Simple Drops

Imprimis Pharmaceuticals

A line of preservative-free compounded glaucoma agents

inder-paul-singh

Inder Paul Singh, MD

Glaucoma Specialist, The Eye Centers of Racine and Kenosha in Wisconsin

Expert Reviewer

At-a-Glance
  • Preservative-free glaucoma drops in a multidose bottle
  • Six (6) multi-agent combinations of two or more molecules
  • Compounded, multiagent formulations may benefit patients with convenience and cost-savings
  • Poloxamer 407 based vehicle
  • Potency testing performed to confirm consistent amount of each drug delivered

Description

Simple Drops is a portfolio of compounded ocular hypotensive agents that are made preservative-free via a unique bottle design with a one way valve system. The formulations include all four major classes of glaucoma therapy: prostaglandin analogue, β-blocker, carbonic anhydrase inhibitor, and α-adrenergic agonist. Six of the eight formulations are fixed combinations of two or more molecules which can offer patients convenience by reducing the number of bottles and drops used daily and potential cost savings.

When searching for the optimal vehicle, the company analyzed the performance of ingredients in multiple surfactants (including Poloxamer 407) at a variety of pH ranges, temperatures, and humidities to determine a formulation that would maintain stability and potency. In accordance with rules pursuant to 503A compounding pharmacies, Simple Drops are patient-specific formulations and meet US Pharmacopeia (USP) <795> and <797> guidelines & Pharmacy Compounding Accreditation Board (PCAB) requirements that govern quality and sterility. In fact, Imprimis goes beyond 503A pharmacy requirements and tests each batch for potency, sterility, and endotoxins. By obtaining Simple Drops directly from Imprimis, patients are guaranteed a consistent formulation, bottle appearance, and drop flow which could otherwise change without notice if pharmacies switch between generic brands.

Formulations Molecules Concentration
LAT Latanoprost 0.005%
DOR Dorzolamide 2%
BRIM-DOR Brimonidine and dorzolamide (0.15/2)%
DOR-TIM Dorzolamide and timolol (2/0.5)%
TIM-LAT Timolol and latanoprost (0.5/0.005)%
TIM-BRIM-DOR Timolol, brimonidine, and dorzolamide (0.5/0.15/2)%
TIM-DOR-LAT Timolol, dorzolamide, and latanoprost (0.5/2/0.005)%
TIM-BRIM-DOR-LAT Timolol, brimonidine, dorzolamide, and latanoprost (0.5/0.15/2/0.005)%

Beyond Convenience

The issues of adherence and compliance with prescribed treatments are often cited as a concern for patients’ long-term success with glaucoma management1,2 especially as elderly patients with dexterity problems, poor hand-eye coordination, and faltering memory pose a broad set of challenges.

According to data from 14,000 patients in the Glaucoma Adherence and Persistency Study, as few as 10% of those prescribed glaucoma drops were persistent with therapy without gaps over the following year.3 Cost, dose frequency, and forgetfulness are among the most commonly reported factors for noncompliance.4 In one study, nearly 45% of patients who knew they were being monitored by an electronic device followed their drop schedule less than 75% of the time.5 Studies have also demonstrated fluctuating intraocular pressures can be a risk factor for progression, regardless of the mean IOP. Therefore, if patients are not compliant with their drop regimen, there is a higher likelihood of fluctuating pressures which could result in higher chance of visual field progression.6

Considering as many as 40% of glaucoma patients need more than one hypotensive agent to adequately control IOP,7 combination drugs offer convenience for patients who may only need to instill one drop twice a day instead of remembering to administer multiple separate topical medications during the day. Furthermore, multiagent formulations avoid the washout effect resulting from hasty instillation of consecutive drops. While several combination glaucoma therapies are available, Simple Drops is on a shortlist of options for preservative-free combined formulations.

Although patients typically have to pay out of pocket because most insurance companies do not cover compounded topical medications, potential cost-savings of compounding and combined medications may make the total expenditure less.

The simple drops impact: The Patients' Perspective

Watch the videos below to hear seven patients under the care of Paul Singh, MD, candidly share how Simple Drops has improved their quality of life, helped maintain or lower their intraocular pressures, and in some cases avoid surgery.

"It’s much more convenient. It’s so easy."

A 45-year-old female with advanced glaucoma taking Combigan (Allergan), Azopt (Alcon), and Travatan (Alcon) was at target IOP but complained that she “can’t take all the medications forever.” In the interim before her Xen Gel Stent (Allergan) surgery date, she was switched to Tim-Brim-Dor and stopped PGA. On the Simple Drops regimen, the patient’s IOP measurements remained at target for two follow up exams. She was satisfied with the dosing regimen and elected to forgo surgery.

+ Read case study

"My eyes are better, my vision is better, and my... anxiety level has dropped."

Because of variations in drop volume in his previous medications, this patient was constantly worried about administering the correct amount and running out of medications. As he explains, switching to combined three-in-one and four-in-one formulations had a remarkable impact on his quality of life and his IOP measurements remained stable at 15 mmHg.

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"I find it more convenient to use the one bottle than to have to use all three."

A 72-year-old male with advanced open angle glaucoma has IOP measurements between 13 and 14 mmHg on a regimen of Alphagan (Allergan), Timolol, Azopt (Alcon), and Latanoprost. After complaining about the time he spent each day administering drops he was switched to Tim-Brim-Dor and Lat. Pressures maintained at 13 mmHg and he stated that the convenience had improved his quality of life.

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"It’s much easier to take...just that one bottle, and it’s easier to go in [the eye] too."

A 53-year-old African American male with moderate open angle glaucoma who had previously undergone SLT was using Simbrinza (Alcon), Lumigan (Allergan), and Timolol with pressuring ranging from the upper teens to low 20s. He achieved target in the middle teens after switching his regimen to Tim-Brim-Dor in mornings and Tim-Brim-Dor-Lat at night.

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"More comfortable… less sting and no burning [compared to previous drop]"

This 42-year-old male has a history of secondary glaucoma from diabetic related neovascular glaucoma (NVG) and macular edema. After developing NVG, his pressures had begun fluctuating from 20 mmHg to just over 30 mmHg while taking Combigan (Allergan). After switching to Tim-Brim-Dor, pressures lowered approximately 10 mmHg to the upper teens.

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"One drop instead of two different ones"

An 83-year-old with moderate glaucoma had pressures in the mid 20s while taking Cosopt (Merck) and Alphagan (Allergan) and reported difficulty remembering drops and spacing them out as recommended. After four weeks on Tim-Brom-Dor his IOP measured 16 mmHg and 17 mmHg at two separate visits. In this video, he explains that the drops felt comfortable in his eye and that the combined regimen was preferable.

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"Easy to use and my eye is more comfortable"

A 42-year-old male with a history of secondary glaucoma from angle recession glaucoma and a trabeculectomy was taking Alphagan (Allergan), Cosopt (Merck), and Lumigan (Allergan). For years, his pressures had fluctuated in the 20s until he began using Tim-Brim-Dor in mornings and Tim-Brim-Dor-Lat at night. Pressures came down to 15 mmHg and the patient stated his eye feels "better."

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Testimonials

Simple Drops benefits my patients in four big ways. 1.) When on multiple medications, it spares them the preservatives of multiple drops. 2.) They get preservative-free versions for less cost than they would if they bought them separately. 3.) The drops work better in my experience because they aren't washing out the first medicine with the second or third. 4.) It’s more convenient to get all the meds in with one drop. Convenience, price, efficacy, and sparing the eye of preservatives are accomplished easily with Simple Drops, whether treating glaucoma, postoperative drops, or countless other common eye conditions.

Ahad Mahootchi, MD

The Eye Clinic of Florida, Zephyrhills, FL

Simple Drops has improved the quality of life for many of my glaucoma patients. Compliance is enhanced since their medication burden is reduced from sometimes 14 drops down to 4 drops per day. Medication costs remain the same or decrease depending on the patient's pharmacy benefit plan and copays. It is more convenient for patients since the drops are mailed directly to their house and they no longer need to wait in line at their pharmacy. The quality of patients' ocular surface is improved with Simple Drops since the product is preservative-free. Many patients report less ocular irritation on Simple Drops. This product has made it much easier for me to implement maximal medical therapy for my glaucoma patients in a convenient, patient-friendly, and cost-effective manner.

H. George Tanaka, MD

California Pacific Medical Center, San Francisco, CA

For glaucoma management, I want to confidently prescribe uniform formulations that are preservative free and cost-effective. With Simple Drops, I’m not surprised by fluctuating outcomes or distracted by having to manage other problems for the glaucoma patient. Depending on the IOP desired I will typically prescribe the Lat (latanoprost) drop formulation administered at bedtime or Tim-Lat (timolol and latanoprost), administered once a day. For my office, Simple Drops by Imprimis Pharmaceuticals provides the benefits of a brand quality formulation with the cost savings of a generic formulation.

Agustin Gonzalez, OD, FAAO, ABCMO

Eye & Vision, Richardson, TX

Preservative-Free Bottle Technology

Delivery of a preservative-free solution is made possible by a unique bottle with a one way valve system that ensures no contaminated liquid can be reintroduced into the container after a drop has been dispensed. Intake of air to counterbalance egress of liquid takes place via a separate venting system with a silicone membrane. This bottle also has an easy-open, tamper-evident lid.

One Way Valve System

Prevent the risk of contamination



Controlled Flow

Active pressure, not gravity, initiates drop



Blue Tip

Focal point to help patients align the drop trajectory




One Way Valve System

Prevent the risk of contamination

Controlled Flow

Active pressure, not gravity, initiates drop

Blue Tip

Focal point to help patients align the drop trajectory


From Your Peers

Skeptics accurately point out the lesser amount of data available for compounded glaucoma therapies than for currently available brand-name products, but the former do have potential advantages."

Glaucoma Today, October 2017

Lauren Seo and Nathan Radcliffe, MD

READ ARTICLE »

References

1. Muir KW, Lee PP. Glaucoma Medication Adherence: Room for Improvement in Both Performance and Measurement. Archives of ophthalmology. 2011;129(2):243-245. doi:10.1001/archophthalmol.2010.351.

2. Virani S, Rewri P, Dhar M. Difficulties with self instillation of eye drops and its impact on intraocular pressure in glaucoma patients. J Clin Ophthalmol Res 2015;3:87-90.

3. Friedman DS, Quigley HA, Gelb L, et al. Using pharmacy claims data to study adherence to glaucoma medications: methodology and findings of the Glaucoma Adherence and Persistency Study (GAPS). Invest Ophthalmol Vis Sci. 2007 Nov;48(11):5052-7.

4. Patel SC, Spaeth GL. Compliance in patients prescribed eyedrops for glaucoma. Ophthalmic Surg. 1995 May-Jun;26(3):233-6.

5. Okeke CO, Quigley HA, Jampel HD, et al. Adherence with Topical Glaucoma Medication Monitored Electronically: The Travatan Dosing Aid Study. Ophthalmology. 2009;116:191–9.

6. Caprioli J, Coleman AL. Intraocular pressure fluctuation a risk factor for visual field progression at low intraocular pressures in the advanced glaucoma intervention study. Ophthalmology. 2008 Jul;115(7):1123-1129.e3. Epub 2008 Feb 20

7. Preservative-free Glaucoma Medications. Glaucoma Research Foundation website. https://www.glaucoma.org/treatment/preservative-free-glaucoma-medications.php. Accessed March 12, 2018

Financial disclosures: Inder Paul Singh, MD, is a consultant to Imprimis Pharmaceuticals, Inc.