Biotech startup Ocubio has launched its first product in an anticipated pipeline of eyecare solutions: the Qualified Autologous Serum Eye Drops (qASED).
How exciting! But first: a rundown on this company.
Stemming from the University of Miami School of Medicine’s Bascom Palmer Eye Institute, Ocubio was founded in 2018 with one main goal: to utilize “the regenerative potential of personalized therapies for ocular health.”
In other words: The company is focused on spearheading the development of personalized ocular therapeutics for complex eye diseases.
And its founder: Alfonso L. Sabater, MD, PhD, an associate professor of Clinical Ophthalmology at Bascom Palmer, as well as the company’s chief vision officer.
- Notably: Dr. Sabater is referred to as a surgeon-scientist known for performing the first successful corneal gene therapy.
And what’s the basis for its research?
To start: The company received phase 1 and 2 grant funding (totaling $900k) from the U.S. Department of Defense’s Small Business Technology Transfer (STTR) awards.
Plus: Ocubio was also granted an exclusive license for a proprietary manufacturing protocol (originally developed at Bascom Palmer) designed to “ensure consistency, high quality, and remarkable ocular regenerative properties,” according to the company.
Under this license and using the protocol, the company developed Ophthalmic Biologic Solution (OB-1)—an allogeneic and standardized human platelet lysate eye drop.
- Its ocular target: dry eye disease (DED)
- And also potentially for conditions commonly associated with DED, including autoimmune diseases
What’s the difference between OB-1 and qASED?
OB-1 is reportedly still under clinical development.
Some background on it: The eye drop incorporates elements found in blood plasma—growth factors, proteins, and anti-inflammatory agents, for example—to support both ocular surface health and natural healing processes.
- Translation: The drop provides a “personalized treatment" based on a patient’s own blood serum (which isn’t exactly a new phenomena for ocular surface treatment).
And how does this compare to qASED?
qASED is reported to be formulated to mimic the natural composition of tears, supplying key nutrients and growth factors to the ocular surface.
Compared to standard autologous serum eye drops (ASEDs): These are described as a “high-quality version,” due in part to the use of that aforementioned proprietary manufacturing protocol
- Editor’s note: The company provided no additional details on this protocol to Glance at the time of publication.
And storage-wise: The drops can either be refrigerated at 36° to 46° or at room temperature up to 77°F during use for up to 7 days—if unopened, the bottles should be frozen (-13° to 5°F).
Any preservatives in them?
None. The drops are stored in sterile multidose preservative-free (PF) bottles.
Notably: Ocubio stated it performs microbial filtration and sterility testing on each batch of qASED.
Are they approved by the FDA?
No, they’re not. As they are not evaluated by the federal agency, Ocubio stated that the product “is provided under the discretion of the prescribing physician.”
So does that mean they’re being used under investigational use?
No again. The reason: Because ASEDs are considered a “blood product”—and not a pharmaceuetical—they are not regulated by the FDA.
In fact, as recent research has noted: There’s currently no federal protocol or requirements in place for the use (or preparation) of such eye drops—although regulations do exist in some states.
Although it’s important to note: ASEDs are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER)—which manages blood intended for transfusions and any derivatives—during the collection process of a patient's blood.
And in the case of Ocubio?
qASED is reported to utilize a “FDA-certified blood center” (in other words: CBER-regulated) that ensures each batch meets quality control protocols.
Beyond this: If the company were looking to develop a mass-producable serum drop (in lieu of the personalized qASED currently in its inventory), Ocubio would need to obtain FDA approval.
What that process would entail: Ocubio would need to submit a new drug application (NDA) to the federal agency—and have it approved.
And that would require clinical trial data, right?
Indeed it would.
According to the startup, its investigational OB-1 drops are undergoing safety and tolerability evaluation in a phase 1 clinical trial among DED patients—with a phase 2 multicenter study expected to further analyze the drops’ safety and efficacy.
- Editor’s note: Glance reached out to Ocubio to confirm the intent behind its development of these OB-1 drops—as of May 1, we have not received a response.
Back to qASED … can patients still try them out?
Apparently so. The step-by-step process for this entails:
- A patient consulting with their eyecare provider (ECP) to determine whether they are an appropriate candidate for qASED
- If deemed appropriate, an ECP will then send the patient’s prescription to Ocubio.
- From there, the company will notify the patient when they need to have their blood drawn and provide a blood draw kit to bring with them
- This blood draw is scheduled and conducted by Ocubio’s phlebotomy providers
- The blood serum is then used to produce the serum eye drops at the FDA-certified blood center facility
- Once formulated, the drops are delivered directly to a patient’s home within 24 to 48 hours
Note: ECPs must first register with Ocubio in order to place orders for qASED.
Quick question: How much blood is drawn for these drops?
Anywhere from four to eight blood tubes (similar to those used during a routine blood test)—although the exact amount will depend on the drop concentration an ECP prescribes.
Got it. And what’s the dosing schedule?
Per Ocubio, that will also be determined by a patient’s ECP.
Let’s talk pricing and returns.
Pricing-wise: This will reportedly depend on the concentration of the drops an ECP prescribes to a patient.
- “Although some insurance providers may reimburse this treatment when patients submit a claim, it is typically a self-pay service,” the company noted.
- Ocubio added that it also offers 0% APR financing directly through the company.
See here for the return policy.
And reach out to the company with questions by clicking here.