more than happy to attach with the Eyecelerator group to share extra about our strategic imaginative and prescient for Ocular as we transition to a retina-focused firm”, mentioned Dr. Dugel. “There are three necessary pillars associated to our Section 3 program for AXPAXLI for moist Age-related Macular Degeneration (moist AMD) that help our transformation to a number one retina firm: promising scientific knowledge, de-risking regulatory pathway, and an expansive market alternative. With our expanded strategic and scientific crew of acknowledged consultants in place to strengthen the Firm’s retinal experience, I consider we’re on a strong path to counterpoint and speed up the AXPAXLI scientific program.”
The entire presentation (Ocular Therapeutix, Evolving into a number one retina firm) will likely be out there within the Occasions and Shows part of the Firm’s investor web site.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical firm dedicated to enhancing individuals’s imaginative and prescient and high quality of life by means of the event and commercialization of modern therapies for moist age-related macular degeneration (moist AMD), diabetic retinopathy, and different ailments and circumstances of the attention. AXPAXLI (axitinib intravitreal implant, also called OTX-TKI), Ocular’s product candidate for retinal illness, is predicated on its ELUTYX
proprietary bioresorbable hydrogel-based formulation know-how. AXPAXLI is at the moment within the first of two deliberate pivotal Section 3 trials for moist AMD, the SOL-1 trial, and a Section 1 scientific trial for the remedy of non-proliferative diabetic retinopathy. The scientific portfolio additionally contains PAXTRAVA
(travoprost intracameral implant, also called OTX-TIC), at the moment in a Section 2 scientific trial for the remedy of major open-angle glaucoma or ocular hypertension.
Ocular’s experience within the formulation, growth and commercialization of modern therapies and the ELUTYX platform supported the event and launch of its first business drug product, DEXTENZA®, an FDA-approved corticosteroid for the remedy of ocular irritation and ache following ophthalmic surgical procedure and ocular itching related to allergic conjunctivitis. ELUTYX can also be the muse for 2 different clinical-stage belongings, OTX-CSI (cyclosporine intracanalicular insert) for the power remedy of dry eye illness and OTX-DED (dexamethasone intracanalicular insert) for the short-term remedy of the indicators and signs of dry eye illness, in addition to a number of preclinical applications.
Comply with us on our web site, LinkedIn or X.
DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. AXPAXLI, PAXTRAVA
, and ELUTYX
and Ocular Therapeutix
are emblems of Ocular Therapeutix, Inc.
DURYSTA® is a registered trademark of Allergan, an AbbVie firm.
The travoprost label may be referenced utilizing the accessdata.fda.gov website
About DEXTENZA
DEXTENZA is FDA-approved for the remedy of ocular irritation and ache following ophthalmic surgical procedure and ocular itching related to allergic conjunctivitis. DEXTENZA is a corticosteroid intracanalicular insert positioned within the punctum, a pure opening within the internal portion of the decrease eyelid, and into the canaliculus, and is designed to ship dexamethasone to the ocular floor for as much as 30 days with out preservatives. DEXTENZA resorbs and exits the nasolacrimal system with out the necessity for removing.
Please see full Prescribing and Security Info on the DEXTENZA web site.
Ahead-Trying Statements:
Any statements on this press launch about future expectations, plans, and prospects for the Firm, together with the event and regulatory standing of the Firm’s product candidates, together with the timing, design, and enrollment of the Firm’s pivotal trials of AXPAXLI (additionally known as OTX-TKI) for the remedy of moist AMD; the Firm’s plans to advance the event of AXPAXLI, PAXTRAVA and its different product candidates; the dimensions of potential markets for its product candidates; the potential utility of any of the Firm’s product candidates; the sufficiency of the Firm’s money sources; and different statements containing the phrases “anticipate”, “consider”, “estimate”, “count on”, “intend”, “objective”, “could”, “may”, “plan”, “predict”, “mission”, “goal”, “potential”, “will”, “would”, “may”, “ought to”, “proceed”, and comparable expressions, represent forward-looking statements throughout the that means of The Personal Securities Litigation Reform Act of 1995. Precise outcomes could differ materially from these indicated by such forward-looking statements because of numerous necessary elements. Such forward-looking statements contain substantial dangers and uncertainties that might trigger the Firm’s preclinical and scientific growth applications, future outcomes, efficiency or achievements to vary considerably from these expressed or implied by the forward-looking statements. Such dangers and uncertainties embrace, amongst others, the timing and prices concerned in commercializing DEXTENZA or any product or product candidate that receives regulatory approval; the flexibility to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the initiation, design, timing, conduct and outcomes of scientific trials, together with the SOL-1 trial, the deliberate SOL-2 trial and the Firm’s different ongoing scientific trials; the chance that the FDA won’t agree with the Firm’s interpretation of the written settlement underneath Particular Protocol Evaluation for the SOL-1 trial; the chance that although the FDA has agreed with the general design of the SOL-1 trial, the FDA could not agree that the info generated by the SOL-1 trial helps potential advertising approval; uncertainty as as to whether the info from earlier scientific trials will likely be predictive of the info of later scientific trials, notably later scientific trials which have a special design or make the most of a special formulation than the sooner trials; availability of information from scientific trials and expectations for regulatory submissions and approvals; the Firm’s scientific method and common growth progress; uncertainties inherent in estimating the Firm’s money runway, future bills and different monetary outcomes, together with its means to fund future operations, together with scientific trials; the Firm’s current indebtedness and the flexibility of the Firm’s collectors to speed up the maturity of such indebtedness upon the prevalence of sure occasions of default; the Firm’s means to enter into strategic alliances or generate further funding on a well timed foundation, on favorable phrases, or in any respect; and different elements mentioned within the “Threat Components” part contained within the Firm’s quarterly and annual experiences on file with the Securities and Change Fee. As well as, the forward-looking statements included on this press launch characterize the Firm’s views as of the date of this press launch. The Firm anticipates that subsequent occasions and developments will trigger the Firm’s views to vary. Nonetheless, whereas the Firm could elect to replace these forward-looking statements sooner or later sooner or later, the Firm particularly disclaims any obligation to take action, whether or not because of new data, future occasions or in any other case, besides as required by legislation. These forward-looking statements shouldn’t be relied upon as representing the Firm’s views as of any date subsequent to the date of this press launch.
Buyers
Ocular Therapeutix, Inc.
Donald Notman
Chief Monetary Officer
dnotman@ocutx.com
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
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