Technology

IVMED-10 and IVMED-20

The iVeena lead products are IVMED-10 for routine post cataract surgery inflammation and IVMED-20 for more serious forms of post cataract surgery and to prevent Retinal Thickening.

Landscape and Problem:

Cataract surgery is the most common surgical procedure in the US, numbering about 4 million cases in 2014; by 2020 that is expected to rise 5 million. Similarly, global cataract surgery volume is expected to grow from 20 million in 2010 to 32 million in 2020. Patients undergoing cataract extraction are often prescribed 3 different eyedrops at 3 different schedules for 3 different durations, leading to poor compliance which can reduce satisfaction and sometimes compromise or delay visual recovery.

iVeena Technology:

graphic 2 updateB 100915The bioerodible dexamethasone implant (BDI) will enable drop-free cataract surgery by delivering dexamethasone to the front of the eye (treating post-surgical inflammation) and the back of the eye (preventing the complication of cystoid macular edema, which occurs in about 8.2% of patients undergoing routine cataract surgery). This will transform care by transcending the challenges of patient compliance and reducing complications, demands on instruction time on physicians and staff, and improving the experience of recovery from surgery. The BDI drug delivery device is implanted in the lens capsule at the time of surgery (a few seconds required for implantation; no additional procedure required) and releases dexamethasone either over 2 weeks (IVMED-10 for routine cases) or 6 weeks (IVMED-20 for complex cases, such as patients with diabetes or pre-existing inflammation). Its PLGA matrix degrades by hydrolysis shortly thereafter and does not alter the transparency of the intraocular lens as it is peripheral to the lens and does not migrate in the rest of the eye as it is enveloped by the capsule. It is the only drug delivery device to rest within the lens capsule of the eye and, therefore, we believe that it is the only drug delivery device capable of bidirectional drug delivery to both the front and back segments of the eye.

Issued Patent: 8,663,194

Published Articles:
www.ncbi.nlm.nih.gov/pubmed/23321274
www.ncbi.nlm.nih.gov/pubmed/24947436

IVMED-50 and IVMED-55 for Wet AMD:

Current approaches to treating wet AMD involved monthly or bimonthly injections of anti-VEGF injections inside the eye. This poses risk of pain, bleeding, infection, or retinal detachment. iVeena is developing a gene therapy relying on the AAV vector to deliver a recombinant protein, Flt23k. With this approach, injections could be done once every 12-18 months (IVMED-50). IVeena also has developed targeted nanoparticles delivered intravenously as guided missiles to deliver Flt23k every 6 weeks (IVMED-55), a strategy that recently earned iVeena a Phase 1 SBIR grant from the National Eye Institute. In preclinical experiments, this approach has been successful in mice, rats, and monkeys. This would reduce risks, improve patient experience, and potentially control the angiogenic events responsible for AMD by sustained therapy.

Issued Patent: 8,211,864

Published Articles:
www.ncbi.nlm.nih.gov/pubmed/22427553
www.ncbi.nlm.nih.gov/pubmed/25306972
www.ncbi.nlm.nih.gov/pubmed/23464925
www.ncbi.nlm.nih.gov/pmc/articles/PMC2993697
www.ncbi.nlm.nih.gov/pubmed/17460257

IVMED-60 for Diabetic Retinopathy:

Current approaches to treating diabetic retinopathy involve lasering of the retina or monthly or bimonthly injections of anti-VEGF injections inside the eye. These are reactive approaches that attack abnormal blood vessels or destroy dying retina cells without addressing the underlying pathology of blood vessel instability and lack of oxygenation of the retina. Further, these current therapies can entail risks of night blindness or peripheral vision loss (laser), or pain, bleeding, infection, or retinal detachment (injections). iVeena is developing a gene therapy relying on the AAV vector to deliver a recombinant protein targeting the Tie2 receptor, which in our preclinical experiments, stabilizes the retinal blood vessels, improves retinal tissue oxygenation, and reduces the levels of VEGF within the eye. With this approach, injections could be done once every 12-18 months. This would reduce risks, improve patient experience, and potentially control the angiogenic events responsible for diabetic retinopathy by sustained therapy.

Published Articles:
www.ncbi.nlm.nih.gov/pubmed/22427553
www.ncbi.nlm.nih.gov/pubmed/25306972
www.ncbi.nlm.nih.gov/pubmed/23464925
www.ncbi.nlm.nih.gov/pmc/articles/PMC2993697
www.ncbi.nlm.nih.gov/pubmed/17460257

IVMED-70 for Glaucoma

High pressure in the eye can damage the optic nerve and slowly lead to progressive loss of peripheral and then central vision. This is glaucoma, the second leading cause of blindness in the US (affecting 3 million Americans) and in the world (afflicting 70 million patients globally). Patients often have to take various eyedrops at various schedules indefinitely, again with substantial non-adherence. iVeena is developing a device, IVMED-70, to reduce intraocular pressure with an easy-to-perform surgery with low risk.

The Schlemm’s stent-sieve will open the outflow pathway system in glaucoma patients from an approach that does not enter the eye or leave an opening for bacteria to enter the eye, thereby reducing infection and surgical time and risk. This surgical approach holds the promise of reducing or eliminating the need for eyedrops.