Glance Editorial Team

 assessed the impact of Nanodropper Bottle Adaptor  in 

reducing the number of dispensed eye drops

Nanodropper, Inc. is a micro-volume ophthalmic delivery device company focused on providing solutions to adherence barriers for chronic ocular disease management.

According to the company, its products and educational content are designed to help patients with issues like vision insurance and eye care appointments, with the primary goal of reducing financial burdens.

As Nanodropper’s flagship product, the adapter is currently the first and only FDA-listed, volume-reducing adaptor for eye drop bottles, with a “one-size-fits-most” compatibility.

, the adaptor is sold for $15.99. The medical device can also be found at 

Investigators sought to determine the eye drop volume and total number of dispensed eye drops when using the Nannodropper adaptor versus drops dispensed from stock bottles.

The purpose was to potentially limit ocular toxicity of the drops and prolong bottle use, according to the study.

They first selected six topical ocular hypotensive medications— five solutions and one suspension— as well as one steroid (suspension) and two artificial tear emulsions.

The investigators then determined the mass per 10 drops, with and without the adaptor, using an analytical balance until all nine bottles were emptied.

They used the calculated density of each bottle to determine their density. Finally, the average drop volume and number of drops per bottle for each of the nine medications were compared (with / without the adaptor) using paired t-testing.

The adaptor-delivered drops were 62.1% smaller than those administered from the nine medications, translating to a 2.6-fold increase in the number of drops in a 2.5 milliliter bottle:

Further, the mean volume of the Nanodropper drops was 15.1 ± 1.0 μL, p<0.0001 compared to 39.8 ± 2.1 μL for stock bottle drops.

The study authors concluded that the use of the Nanodropper adaptor results in a significant reduction in drop volume as well as an increase in the overall number of drops dispensed when compared to stock bottle-delivered drops.

However, they also cautioned that further research is needed to “elucidate the clinical impact of utilizing decreased drop volume with direct comparison to current standards of care.”

While it’s noted that further study is needed in exploring the effectiveness of Nanodropper’s adaptor with reducing drop volume, previous research has also assessed its use in a variety of clinical settings.

Research tests the use of the Nanodropper Bottle Adaptor for volume reduction compared to standard eye drops.

Nanodropper

How effective is Nanodropper in reducing topical medication waste?

 Proceedings of the National Academy of Sciences (PNAS

) suggests that neuroplasticity in certain white matter pathways may be induced by vision restoration surgery despite the age of the patient.

In a longitudinal study, researchers followed 19 cataract patients (13 male, 6 female) from Uttar Pradesh, India, between the ages of 7 to 16 years to track visual acuity (VA) performance over time.

The mean age at time of surgery was 12.34 years (±3.69). All patients had dense bilateral cataracts prior to 1 year of age and received IOL implants with additional refractive correction.

Over the course of the study, patients’ VA was measured an average of 7.9 ± 3.9 times.

In the VA test, patients were asked to identify various stimuli at 40 cm. They also performed facial discrimination tests an average of 4.2 ± 2.0 times, in which they were asked to identify faces and “nonface objects.”

MRI scans were also performed on each patient.

Patients experienced the most improvement in performance in the days immediately following surgery, and patients who received surgery at a younger age experienced greater improvement than those who received surgery later.

However, the study authors noted, “while there is no evidence that time of surgery affects the [VA] improvement for these patients, face discrimination depends on a closing window of neural plasticity whereby surgery at a later age reduces the behavioral improvement.”

Neuroplasticity can be defined as the ability of the brain to form synaptic connections, which is usually considered in the context of learning or injury recovery. The brain can develop at different rates, and the 10 major pathways that determine visual processing were divided by the study authors into early-visual, late-visual, and non-visual pathways.

Early-visual pathways are called such because they develop earlier and are subject to a so-called sensitive period for development.

The study authors hypothesized that because of this sensitive period, the window for pathway development would have closed despite the later onset of visual input.

Using MRI scans and 80 age-matched controls, the researchers analyzed the difference between age-related maturation effects on white matter pathways compared to the changes in those pathways following visual recovery.

While VA improved following surgery, researchers found no evidence that these improvements were linked to changes in any particular white matter pathways.

Patients who received surgery earlier in life were more likely to experience greater improvement in face recognition; these improvements were also linked to specific changes in white matter pathways following surgery.

Specifically, the structural changes occurred in late-visual pathways: the inferior fronto-occipital fasciculus (IFOF), the superior longitudinal fasciculus (SLF), the inferior longitudinal fasciculus (ILF), and the posterior forceps (also referred to as forceps major) of the corpus callosum.

Sight restoration, even in later adolescence, can kickstart the neuroplasticity of visual pathways.

While not all white matter pathways are affected, the “sensitive period” for vision development should not be considered a major barrier to treatment for patients who have “aged out” of it since the restoration of the visual pathway can still result in substantial neural and behavioral gains.

“Window of plasticity” for some visual tasks extends further than previous research has suggested.

Anatomical brain changes noted in patients with restored vision

Eyes On Eyecare has successfully launched the first series with the four-part dry eye implementation program.

Implementation Pathways to Dry Eye Practice Success

 is designed for eyecare professionals (ECPs) looking to immediately grow their dry eye practices.

The program consists of four series that focus on dry eye solutions, diagnostics, in-office procedures, protocols for refractive surgery patients, and advanced ocular surface therapeutics.

The first in this inaugural series—Getting Started with Eyecare Solutions—  drew 650 attendees who consumed over 750 hours of education on how to start and grow a dry eye speciality practice.

In total, the course resulted in 1,300 leads for sponsoring organizations and 50 direct product inquiries.

Attendees of Series 1 shared a fresh understanding of the importance of creating a process that includes dry eye symptom screening with a validated questionnaire, thoughtful diagnostic testing that provides actionable data, and a treatment plan that includes the most effective over-the-counter (OTC) products, prescription therapy, and in-office procedures.

On Friday, June 2, 2023, the series will continue with 

Next Steps with Diagnostics and In-Office Procedures

 from 7:30am-1:20pm PT /10:30am-4:20 pm ET.

Session 2 will focus on educating ECPs on the latest research and strategies to accurately diagnose dry eye patients at the earliest stages.

Designed for serious practitioners, attendees are expected to show up to the courses with practical questions and implement the skills and knowledge gained in the course.

How can I sign up for these next 3 sessions?

Each 5-hour workshop will focus on a specific aspect of DED management, including:

 Next Steps With Diagnostics and In-Office Procedures (Friday, June 2)

 Dry Eye Optimization for Lens and Refractive Surgery Patients (Saturday, July 8)

 Advanced Management With Ocular Surface Therapeutics (Saturday, July 22)

Gotcha … so how is this different from other dry eye courses at EoE??

, held in February, is the largest virtual event dedicated exclusively to dry eye disease (DED) education for a broad audience of MDs, ODs, and technicians.

 is a series of intimate practical workshops targeted to eyecare professionals serious about investing in and growing their practices. Rather than CE, ECPs can expect specific and practical business technical training on how to take their dry eye practices to the next level.

ECPs and their staff can attend one or all sessions, as each track is designed to create success in a specific area—from which diagnostics to invest in to how to treat advanced disease states.

Eyes On Eyecare successfully launches the first series with the four-part dry eye implementation program.

Eyes On Eyecare

Inaugural dry eye forum kicks off summer series

 in its phase 2b ODYSSEY trial on CLS-AX (axitinib injectable suspension) for suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD).

CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI) that originated as an oral tablet formulation widely used for the treatment of advanced renal cell carcinoma.

It works by targeting vascular endothelial growth factor (VEGF) and directly blocking VEGF receptors-1, -2, and -3.

In wet AMD, CLS-AX is being delivered via Clearside’s patented suprachoroidal space (SCS) Microinjector.

The company’s patent-protected, proprietary suprachoroidal space (SCS) injection platform includes a syringe, custom-designed hub, and two 30-gauge hollow microneedles for suprachoroidal administration.

The treatment approach provides access to the back of the eye and delivers drugs into the suprachoroidal space (enabling targeted delivery and reducing / eliminating potential toxic effects).

 from the phase 1/2a OASIS clinical trial reported CLS-AX to be well-tolerated and demonstrated a favorable safety profile.

The randomized, double-masked, parallel-group, active-controlled, multicenter phase 2b ODYSSEY trial is enrolling 60 patients diagnosed with wet AMD and randomized 2:1 between CLS-AX and aflibercept arms.

 for a brief rundown on patient criteria.

Two-thirds (40) of patients will receive CLS-AX and 20 patients will be administered aflibercept.

Participants in both arms will receive three monthly 2 mg loading doses of aflibercept while participants in the CLS-AX arm will be administered one loading dose of 1.0 mg CLS-AX at the same visit as the baseline dose of aflibercept.

After that, patients will receive (in the CLS-AX arm) CLS-AX at least every 24 weeks, unless disease activity assessment indicates the need for supplemental treatment.

Subsequently, CLS-AX might be administered 12 weeks after the last dose; however, if less than 12 weeks, aflibercept may be given.

For patients in the aflibercept arm, they will be administered aflibercept on a fixed-dosing regimen every 8 weeks.

The primary outcome includes a mean change in best-corrected visual acuity (BCVA) from baseline to Week 36.

Other changes in visual function and ocular anatomy

 for the criteria; based on measurement changes due to wet AMD)

Treatment burden, measured by total injections through Week 36.

Per CEO George Lasezkay, PharmD, JD, the company intends to use the criteria and outcome measures of the ODYSSEY trial to design a potential phase 3 program for CLS-AX.

Investigators are targeting 30 U.S.-based clinical trial sites for enrollment; the company plans to release topline data by Q3 2024.

According to Clearside, its suprachoroidal injectable suspension of CLS-AX has the potential for prolonged duration and target delivery to the affected tissue layers (while minimizing drug exposure to the front of the eye) in wet AMD.

CLS-AX is being assessed for suprachoroidal delivery using the company’s proprietary CSC Microinjector.

Clearside Biomedical

Enrollment opens for Clearside Biomedical's ODYSSEY phase 2b trial for wet AMD

 announced it has reached target enrollment

 (48 patients) for its SLO-RP phase 1/2 clinical trial assessing NPI-001 tablets for the treatment of retinitis pigmentosa (RP) associated with Usher syndrome (USH).

Nacuity Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing targeted therapies for oxidative stress.

, the company currently has several highly differentiated clinical programs for RP, cataract, and cystinosis.

Granted Orphan Drug status by the FDA, NPI-001 is a proprietary, Good Manufacturing Process (GMP) formulation of N-acetylcysteine amide (NACA) tablets designed to block oxidative stress associated with RP and other blinding eye diseases.

The tablet is developed to protect photoreceptor cones within the eye from oxidative damage via boosting glutathione (the strongest known endogenous antioxidant within the body) in order to prevent chemically-aggressive oxygen molecules from causing damage to ocular tissues.

The randomized, placebo-controlled, multicenter, double-masked, dose-escalation phase 1/2 trial (

) is called the Safety and Efficacy of NPI-001 Tablets versus PLacebO for Treatment of Retinitis Pigmentosa Associated with Usher syndrome (SLO-RP).

Divided into two phases, the trial is assessing the use of a 250 mg oral NPI-001 tablet twice a day (BID) compared to oral placebo tablets (BID) for 24 months in 

 (age 18+ years) diagnosed with RP associated with USH at four trial sites located in Australia.


Following the 24-month period, treatment will be extended for interested patients; according to the company, all eligible patients have chosen to continue.

Primary outcomes include the change from baseline for retinal sensitivity, as determined via microperimetry of active vs placebo, for 24 months.

This will also be evaluated for the extension period.

According to Halden Conner, chairman, CEO, and co-founder of Nacuity, the company is looking forward to “sharing results from an interim analysis including efficacy data by year end 2023.”

, the study is expected to be completed by January 2025. Stay tuned for updates in the meantime!

The phase 1/2 study is assessing NPI-001, developed to block oxidative stress associated with RP and other blinding eye diseases.

Nacuity Pharmaceuticals

Target enrollment achieved in trial for RP associated with Usher syndrome

 from its phase 1/2 trial assessing the safety and efficacy of CTx-PDE6B as a gene therapy treatment for retinitis pigmentosa (RP) caused by bi-allelic mutations in the PDE6B gene (PDE6B-associated RP).

Based in Paris, France, Coave Therapeutics is a clinical-stage biotechnology company developing gene therapies for rare ocular and central nervous system (CNS) diseases.

The company’s adenovirus associated virus (AAV) vector-Ligand Conjugates platform (ALIGATER) is a proprietary technology that allows for targeted delivery, enhanced transduction, and tissue distribution in order to improve the efficacy of its advanced gene therapies.

CTx-PDE6B (AAV2/5-hPDE6B or HORA-PDE6B) is a clinical-stage AAV5-based gene therapy designed to transport a non-mutated copy of the functional human PDE6B gene into the subretinal space. In turn, there is a rapid induction of transgene expression and synthesis of functional PDE6B proteins into the rods and cones of the retina.

By supplying the functional missing protein, the gene therapy is intended to stabilize or block retinal degeneration in patients who are PDE6B deficient.

The monocentric, open-label, dose-ranging, non-randomized, interventional phase 1/2 clinical trial (

) is assessing CTx-PDE6B as a unilateral, subretinal administration in 17 patients (18+ years of age) divided into four cohorts.

To date, CTx-PDE6B has been administered in two ascending doses.

Each cohort includes varying doses of CTx-PDE6B:

Cohort 1 → Low dose (dose-escalation performed following Data and Safety Monitoring Committee [DSMC] assessment)

Cohort 2a → Medium dose (confirmatory dose determined following DSMC assessment)

Cohort 2b → High dose (confirmatory dose determined following DSMC assessment)

Cohort 3 → High dose (confirmatory cohort)

The primary outcome measures include the occurrence of ocular and non-ocular adverse events (AEs) over the 12-month time period and followed by 4 years of follow-up.

Secondary outcomes include improvement in:

Visual function (assessed via mobility test)

Visual fields (assessed via visual fields measurements)

Visual function (assessed via reading speed)

Quality of life [QoL] (measured by the National Eye Institute Visual Function Questionnaire)

According to the company, following the 12-month study period, both doses were well-tolerated (n = 17).

A patient subgroup (n = 6) who received a higher dose with a less advanced stage of RP  exhibited positive efficacy results based on retinal anatomical evaluation via optical coherence tomography (OCT) and across all five endpoints:

A significant favorable progression of sensitivity for the four central loci within the retina was noted in treated (vs untreated) eyes.

Further, the company reported that the full-field sensitivity test for blue light evaluating rod function illustrated improvement in light perception threshold that favored treated eyes—an observation noted as clinically meaningful.

According to Coave CEO Rodolphe Clerval: ““These initial findings provide strong support for expanding this Phase I/II study to include patients with less advanced disease while we begin our preparations for a registrational trial with CTx-PDE6B.”

Gene therapy candidate targets treatment for a rare form of retinitis pigmentosa: PDE6B RP.

Coave Therapeutics

Positive 12-month data reported in Coave's ongoing RP phase 1/2 trial

 of the optomap ultra-widefield (UWF) retinal imaging modalities available with the company’s California FA device.

Optos is a retinal imaging company—and subsidiary of Nikon Corporation—developing integrated UWF high-resolution digital images (dubbed “optomap”) with image-guided optical coherence tomography (OCT).

The company’s devices target early detection, management, and treatment of retinal disorders and diseases, including retinal detachments and tears, glaucoma, diabetic retinopathy (DR), and age-related macular degeneration (AMD).

 features an innovative optical design that produces a 200° single-capture retinal image in less than half a second.

The device is currently available in multiple image modality options, including:

Central pole (detailed view of the macula)

Stereo (Image pairing for optic disc with retinal evaluation)

The California also includes a green laser AF that shows macula and optic nerve detail; a browser-based image review for easier, HIPAA-compliant access to data from any connected computer or tablet; and an auto-montage that combines an optomap series into a single image that displays up to 97% of the retina.

 for a virtual showroom to learn more details about the device.

The latest addition to the image options is the first UWF color red/green/blue (rgb) image, designed to be captured simultaneously to the optomap 

option produces four images in a single capture (

, sensory red-free, and choroidal) and autofluorescence.

 to take a look at a pathology and case example that uses California's 

Any expert feedback on the new addition yet?

 at this year’s American Society of Cataract and Refractive Surgery (ASCRS) meeting, three ophthalmologists shared their feedback.

Latest feature expands capabilities of the company’s California FA retinal imaging medical device.

Optos

Optos releases new UWF color image modality for retinal disease

 led by a team of researchers from Spain performed a literature review to evaluate the link between physical activity and symptoms of dry eye disease (DED).

In this meta-analysis study, investigators reviewed 16 papers from the PubMed and Web of Science databases to determine the association between exercise and DED symptoms.

These papers evaluated dry eye-associated signs, such as changes in tear volume, osmolarity, and/or biochemical composition, as well as dry eye subjective symptoms in patients primarily between the ages of 20 and 70 (with one paper assessing pediatrics and an inclusion of a small number of patients over the age of 70 in the remaining papers).

Of the 16 papers, eight measured the changes in dry eye signs after a single, acute session of aerobic exercise, while the other eight studies measured the changes in dry eye symptoms in relation to the long-term practice of physical activity.

In general across the studies, it was shown that after performing a short period of high to maximal-intensity aerobic exercise:

Tear breakup time (TBUT) did not change or was prolonged

However, the length of these responses and if they were maintained after repeated bouts of exercise is still unknown.

Interestingly, a potential link between osmolarity and oxygen bioavailability was identified.

The study authors noted that the increase in tear film osmolarity in response to high or maximal-intensity exercise was lower after supplemental oxygen administration and in individuals with high maximal oxygen uptake.

Additionally, investigators hypothesized that during physical activity, the simultaneous activity of both autonomic divisions of the nervous system on the lacrimal gland could influence the increased tear volume and/or its differential in composition after exercise.

Researchers observed that habitual physical activity led to a long-term adaptation of the autonomic nervous system, increasing the so-called “parasympathetic tone.”

They hypothesized that higher basal tonic activity of the parasympathetic nervous system could improve both lacrimal gland secretion and the physiological function of the meibomian glands.

This literature review shows strong evidence to suggest that physical activity could act as a modulatory stimulus to maintain the proper functionality of the tear film while possibly alleviating the signs and symptoms of DED.

Meta-analysis shows the positive impact of long-term physical activity on DED symptoms.

Physical activity may relieve DED symptoms

New federal legislation, supported by the American Optometric Association (AOA) and the Health Care Alliance for Patient Safety (HCAPS), is calling for a ban on online retailers’ use of automated robocalls to verify contact lens prescription.

Contact lenses are regulated under the FDA as 

medical devices requiring an optometrist’s prescription and professional oversight.

However, online lens retailers may allow consumers to purchase such lenses with expired prescriptions or different brands / types of lenses than initially prescribed by an eye doctor.

, such retailers may use robocalls to use the “passage verification” provision set by the  

 (FCLCA)—where doctors have an 8-hour turnaround time to respond before a prescription is verified automatically—to their advantage.

Now give me a rundown on this legislation.

Introduced into the U.S. House on April 20, 2023, 

H.R. 2748 Contact Lens Prescription Modernization Act

 proposes revising the requirements for prescription verification of contact lens purchases.

Specifically, “online sellers of prescription contact lenses must provide consumers with a method to transmit a digital copy of their prescriptions to such sellers,” the bill states.

Further, the bill proposes that online sellers must also encrypt patients’ protected health information that is sent by email, as well as prohibits any prescription contact lens seller from using robocalls to verify a patient’s prescription.

Is this the first time the bill’s been introduced?

It’s actually not. Back in October 2020, the legislation (then called 

The Contact Lens Rule Modernization Act (S. 4613)

 earned bipartisan support and was noted as the AOA’s “largest advocacy campaign in recent history.”

However, it did not gain enough momentum to pass in the House or Senate.

Patient safety concerns over online retailers’ use of automated robocalls and manipulation of verification requirements

Require retailers to use direct communication (email, live phone calls, fax) to confirm prescription accuracy

Require retailers to offer a HIPAA-complaint method to allow patients to upload an electronic copy of their prescription.

U.S. Representatives Michael Burgess, MD (R-Texas) and Lisa Blunt Rochester (D-Del), who introduced the bill in both the 116th and 117th sessions of Congress, released a 

The [bill] prohibits robocalls for contact lens prescription verifications and extends HIPAA protections to correspondence between a patient and an online seller,” stated Burgess. “This bill will maintain consumers’ freedom while ensuring that physicians can safely verify their patients’ prescriptions.”

The AOA is encouraging support for the bill from the eyecare community to “close loopholes in the verification system and restore common sense health and safety consideration.”

” advocacy event during the 2023 annual Optometry’s Meeting (June 21-24, 2023) in Washington, D.C.

: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.

Bipartisan legislation seeks to address patient safety concerns and crack down on online retailer federal requirements.

HEADLINES

Anatomical brain changes noted in patients with restored vision

Inaugural dry eye forum kicks off summer series

Enrollment opens for Clearside Biomedical's ODYSSEY phase 2b trial for wet AMD

FEATURED

How effective is Nanodropper in reducing topical medication waste?

TRENDING

Business

Norlase secures $11 million following ECHO approval

Ray Therapeutics secures $100 million in funding for optogenetic gene therapy programs

Graybug Vision and Mireca terminate IRD partnership

Alimera purchases US commercial rights to YUTIQ

Research

Anatomical brain changes noted in patients with restored vision

Physical activity may relieve DED symptoms

Two-year data on OMNI Surgical System shows promise for POAG patients

Physical chemistry mechanism may fight against AMD

Pipeline

Enrollment opens for Clearside Biomedical's ODYSSEY phase 2b trial for wet AMD

Target enrollment achieved in trial for RP associated with Usher syndrome

Positive 12-month data reported in Coave's ongoing RP phase 1/2 trial

4DMT reports positive interim data from phase 1/2 wet AMD trial

Products

How effective is Nanodropper in reducing topical medication waste?

Optos releases new UWF color image modality for retinal disease

iHealthScreen submits AI-based AMD screening tool to FDA for 510(k) clearance

CDC reports new fatalities, vision loss in eye drop recall

Legal

Proposed bill bans contact lens prescription robocalls

Amgen purchase of Horizon delayed after FTC lawsuit

AOA responds to Florida's 'Not a doctor' legislation

FDA warns against use of unapproved amniotic fluid eye drops

Archives

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Events

Inaugural dry eye forum kicks off summer series

GMAC launches myopia awareness summer campaign

Euclid and Visionary Optics to host nationwide specialty contact lens forums

Registration opens for Eyes On Glaucoma