The number of adults at risk for vision loss grew substantially from 2002-2017, from 65 million to 93 million. According to the CDC, more than 4.2 million Americans suffer from low vision or blindness. The leading causes of vision loss are age-related eye diseases such as age-related macular degeneration (AMD), cataract, diabetic retinopathy, and glaucoma. AMD affects more than 1.8 million Americans ages 40 years and older, and 7.3 million more are at risk of developing AMD due to large drusen, also known as small yellow or white spots on the retina.
Concurrent with the rise in prevalence of eye diseases, the amount and size of investments in ophthalmology biotechs have also increased in the past decade. CipherBio PRO’s Eye Disease Insights reveals that between 2019-2021, 86 biotech companies developing eye disease treatments raised a total of $13.3 Billion in proceeds and were invested in by over 300 investors. The top indications include dry and wet AMD, diabetic macular edema, and glaucoma.
18 companies are working on AMD, with the majority of the wet and dry AMD product candidates in preclinical trials. The companies furthest along in clinical trials for wet AMD are Affamed Therapeutics and Noveome Biotherapeutics, Inc. with treatments in phase 1 trials. Affamed’s product AM003 inhibits vascular endothelial growth factor A (VEGF-A) to treat wet AMD. Affamed most recently completed a $170M series B round in March 2021, the largest series B, and the 5th largest funding round for eye disease indications. The series B was led by Lake Blue Capital and backed by new investors Partners Investment, Superstring Capital, Orion Science Capital, and Fountainhead Partners, along with its founding investor the CBC Group.
Noveome’s product ST266 reduces inflammation and swelling to help preserve vision in patients with wet AMD. Most treatments for wet AMD require frequent injections to the eye, but ST266 instead uses a non-invasive intranasal delivery. Noveome is also studying the application of ST266 in anti-inflammatory applications for sepsis, COVID-19, and traumatic brain injury. Noveome to date has been awarded $115M in funding from the department of defense and most recently raised a $15M series D funding round.
Both diabetic macular edema and glaucoma also have therapeutics advancing through clinical trials. Oculis, a biotech company out of Lausanne, Switzerland has the most advanced product for diabetic macular edema, OCS-01, currently in a phase 3 trial. OCS-01 is an eye drop, designed as a non-invasive alternative for patients previously limited to injections and implants. Oculis most recently completed a $57 series C funding round to advance OCS-01 to phase 3 led by BCVF management and Hyfinity Investments.
The farthest advanced treatment for glaucoma is Affamed Therapeutics’ product AM008, in phase 2 clinical trial. AM008 is an implant that delivers travoprost, a drug that lowers the pressure in the eye for four to six months.
Notably, the top approach for eye disease indications is gene therapy. Gene therapy is a therapeutic approach rapidly growing in biotech, and eye diseases are one of the indications most impacted by this growth. 20 companies have products in preclinical development, along with 2 in phase 1, 3 in phase 1/2, and 3 in phase 2, totaling 22 companies and $6.3B in investments. Eyevensys, Gyroscope Therapeutics, and Nanoscope Therapeutics all have gene therapies for various eye disease indications that are in phase 2 clinical trials. Gyroscope Therapeutics is developing a therapy for Geographic Atrophy that develops secondary to dry AMD. Most recently, Gyroscope completed a $148M series C round, the second-largest series C round in the eye disease indication, led by Forbion Capital Partners. Gene therapy allows for sustained treatment delivery by way of vectors that replace or supplement defective genes. This approach allows for only one treatment, in comparison to current therapies that require frequent injections.
With 2021 already having 33 deals representing $2.2 Billion in invested capital, the rest of the year looks promising for advancing eye disease treatments through the clinical pipeline. With the prevalence of eye diseases, the life science industry is responding by developing treatments to help prevent vision loss and restore sight for millions of adults.