iVeena Delivery Systems

iVeena’s BDI device

Eliminating Eye Injections & Post-Surgery Eye Drops

According to the National Eye Institute, over half of all Americans will develop a cataract by age 80,[4] a staggering figure that illustrates why cataract surgeries are the most frequently performed operation in the world.

Jerry Simmons, Dr. Bala Ambati, Sarah Molokhia

In a normal eye, a clear lens helps to focus light or images on the retina. Once light passes through the lens and hits the retina it is changed into nerve signals, which are subsequently sent to the brain as images. If the lens is cloudy, due to a cataract, the image one sees will be blurred.

The most common cataract surgeries are done with a small incision where the cataract is removed and replaced with a man-made lens, also known as an intraocular lens. Post-surgery patients are prescribed eye drops, with most receiving three different types. These drops need to be administered in distinct intervals over multiple durations. “Following this regimen can be tricky,” explains Bala Ambati, M.D., Ph.D., M.B.A., professor of ophthalmology at the U’s Moran Eye Center and president and founder of iVeena Delivery Systems. “Compliance rates with eye drops post-surgery are only about 45 percent.” Failing to follow the post surgery regimen of eye drops can lead to inflammation and costly subsequent ophthalmological interventions.

Eliminating Post-Cataract Surgery Eye Drops

This low level of patient compliance led Dr. Ambati to search for potential solutions only to discover that there was nothing on the market that effectively addressed post-surgery compliance issues. Sensing an opening, Dr. Ambati began experimenting with methods that would significantly boost compliance. Ultimately he realized that 100 percent compliance could only be achieved without patients having to do anything.

This realization led Dr. Ambati to develop his Bioerodible Dexamethasone Implant (BDI). This breakthrough device is designed to completely eliminate the need for eye drops post-cataract surgery. It is implanted in the back of the eye during cataract surgery and delivers drug doses to both the front and back of the eye. It only needs to release a fraction of the amount of drugs that eye drops contain because it is implanted in the area where the drugs are needed most: the area behind the eye’s lens. After the drug has been delivered over anywhere from two to six weeks (depending on how complex the cataract case is), the product safely degrades by hydrolysis.

iVeena Moving BDI to Market

U-spinout iVeena was formed in 2010 to commercialize the BDI device. “We have completed in vivo studies on 65 New Zealand white rabbits, all of whom were successfully implanted with the device,” describes Dr. Ambati. “The device both successfully treated post-cataract inflammation and reduced retinal thickening in the rabbits.”

Dr. Bala Ambati, President and Founder, iVeena

iVeena is now planning to move into Phase 1 clinical trials. Following these and subsequent FDA approval, the company expects BDI to be a major breakthrough within the larger ophthalmological community. iVeena’s CEO, Jerry Simmons, explains that in addition to the patient benefit of not having to take eye drops post-cataract surgery, the estimated savings to the government for BDI on both eye drops and post-surgery complications will be approximately $270 million annually. This is because Medicare pays for 55 percent of cataract surgeries and their subsequent regimen of eye drops. At a price point of around $200, iVeena estimates that it will be saving the government approximately $140 per eye.

An Experienced Leader

Simmons’ recent arrival was a calculated move by Dr. Ambati to bring on a tested leader to advance the company beyond early preclinical trials. “We had gone as far as we could in the lab,” explains Dr. Ambati. “We needed to bring on an experienced leader who could move our products to market.” A seasoned large and early-stage pharmaceutical veteran, Simmons brings a wealth of experience to iVeena having spearheaded two IPOs and several successful corporate transactions.

In addition to BDI, iVeena is developing three additional products. As with its lead product, BDI, iVeena’s other products are each designed to eliminate the need for eye drops or eye injections for various, targeted conditions.

“iVeena’s pipeline of products is truly innovative and disruptive,” explains Beth Drees, director of the Health Sciences team at TVC. “Although each product is still early, the ability to eliminate eye drops and painful eye injections will significantly help millions of people who have cataract surgeries and millions of others struggling with macular degeneration, diabetic retinopathy, or glaucoma.”

The Ophthalmologist: The Power List 2015, Top 40 Under 40

In 2015 The Ophthalmologist magazine ranked Dr. Bala Ambati as the number one up-and-coming individual in ophthalmology. The selection process involved nominations from fellow ophthalmologists followed by a rigorous judging process.

From the publication:

“[Dr. Ambati] holds the distinction of being the world’s youngest person to graduate from medical school – at the age of 17 – and since specializing in ophthalmology, has gone on to receive many awards, including the Ludwig von Sallmann Clinician-Scientist Award from the ARVO Foundation in 2014, and in 2013, the Troutman-Véronneau Prize from the Pan-American Association of Ophthalmology. Asked why he chose the career that he did: ‘At four, I was burned on both legs and underwent three surgeries in three months. Seeing the doctors and nurses was formative, and a love for biology flowed into medicine.’ He devotes several weeks per year to volunteer work, including overseas missions with ORBIS, a nonprofit organization with a Flying Eye Hospital, and he hopes to support the opening of an eye clinic in India too.

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And [Dr. Ambati’s] advice to those wishing to succeed? ‘Stand in the shoes of patients, students, mentors, staff, family, and colleagues. Give back in research, service, teaching, or policy.’”[5]

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[4] “Facts About Cataract,” National Eye Institute, accessed September 14, 2015, https://nei.nih.gov/health/cataract/cataract_facts.

[5] “The Power List 2015: Top 40 Under 40,” The Ophthalmologist, accessed September 14, 2015, https://theophthalmologist.com/the-power-list-2015/.